Scholars@Duke
Emmanuel Benjamin Walter Jr.

Emmanuel Benjamin Walter Jr.

Professor of Pediatrics
Pediatrics, General Pediatrics and Adolescent Health
walte002@mc.duke.edu
Duke University PO Box 106008, Durham, NC 27710-6008
65 TW Alexander Drive, PO Box 13687, Durham, NC 27709

Selected Publications

Apnea After 2-Month Vaccinations in Hospitalized Preterm Infants: A Randomized Clinical Trial.

Journal Article JAMA Pediatr · March 1, 2025 IMPORTANCE: Preterm infants are recommended to receive most vaccinations at the same postnatal age as term infants. Studies have inconsistently observed an increased risk for postvaccination apnea in preterm infants. OBJECTIVE: To compare the proportions o ... Full text Link to item Cite

Anti-neuraminidase and anti-hemagglutinin stalk responses to different influenza a(H7N9) vaccine regimens.

Journal Article Vaccine · February 15, 2025 INTRODUCTION: Pandemic influenza vaccine development focuses on the hemagglutinin (HA) antigen for potency and immunogenicity. Antibody responses targeting the neuraminidase (NA) antigen, or the HA stalk domain have been implicated in protection against in ... Full text Link to item Cite

Evaluation of the safety profile and intrapulmonary pharmacokinetics of intravenous fosfomycin in healthy adults.

Journal Article Antimicrob Agents Chemother · February 13, 2025 UNLABELLED: This Phase 1 trial described the intrapulmonary pharmacokinetics and safety profile of IV fosfomycin in healthy participants. Fosfomycin, a broad-spectrum antibiotic mainly used to treat urinary tract infections, is being considered for treatme ... Full text Link to item Cite

Neutralizing Antibody Immune Correlates for a Recombinant Protein Vaccine in the COVAIL Trial.

Journal Article Clin Infect Dis · February 5, 2025 For COVAIL recipients of a coronavirus disease 2019 (COVID-19) Sanofi booster vaccine, neutralizing antibody titers were assessed as a correlate of risk (CoR) of COVID-19. Peak and exposure-proximal titers were inverse CoRs with covariate-adjusted hazard r ... Full text Link to item Cite

Population Pharmacokinetics of Meropenem Across the Adult Lifespan.

Journal Article Clin Pharmacokinet · February 2025 BACKGROUND AND OBJECTIVE: We conducted an opportunistic pharmacokinetic study to evaluate the population pharmacokinetics of meropenem, an antimicrobial commonly used to treat Gram-negative infections in adults of different ages, including older adults, an ... Full text Link to item Cite

Neutralizing antibody immune correlates in COVAIL trial recipients of an mRNA second COVID-19 vaccine boost.

Journal Article Nat Commun · January 17, 2025 Neutralizing antibody titer has been a surrogate endpoint for guiding COVID-19 vaccine approval and use, although the pandemic's evolution and the introduction of variant-adapted vaccine boosters raise questions as to this surrogate's contemporary performa ... Full text Link to item Cite

New Approaches to Respiratory Syncytial Virus Prevention and Treatment.

Journal Article Annu Rev Med · January 2025 There have been several recent advances in the prevention of lower respiratory tract disease (LRTD) due to respiratory syncytial virus (RSV) infection in older adults and young children. Three different vaccines are now approved for use in older adults; on ... Full text Link to item Cite

Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines: A Randomized Clinical Trial.

Journal Article JAMA Netw Open · November 4, 2024 IMPORTANCE: Limited randomized clinical trial data exist on the safety of simultaneous administration of COVID-19 and influenza vaccines. OBJECTIVE: To compare the reactogenicity, safety, and changes in health-related quality of life (HRQOL) after simultan ... Full text Link to item Cite

Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial.

Journal Article JAMA Netw Open · October 1, 2024 IMPORTANCE: Quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) and adjuvanted recombinant zoster vaccine (RZV) contain novel adjuvants. Data are limited on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effect ... Full text Link to item Cite

SARS-CoV-2 RNA and Nucleocapsid Antigen Are Blood Biomarkers Associated With Severe Disease Outcomes That Improve in Response to Remdesivir.

Journal Article J Infect Dis · September 23, 2024 BACKGROUND: Although antivirals remain important for the treatment COVID-19, methods to assess treatment efficacy are lacking. Here, we investigated the impact of remdesivir on viral dynamics and their contribution to understanding antiviral efficacy in th ... Full text Link to item Cite

Bivalent Omicron BA.4/BA.5 BNT162b2 Vaccine in 6-Month- to <12-Year-Olds.

Journal Article J Pediatric Infect Dis Soc · August 24, 2024 BACKGROUND: With the future epidemiology and evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uncertain, the use of safe and effective coronavirus disease 2019 (COVID-19) vaccines in pediatric populations remains important. METHODS ... Full text Link to item Cite

Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine.

Journal Article J Infect Dis · August 16, 2024 BACKGROUND: MF59-adjuvanted gB subunit (gB/MF59) vaccine demonstrated approximately 50% efficacy against human cytomegalovirus (HCMV) acquisition in multiple clinical trials, suggesting that efforts to improve this vaccine design might yield a vaccine suit ... Full text Link to item Cite

A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered With and Without AS03 Adjuvant in Healthy US Adults.

Journal Article Clin Infect Dis · June 14, 2024 INTRODUCTION: A surge of human influenza A(H7N9) cases began in 2016 in China from an antigenically distinct lineage. Data are needed about the safety and immunogenicity of 2013 and 2017 A(H7N9) inactivated influenza vaccines (IIVs) and the effects of AS03 ... Full text Link to item Cite

Trends in RSV testing patterns among infants presenting with bronchiolitis: Results from four United States health systems, 2015-2023.

Journal Article Ann Epidemiol · June 2024 BACKGROUND: Bronchiolitis due to respiratory syncytial virus (RSV) is the leading cause of hospitalization among American infants. The overall burden of RSV among infants has been historically under-estimated due to variable testing practices, particularly ... Full text Link to item Cite

A chimeric haemagglutinin-based universal influenza virus vaccine boosts human cellular immune responses directed towards the conserved haemagglutinin stalk domain and the viral nucleoprotein.

Journal Article EBioMedicine · June 2024 BACKGROUND: The development of a universal influenza virus vaccine, to protect against both seasonal and pandemic influenza A viruses, is a long-standing public health goal. The conserved stalk domain of haemagglutinin (HA) is a promising vaccine target. H ... Full text Link to item Cite

Late-Season Influenza Vaccine Effectiveness Against Medically Attended Outpatient Illness, United States, December 2022-April 2023.

Journal Article Influenza Other Respir Viruses · June 2024 BACKGROUND: The 2022-23 US influenza season peaked early in fall 2022. METHODS: Late-season influenza vaccine effectiveness (VE) against outpatient, laboratory-confirmed influenza was calculated among participants of the US Influenza VE Network using a tes ... Full text Link to item Cite

Geographic Progression of Infant Respiratory Syncytial Virus Associated Bronchiolitis Across the United States Before and Since the Onset of COVID-19: Results From Four Health Systems, 2015-2023.

Journal Article Influenza Other Respir Viruses · May 2024 BACKGROUND: Respiratory syncytial virus (RSV) is a substantial cause of infant morbidity and mortality due to seasonal peaks of bronchiolitis across the United States. Clinical and viral surveillance plays a pivotal role in helping hospital systems prepare ... Full text Link to item Cite

Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials

Journal Article eClinicalMedicine · March 1, 2024 Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup of p ... Full text Cite

Interim Estimates of 2023-24 Seasonal Influenza Vaccine Effectiveness - United States.

Journal Article MMWR Morb Mortal Wkly Rep · February 29, 2024 In the United States, annual influenza vaccination is recommended for all persons aged ≥6 months. Using data from four vaccine effectiveness (VE) networks during the 2023-24 influenza season, interim influenza VE was estimated among patients aged ≥6 months ... Full text Link to item Cite

Influenza Vaccine Administration and Effectiveness Among Children and Adults With Glomerular Disease.

Journal Article Kidney Int Rep · February 2024 INTRODUCTION: Influenza infections contribute to excess healthcare utilization, morbidity, and mortality in individuals with glomerular disease (GD); however, influenza vaccination may not yield protective immune responses in this high-risk patient populat ... Full text Link to item Cite

Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults.

Journal Article Vaccine · January 12, 2024 BACKGROUND: Human infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continued to occur in annual waves. In the 2016/2017 fifth wave, Yangtze River Delta (YRD) lineage viruses, which differed antigenically from those ... Full text Link to item Cite

An ADaptivE PrenaTal (ADEPT) intervention to increase childhood vaccinations: Protocol for a cluster randomized trial and nested mixed methods evaluation.

Journal Article PLoS One · 2024 BACKGROUND: There is limited evidence to assess if interventions implemented during pregnancy proactively mitigate parental vaccine hesitancy and promote timely vaccination among children after birth. This study protocol describes the evaluation of an ADap ... Full text Link to item Cite

Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

Journal Article J Infect Dis · December 20, 2023 We compared the serologic responses of 1 dose versus 2 doses of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with a variant vaccine did not increase the magnitude or the durability of the ser ... Full text Link to item Cite

Engineered immunogens to elicit antibodies against conserved coronavirus epitopes.

Journal Article Nat Commun · November 30, 2023 Immune responses to SARS-CoV-2 primarily target the receptor binding domain of the spike protein, which continually mutates to escape acquired immunity. Other regions in the spike S2 subunit, such as the stem helix and the segment encompassing residues 815 ... Full text Link to item Cite

Risk of COVID-19 after natural infection or vaccination.

Journal Article EBioMedicine · October 2023 BACKGROUND: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patie ... Full text Link to item Cite

Engineered Immunogens to Elicit Antibodies Against Conserved Coronavirus Epitopes.

Journal Article bioRxiv · September 17, 2023 Immune responses to SARS-CoV-2 primarily target the receptor binding domain of the spike protein, which continually mutates to escape acquired immunity. Other regions in the spike S2 subunit, such as the stem helix and the segment encompassing residues 815 ... Full text Link to item Cite

Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Journal Article Nat Med · September 2023 Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed ... Full text Link to item Cite

Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial.

Journal Article Clin Infect Dis · August 22, 2023 In a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein ... Full text Link to item Cite

A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults.

Journal Article J Infect Dis · August 11, 2023 BACKGROUND: We evaluated the associations between baseline influenza virus-specific hemagglutination inhibition (HAI) and microneutralization (MN) titers and subsequent symptomatic influenza virus infection in a controlled human infection study. METHODS: W ... Full text Link to item Cite

Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial.

Journal Article Immun Ageing · July 1, 2023 BACKGROUND: Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A ... Full text Link to item Cite

Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

Journal Article medRxiv · June 10, 2023 In this brief report, we compare the magnitude and durability of the serologic response of one versus two doses (separated by 56 days) of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. ... Full text Link to item Cite

Efficacy and safety of azithromycin versus placebo to treat lower respiratory tract infections associated with low procalcitonin: a randomised, placebo-controlled, double-blind, non-inferiority trial.

Journal Article Lancet Infect Dis · April 2023 BACKGROUND: Lower respiratory tract infections are frequently treated with antibiotics, despite a viral cause in many cases. It remains unknown whether low procalcitonin concentrations can identify patients with lower respiratory tract infection who are un ... Full text Open Access Link to item Cite

Immunogenicity of the BA.1 and BA.4/BA.5 SARS-CoV-2 Bivalent Boosts: Preliminary Results from the COVAIL Randomized Clinical Trial.

Journal Article medRxiv · March 31, 2023 In a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent SARS-CoV-2 mRNA vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein combined with wildtype spike. Responses against SARS-CoV-2 varian ... Full text Link to item Cite

Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.

Journal Article N Engl J Med · February 16, 2023 BACKGROUND: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children. METHODS: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial ... Full text Link to item Cite

Safety and Immunogenicity of Influenza A/H5N8 Virus Vaccine in Healthy Adults: Durability and Cross-reactivity of Antibody Responses.

Journal Article Clin Infect Dis · January 5, 2023 BACKGROUND: Influenza A/H5N8 viruses infect poultry and wild birds in many countries. In 2021, the first human A/H5N8 cases were reported. METHODS: We conducted a phase I, cohort-randomized, double-blind, controlled trial of inactivated influenza A/H5N8 va ... Full text Link to item Cite

Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan.

Journal Article Clin Pharmacokinet · January 2023 BACKGROUND AND OBJECTIVE: Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. Using an opportunistic study design, we evaluated the pharmacokinetics of piperacillin/tazobactam as a probe drug to evaluate changes in an ... Full text Link to item Cite

Plain language summary of Pfizer-BioNTech BNT162b2 vaccine protection against COVID-19 and its safety in participants 12- to 15-years-old

Journal Article Future Virology · January 1, 2023 What is this summary about? This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in May 2021. This summar ... Full text Cite

H3N2 influenza hemagglutination inhibition method qualification with data driven statistical methods for human clinical trials.

Journal Article Front Immunol · 2023 INTRODUCTION: Hemagglutination inhibition (HAI) antibody titers to seasonal influenza strains are important surrogates for vaccine-elicited protection. However, HAI assays can be variable across labs, with low sensitivity across diverse viruses due to lack ... Full text Link to item Cite

Brief therapy for community-acquired pneumonia is superior to traditional therapy: findings from SCOUT-CAP RCT

Journal Article Quaderni ACP · January 1, 2023 This US multicenter study of good methodological quality, with an innovative method of enrollment of 380 uncomplicated cases of community-acquired pneumonia (CAP) on the third day of antibiotic therapy, is the first one to demonstrate the superiority a sho ... Full text Cite

Infant Antibody Repertoires during the First Two Years of Influenza Vaccination.

Journal Article mBio · December 20, 2022 The first encounter with influenza virus biases later immune responses. This "immune imprinting," formerly from infection within a few years of birth, is in the United States now largely from immunization with a quadrivalent, split vaccine (IIV4 [quadrival ... Full text Link to item Cite

Key stakeholder perspectives on challenges and opportunities for rural HPV vaccination in North and South Carolina.

Journal Article Hum Vaccin Immunother · November 30, 2022 The objective of this study was to identify factors at the individual, provider, and systems levels that serve as challenges or opportunities for increasing adolescent vaccination-including Human Papillomavirus (HPV) vaccination-in rural communities in the ... Full text Link to item Cite

Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study.

Journal Article Lancet Child Adolesc Health · November 2022 BACKGROUND: Data on medium-term outcomes in indivduals with myocarditis after mRNA COVID-19 vaccination are scarce. We aimed to assess clinical outcomes and quality of life at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adol ... Full text Link to item Cite

Gastrointestinal Microbiome Disruption and Antibiotic-Associated Diarrhea in Children Receiving Antibiotic Therapy for Community-Acquired Pneumonia.

Journal Article J Infect Dis · September 21, 2022 Antibiotic-associated diarrhea (AAD) is a common side effect of antibiotics. We examined the gastrointestinal microbiota in children treated with β-lactams for community-acquired pneumonia. Data were from 66 children (n = 198 samples), aged 6-71 months, en ... Full text Link to item Cite

Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.

Journal Article Lancet Respir Med · September 2022 BACKGROUND: Baricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to ... Full text Open Access Link to item Cite

Association of caregiver attitudes with adolescent HPV vaccination in 13 southern US states.

Journal Article Vaccine X · August 2022 BACKGROUND AND OBJECTIVES:  HPV vaccination coverage is lower than that of other adolescent vaccines in the southern US. This study sought to characterize caregiver attitudes associated with adolescent HPV vaccination in the southern US and to inform inter ... Full text Link to item Cite

Clinical Features and Treatment Outcomes of Pulmonary Mycobacterium avium-intracellulare Complex With and Without Coinfections.

Journal Article Open Forum Infect Dis · August 2022 Coinfections are more common in patients with cystic fibrosis and bronchiectasis. Infiltrates on imaging studies are seen more commonly in patients with coinfections, but coinfections did not affect treatment outcomes of pulmonary Mycobacterium avium compl ... Full text Open Access Link to item Cite

SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses.

Journal Article medRxiv · July 15, 2022 BACKGROUND: Protection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines. METHODS: This phase 2 open-label, randomize ... Full text Link to item Cite

Comparison of the Respiratory Resistomes and Microbiota in Children Receiving Short versus Standard Course Treatment for Community-Acquired Pneumonia.

Journal Article mBio · April 26, 2022 Pediatric community-acquired pneumonia (CAP) is often treated with 10 days of antibiotics. Shorter treatment strategies may be effective and lead to less resistance. The impact of duration of treatment on the respiratory microbiome is unknown. Data are fro ... Full text Link to item Cite

First-in-Human Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Doses of NTM-1633, a Novel Mixture of Monoclonal Antibodies against Botulinum Toxin E.

Journal Article Antimicrob Agents Chemother · April 19, 2022 Botulism is a rare, life-threatening paralytic disease caused by botulinum neurotoxin (BoNT). Available treatments including an equine antitoxin and human immune globulin are given postexposure and challenging to produce and administer. NTM-1633 is an equi ... Full text Link to item Cite

Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination-United States, December 2020 to August 2021.

Journal Article Ann Intern Med · April 2022 BACKGROUND: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebra ... Full text Link to item Cite

Prevention of pneumococcal infections in childhood: two decades of progress.

Journal Article Curr Opin Pediatr · April 1, 2022 PURPOSE OF REVIEW: This review highlights progress in combating pediatric pneumococcal disease in the era of pneumococcal conjugate vaccines (PCVs). This review is timely given the development of increased valency PCVs for potential use in children. RECENT ... Full text Link to item Cite

Safety of Live Attenuated Influenza Vaccine in Children With Asthma.

Journal Article Pediatrics · April 1, 2022 BACKGROUND AND OBJECTIVES: Asthma is considered a precaution for use of quadrivalent live attenuated influenza vaccine (LAIV4) in persons aged ≥5 years because of concerns for wheezing events. We evaluated the safety of LAIV4 in children with asthma, compa ... Full text Link to item Cite

Short- vs Standard-Course Outpatient Antibiotic Therapy for Community-Acquired Pneumonia in Children: The SCOUT-CAP Randomized Clinical Trial.

Journal Article JAMA Pediatr · March 1, 2022 IMPORTANCE: Childhood community-acquired pneumonia (CAP) is usually treated with 10 days of antibiotics. Shorter courses may be effective with fewer adverse effects and decreased potential for antibiotic resistance. OBJECTIVE: To compare a short (5-day) vs ... Full text Open Access Link to item Cite

Population Pharmacokinetics of Moxifloxacin in Children.

Journal Article Paediatr Drugs · March 2022 BACKGROUND/OBJECTIVE: Moxifloxacin is a fluoroquinolone that is commonly used in adults, but not children. Certain clinical situations compel pediatric clinicians to use moxifloxacin, despite its potential for toxicity and limited pharmacokinetics (PK) dat ... Full text Link to item Cite

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

Journal Article N Engl J Med · January 6, 2022 BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investiga ... Full text Link to item Cite

Predictors of HPV vaccination in the southern US: A survey of caregivers from 13 states.

Journal Article Vaccine · December 17, 2021 BACKGROUND AND OBJECTIVES: Despite a high burden of human papillomavirus (HPV)-attributable cancers, the southern US lags other regions in HPV vaccination coverage. This study sought to characterize and contextualize predictors of HPV vaccination in the so ... Full text Link to item Cite

Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial.

Journal Article Lancet Respir Med · December 2021 BACKGROUND: Functional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compare ... Full text Open Access Link to item Cite

A randomized, double-blind, placebo-controlled clinical trial of fluconazole as early empiric treatment of coccidioidomycosis pneumonia (Valley Fever) in adults presenting with community-acquired pneumonia in endemic areas (FLEET-Valley Fever).

Journal Article Contemp Clin Trials Commun · December 2021 INTRODUCTION: Coccidioidomycosis is a fungal infection endemic in the southwestern United States (US). Primary pulmonary coccidioidomycosis (PPC) is a leading cause of community-acquired pneumonia (CAP) in this region, although its diagnosis is often delay ... Full text Open Access Link to item Cite

Severe Acute Respiratory Syndrome Coronavirus 2 Infections Among Children in the Biospecimens from Respiratory Virus-Exposed Kids (BRAVE Kids) Study.

Journal Article Clin Infect Dis · November 2, 2021 BACKGROUND: Child with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection typically have mild symptoms that do not require medical attention, leaving a gap in our understanding of the spectrum of SARS-CoV-2-related illnesses that the vi ... Full text Open Access Link to item Cite

Examining Associations between Knowledge and Vaccine Uptake Using the Human Papillomavirus Knowledge Questionnaire (HPV-KQ).

Journal Article Am J Health Behav · September 30, 2021 Objectives: Understanding the relationship between human papillomavirus (HPV) knowledge and vaccination behavior is important to inform public health interventions, yet few validated HPV knowledge scales exist. This study describes development of the Human ... Full text Link to item Cite

Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.

Journal Article N Engl J Med · July 15, 2021 BACKGROUND: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population ... Full text Link to item Cite

Safety, Tolerability, and Pharmacokinetics of NTM-1632, a Novel Mixture of Three Monoclonal Antibodies against Botulinum Toxin B.

Journal Article Antimicrob Agents Chemother · June 17, 2021 Botulism is a rare, life-threatening paralytic disease caused by Clostridium botulinum neurotoxin (BoNT). Available treatments, including an equine antitoxin and human immune globulin, are given postexposure and challenging to produce and administer. NTM-1 ... Full text Link to item Cite

Variability in the Management of Adults With Pulmonary Nontuberculous Mycobacterial Disease.

Journal Article Clin Infect Dis · April 8, 2021 BACKGROUND: The increasing global prevalence of pulmonary nontuberculous mycobacteria (NTM) disease has called attention to challenges in NTM diagnosis and management. This study was conducted to understand management and outcomes of patients with pulmonar ... Full text Link to item Cite

Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial.

Journal Article JAMA Netw Open · January 4, 2021 IMPORTANCE: Trivalent adjuvanted inactivated influenza vaccine (aIIV3) and trivalent high-dose inactivated influenza vaccine (HD-IIV3) are US-licensed for adults aged 65 years and older. Data are needed on the comparative safety, reactogenicity, and health ... Full text Link to item Cite

A chimeric hemagglutinin-based universal influenza virus vaccine approach induces broad and long-lasting immunity in a randomized, placebo-controlled phase I trial.

Journal Article Nat Med · January 2021 Seasonal influenza viruses constantly change through antigenic drift and the emergence of pandemic influenza viruses through antigenic shift is unpredictable. Conventional influenza virus vaccines induce strain-specific neutralizing antibodies against the ... Full text Link to item Cite

Vaccine Hesitancy in North Carolina: The Elephant in the Room?

Journal Article N C Med J · 2021 Vaccine hesitancy is a persistent but under-prioritized issue in North Carolina. Plans are needed for systematic data collection on vaccine hesitancy trends, enhancing access to trusted sources of information, strengthening policies encouraging vaccination ... Full text Link to item Cite

Remdesivir for the Treatment of Covid-19 - Final Report.

Journal Article N Engl J Med · November 5, 2020 BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS: We conducted a double-blind, randomized, placebo-controlled tr ... Full text Link to item Cite

Antibody binding to native cytomegalovirus glycoprotein B predicts efficacy of the gB/MF59 vaccine in humans.

Journal Article Sci Transl Med · November 4, 2020 Human cytomegalovirus (CMV) is the most common infectious cause of infant brain damage and posttransplant complications worldwide. Despite the high global burden of disease, vaccine development to prevent infection remains hampered by challenges in generat ... Full text Link to item Cite

SARS-CoV-2 Infections Among Children in the Biospecimens from Respiratory Virus-Exposed Kids (BRAVE Kids) Study.

Journal Article medRxiv · September 1, 2020 BACKGROUND: Children with SARS-CoV-2 infection typically have mild symptoms that do not require medical attention, leaving a gap in our understanding of the spectrum of illnesses that the virus causes in children. METHODS: We conducted a prospective cohort ... Full text Open Access Link to item Cite

Delayed dosing intervals for quadrivalent human papillomavirus vaccine do not reduce antibody avidity.

Conference Hum Vaccin Immunother · August 2, 2020 The quadrivalent HPV vaccine (4vHPV) was originally recommended as a three-dose series (0/2/6 months), though delays in completing the series frequently occur. We previously found delayed dosing in girls resulted in similar or higher antibody titers compar ... Full text Link to item Cite

A Pharmacoepidemiologic Study of the Safety and Effectiveness of Clindamycin in Infants.

Journal Article Pediatr Infect Dis J · March 2020 BACKGROUND: Despite the absence of adequate safety or efficacy data, clindamycin is widely prescribed in the neonatal intensive care unit. We evaluated the association between clindamycin exposure and adverse events, as well as antibiotic effectiveness in ... Full text Link to item Cite

Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations.

Journal Article Pediatrics · March 2020 BACKGROUND: Administering inactivated influenza vaccine (IIV), 13-valent pneumococcal conjugate vaccine (PCV13), and diphtheria-tetanus-acellular pertussis (DTaP) vaccine together has been associated with increased risk for febrile seizure after vaccinatio ... Full text Link to item Cite

Immunogenicity of chimeric haemagglutinin-based, universal influenza virus vaccine candidates: interim results of a randomised, placebo-controlled, phase 1 clinical trial.

Journal Article Lancet Infect Dis · January 2020 BACKGROUND: Influenza viruses cause substantial annual morbidity and mortality globally. Current vaccines protect against influenza only when well matched to the circulating strains. However, antigenic drift can cause considerable mismatches between vaccin ... Full text Link to item Cite

Effect of recent seasonal influenza vaccination on serum antibody responses to candidate pandemic influenza A/H5N1 vaccines: A meta-analysis.

Journal Article Vaccine · September 3, 2019 Recent studies have suggested that among those receiving seasonal influenza vaccine (SIV), reduced immunogenicity is observed in recently vaccinated (RV; within the past season or 2) persons when compared with those not recently vaccinated (NRV). We perfor ... Full text Link to item Cite

Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents.

Journal Article Vaccine · August 23, 2019 OBJECTIVE: In response to the emergence of influenza viruses with pandemic potential, we evaluated a swine-origin influenza A/H3N2 variant (H3N2v) vaccine in children. STUDY DESIGN: This multicenter phase II open-label study assessed the safety and immunog ... Full text Link to item Cite

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season.

Journal Article MMWR Recomm Rep · August 23, 2019 This report updates the 2018-19 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2018;67[No. RR-3]). Routine annual influenza vaccination is re ... Full text Link to item Cite

Japanese Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices.

Journal Article MMWR Recomm Rep · July 19, 2019 This report updates the 2010 recommendations from the CDC Advisory Committee on Immunization Practices (ACIP) regarding prevention of Japanese encephalitis (JE) among U.S. travelers and laboratory workers (Fischer M, Lindsey N, Staples JE, Hills S. Japanes ... Full text Link to item Cite

An observer blinded, randomized, placebo-controlled, phase I dose escalation trial to evaluate the safety and immunogenicity of an inactivated West Nile virus Vaccine, HydroVax-001, in healthy adults.

Journal Article Vaccine · July 9, 2019 BACKGROUND: West Nile virus (WNV) is the most common mosquito-borne infection in the United States. HydroVax-001 WNV is a hydrogen peroxide inactivated, whole virion (WNV-Kunjin strain) vaccine adjuvanted with aluminum hydroxide. METHODS: We performed a ph ... Full text Link to item Cite

Group B Streptococcus (GBS) Colonization and Disease among Pregnant Women: A Historical Cohort Study

Conference Infectious Diseases in Obstetrics and Gynecology · January 1, 2019 Background. Maternal GBS colonization is associated with early-onset neonatal sepsis and extensive efforts are directed to preventing this complication. Less is known about maternal risks of GBS colonization. We seek to provide a modern estimate of the inc ... Full text Cite

Group B Streptococcus (GBS) Colonization and Disease among Pregnant Women: A Historical Cohort Study.

Journal Article Infect Dis Obstet Gynecol · 2019 BACKGROUND: Maternal GBS colonization is associated with early-onset neonatal sepsis and extensive efforts are directed to preventing this complication. Less is known about maternal risks of GBS colonization. We seek to provide a modern estimate of the inc ... Full text Open Access Link to item Cite

Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women.

Journal Article Vaccine · October 8, 2018 OBJECTIVE: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertusiss (Tdap) vaccine is recommended during each pregnancy, regardless of prior receipt. Data on reactogenicity and immunogenicity, particularly after repeated Tdap, are limited. We com ... Full text Link to item Cite

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices-United States, 2018-19 Influenza Season.

Journal Article MMWR Recomm Rep · August 24, 2018 This report updates the 2017-18 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2017;66[No. RR-2]). Routine annual influenza vaccination is re ... Full text Link to item Cite

Randomized trial comparing the safety and antibody responses to live attenuated versus inactivated influenza vaccine when administered to breastfeeding women.

Journal Article Vaccine · July 25, 2018 BACKGROUND: Live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) are both licensed for administration to nursing mothers. Little is known about the potential for transmission of LAIV viruses from the mother to the infant and the ... Full text Link to item Cite

Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) - United States, 2018-19 Influenza Season.

Journal Article MMWR Morb Mortal Wkly Rep · June 8, 2018 Intranasally administered live attenuated influenza vaccine (LAIV) was initially licensed in the United States in 2003 as a trivalent formulation (LAIV3) (FluMist, MedImmune, LLC). Quadrivalent live attenuated influenza vaccine (LAIV4) (FluMist Quadrivalen ... Full text Link to item Cite

The effect of antipyretics on immune response and fever following receipt of inactivated influenza vaccine in young children.

Journal Article Vaccine · December 4, 2017 BACKGROUND: Antipyretics reduce fever following childhood vaccinations; after inactivated influenza vaccine (IIV) they might ameliorate fever and thereby decrease febrile seizure risk, but also possibly blunt the immune response. We assessed the effect of ... Full text Link to item Cite

Drinking Water to Prevent Postvaccination Presyncope in Adolescents: A Randomized Trial.

Journal Article Pediatrics · November 2017 BACKGROUND AND OBJECTIVES: Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduc ... Full text Link to item Cite

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2017-18 Influenza Season.

Journal Article MMWR Recomm Rep · August 25, 2017 This report updates the 2016-17 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines (MMWR Recomm Rep 2016;65[No. RR-5]). Routine annual influenza vaccination is recommended for all per ... Full text Link to item Cite

Parental Approach to the Prevention and Management of Fever and Pain Following Childhood Immunizations: A Survey Study.

Journal Article Clin Pediatr (Phila) · May 2017 Antipyretic analgesics are commonly used to prevent and treat adverse events following immunizations. Current practice discourages routine use due to possible blunting of vaccine immune responses. We surveyed 150 parents/caregivers of recently vaccinated 6 ... Full text Link to item Cite

State-Level Immunization Information Systems: Potential for Childhood Immunization Data Linkages.

Journal Article Matern Child Health J · January 2017 Objectives Sources of immunization data include state registries or immunization information systems (IIS), medical records, and surveys. Little is known about the quality of these data sources or the feasibility of using IIS data for research. We assessed ... Full text Link to item Cite

Effect of antipyretic analgesics on immune responses to vaccination.

Journal Article Hum Vaccin Immunother · September 2016 While antipyretic analgesics are widely used to ameliorate vaccine adverse reactions, their use has been associated with blunted vaccine immune responses. Our objective was to review literature evaluating the effect of antipyretic analgesics on vaccine imm ... Full text Link to item Cite

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.

Journal Article Pediatrics · February 2016 BACKGROUND AND OBJECTIVES: Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune ... Full text Link to item Cite

Cell mediated immune responses following revaccination with an influenza A/H5N1 vaccine.

Journal Article Vaccine · January 20, 2016 PURPOSE: The study aims were to determine whether inactivated influenza A/H5N1 vaccine administration elicited cell mediated immune (CMI) responses and the impact of adjuvant, vaccine dose and subject age on these responses. METHODS: Adults who were previo ... Full text Link to item Cite

Initiation & completion rates of hepatitis A vaccination among US pediatric populations born between 2005 and 2009.

Journal Article Vaccine · November 27, 2015 OBJECTIVES: To estimate hepatitis A vaccine series initiation and completion rates, assess time to vaccination, identify missed opportunities for the hepatitis A vaccine series, and examine factors associated with hepatitis A vaccine series initiation and ... Full text Link to item Cite

Safety and Immunogenicity of a Single Low Dose or High Dose of Clade 2 Influenza A(H5N1) Inactivated Vaccine in Adults Previously Primed With Clade 1 Influenza A(H5N1) Vaccine.

Journal Article J Infect Dis · August 15, 2015 Influenza A(H5N1) vaccination strategies that improve the speed of the immunological response and cross-clade protection are desired. We compared the immunogenicity of a single 15-μg or 90-μg dose of A/H5N1/Indonesia/05/05 (clade 2) vaccine in adults who w ... Full text Link to item Cite

Keen on teen vaccines: improvement of adolescent vaccine coverage in rural North Carolina.

Journal Article J Adolesc Health · May 2015 PURPOSE: To improve adolescent immunization coverage in a rural North Carolina county. METHODS: Adolescent immunization coverage rates in an intervention and four comparison counties were compared over 1 year. We introduced practice-based interventions in ... Full text Link to item Cite

Antibody responses among adolescent females receiving the quadrivalent HPV vaccine series corresponding to standard or non-standard dosing intervals.

Journal Article Vaccine · April 15, 2015 Quadrivalent human papillomavirus vaccine (HPV4) is recommended as a 3-dose series administered at 0, 1-2, and 6 months. However, this dosing schedule is often not followed leading to longer dosing intervals. We conducted a prospective study to assess anti ... Full text Link to item Cite

Pain in adolescent girls receiving human papillomavirus vaccine with concomitantly administered vaccines.

Journal Article Pediatr Infect Dis J · February 2015 Using the Faces Pain Scale - Revised, we assessed injection site pain 10 minutes after vaccination in young females randomized to receive either quadrivalent human papillomavirus vaccine (HPV4) before or after concomitantly administered vaccines. Although ... Full text Link to item Cite

Impact of body mass index on immunogenicity of pandemic H1N1 vaccine in children and adults.

Journal Article J Infect Dis · October 15, 2014 Obesity emerged as a risk factor for morbidity and mortality related to 2009 pandemic influenza A (H1N1) infection. However, few studies examine the immune responses to H1N1 vaccine among children and adults of various body mass indices (BMI). Pooling data ... Full text Link to item Cite

Immunogenicity of avian influenza A/Anhui/01/2005(H5N1) vaccine with MF59 adjuvant: a randomized clinical trial.

Journal Article JAMA · October 8, 2014 IMPORTANCE: The need to respond quickly to potential influenza pandemics is important. Immunologic priming (initial presentation of an antigen to allow antibody responses on revaccination) with vaccine directed toward an older avian influenza H5 strain mig ... Full text Link to item Cite

Immunoglobulin gene insertions and deletions in the affinity maturation of HIV-1 broadly reactive neutralizing antibodies.

Journal Article Cell Host Microbe · September 10, 2014 Induction of HIV-1 broad neutralizing antibodies (bnAbs) is a goal of HIV-1 vaccine development but has remained challenging partially due to unusual traits of bnAbs, including high somatic hypermutation (SHM) frequencies and in-frame insertions and deleti ... Full text Link to item Cite

Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP) -- United States, 2014-15 influenza season.

Journal Article MMWR Morb Mortal Wkly Rep · August 15, 2014 This report updates the 2013 recommendations by the Advisory Committee on Immunization Practices (ACIP) regarding use of seasonal influenza vaccines. Updated information for the 2014-15 influenza season includes 1) antigenic composition of U.S. seasonal in ... Link to item Cite

Clinical and immune responses to inactivated influenza A(H1N1)pdm09 vaccine in children.

Journal Article Pediatr Infect Dis J · August 2014 BACKGROUND: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immu ... Full text Link to item Cite

Human responses to influenza vaccination show seroconversion signatures and convergent antibody rearrangements.

Journal Article Cell Host Microbe · July 9, 2014 B cells produce a diverse antibody repertoire by undergoing gene rearrangements. Pathogen exposure induces the clonal expansion of B cells expressing antibodies that can bind the infectious agent. To assess human B cell responses to trivalent seasonal infl ... Full text Link to item Cite

Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.

Journal Article JAMA · May 7, 2014 IMPORTANCE: Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis. OBJECTIVE: To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effe ... Full text Link to item Cite

Engaging expectant parents to receive Tdap vaccination.

Journal Article Am J Perinatol · May 2014 OBJECTIVE: To assess the acceptability of a Tdap vaccination program for partners of pregnant women. STUDY DESIGN: Pregnant women and their partners were enrolled in a prospective acceptability study. For partners absent during the initial encounter, an in ... Full text Link to item Cite

2009 H1N1 and seasonal influenza immunization among pregnant women: a comparison of different sources of immunization information.

Journal Article Matern Child Health J · April 2014 Validity of prenatal immunization data from different sources has not been assessed. We evaluated prenatal 2009 H1N1 and seasonal influenza (FLU) data obtained from state immunization information systems (IIS), medical record abstraction (MRA), and partici ... Full text Link to item Cite

Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario.

Journal Article Vaccine · June 24, 2013 INTRODUCTION: Reintroduction of Variola major as an agent of bioterrorism remains a concern. A shortened dosing schedule of Bavarian Nordic's (BN) IMVAMUNE(®) (modified vaccinia Ankara vaccine against smallpox) was compared to the currently recommended 0- ... Full text Link to item Cite

Immunizations for preteens.

Journal Article N C Med J · 2013 As a part of health supervision visits, all preteens should receive the combined tetanus, diphtheria, and pertussis vaccine, the meningococcal conjugate vaccine, the human papillomavirus vaccine series, and an annual influenza vaccine. Because levels of va ... Link to item Cite

Phase 2 assessment of the safety and immunogenicity of two inactivated pandemic monovalent H1N1 vaccines in adults as a component of the U.S. pandemic preparedness plan in 2009.

Journal Article Vaccine · June 13, 2012 Featured Publication BACKGROUND: The influenza A/H1N1 pandemic in 2009 created an urgent need to develop vaccines for mass immunization. To guide decisions regarding the optimal immunization dosage and schedule for adults, we evaluated two monovalent, inactivated, unadjuvanted ... Full text Link to item Cite

The effectiveness of a primary care-based pediatric obesity program.

Journal Article Clin Pediatr (Phila) · April 2012 The objective of this retrospective cohort study was to evaluate the effectiveness of the Duke University Healthy Lifestyles Program (HLP), a primary care-based childhood obesity treatment program. The study population included obese 2- through 19-year-old ... Full text Link to item Cite

Healthy-days time equivalents for outcomes of acute rotavirus infections.

Journal Article Vaccine · October 19, 2011 Featured Publication Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Health-state utility measures used in economic evaluations of rotavirus vaccines do not reflect differences between mild and severe symptoms of rotavirus ... Full text Link to item Cite

Broadly neutralizing human antibody that recognizes the receptor-binding pocket of influenza virus hemagglutinin.

Journal Article Proc Natl Acad Sci U S A · August 23, 2011 Featured Publication Seasonal antigenic drift of circulating influenza virus leads to a requirement for frequent changes in vaccine composition, because exposure or vaccination elicits human antibodies with limited cross-neutralization of drifted strains. We describe a human m ... Full text Link to item Cite

Comparison of the immunogenicity and safety of a split-virion, inactivated, trivalent influenza vaccine (Fluzone®) administered by intradermal and intramuscular route in healthy adults.

Journal Article Vaccine · August 5, 2011 Featured Publication The aim of the study was to determine whether reduced doses of trivalent inactivated influenza vaccine (TIV) administered by the intradermal (ID) route generated similar immune responses to standard TIV given intramuscularly (IM) with comparable safety pro ... Full text Link to item Cite

The HPV vaccine: are dosing recommendations being followed?

Journal Article Vaccine · March 21, 2011 Featured Publication The aims of this study were to determine the percentage of females who after initiating the human papillomavirus (HPV) vaccine series, both completed it and completed it on-time, as well as to examine factors associated with series completion and on-time c ... Full text Link to item Cite

The National Children's Study in North Carolina: a study of the effect of the environment on children's health, growth, and development.

Journal Article N C Med J · 2011 Featured Publication The National Children's Study, a longitudinal cohort study exploring relationships among broadly defined environmental exposures and children's health, is assessing whether these exposures are harmful, harmless, or helpful. The study is presently underway ... Link to item Cite

H3N2 influenza infection elicits more cross-reactive and less clonally expanded anti-hemagglutinin antibodies than influenza vaccination.

Journal Article PLoS One · 2011 Featured Publication BACKGROUND: During the recent H1N1 influenza pandemic, excess morbidity and mortality was seen in young but not older adults suggesting that prior infection with influenza strains may have protected older subjects. In contrast, a history of recent seasonal ... Full text Open Access Link to item Cite

Special considerations of medication adherence in childhood and adolescence

Journal Article · December 1, 2010 Nearly all children and adolescents will at some point require medication therapy for an acute illness, usually a prescribed antibiotic or an over-the-counter medication such as acetaminophen or ibuprofen for symptomatic relief. Many children also require ... Full text Cite

Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age.

Journal Article Vaccine · November 23, 2010 Featured Publication BACKGROUND: Routine administration of quadrivalent meningococcal conjugate vaccine to adolescents and certain high risk groups is recommended in the United States and Canada. We compared the immunogenicity and safety of an investigational quadrivalent meni ... Full text Link to item Cite

Influenza vaccination of household contacts of newborns: a hospital-based strategy to increase vaccination rates.

Journal Article Infect Control Hosp Epidemiol · October 2010 Featured Publication We implemented a hospital-based influenza vaccination program for household contacts of newborns. Among mothers not vaccinated prenatally, 44.7% were vaccinated through the program, as were 25.7% of fathers. A hospital-based program provided opportunities ... Full text Open Access Link to item Cite

Trivalent inactivated influenza vaccine (TIV) immunogenicity in children 6 through 23 months of age: do children of all ages respond equally?

Journal Article Vaccine · June 17, 2010 Featured Publication We assessed the effect of age on immunogenicity to trivalent inactivated influenza vaccine (TIV) by comparing the immune responses to influenza vaccine antigens among three age cohorts of vaccine-naïve children aged 6-11 months, 12-17 months, and 18-23 mon ... Full text Link to item Cite

Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study.

Journal Article Pediatr Infect Dis J · February 2010 Featured Publication BACKGROUND: Infants less than 6 months of age are at high risk for influenza disease and influenza-related complications, but no vaccine is licensed for this population. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in 1375 he ... Full text Link to item Cite

Burden of childhood rotavirus disease on health systems in the United States.

Journal Article Pediatr Infect Dis J · February 2010 Featured Publication BACKGROUND: To determine the burden of rotavirus disease before the introduction of rotavirus vaccines. METHODS: From February 2005 to June 2006, prospective rotavirus surveillance was conducted in Cincinnati, Ohio, and Durham, North Carolina. Children < 5 ... Full text Link to item Cite

Trivalent inactivated influenza virus vaccine given to two-month-old children: an off-season pilot study.

Journal Article Pediatr Infect Dis J · December 2009 Featured Publication BACKGROUND: Although children less than 6 months of age have the highest risk for hospitalization related to influenza infection, influenza vaccine is not approved for these children. METHODS: In an open-label, off-season study, healthy 6 to 12 week and 6- ... Full text Link to item Cite

High-throughput isolation of immunoglobulin genes from single human B cells and expression as monoclonal antibodies.

Journal Article J Virol Methods · June 2009 Featured Publication Defining human B cell repertoires to viral pathogens is critical for design of vaccines that induce broadly protective antibodies to infections such as HIV-1 and influenza. Single B cell sorting and cloning of immunoglobulin (Ig) heavy- and light-chain var ... Full text Link to item Cite

The impact of rotavirus gastroenteritis on the family.

Journal Article BMC Pediatr · February 6, 2009 Featured Publication BACKGROUND: Rotavirus is the leading cause of severe diarrhea in young children and causes substantial morbidity and mortality. Although the clinical aspects have been well described, little information is available regarding the emotional, social, and eco ... Full text Link to item Cite

Cocooning infants: Tdap immunization for new parents in the pediatric office.

Journal Article Acad Pediatr · 2009 Featured Publication OBJECTIVE: Vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) is recommended for adults who have close contact with infants aged <12 months to protect young infants from infection due to Bordetella pertussis. This st ... Full text Link to item Cite

Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial.

Journal Article J Infect Dis · November 1, 2008 Featured Publication BACKGROUND: Dose-sparing strategies are being explored for vaccines against pandemic influenza. We evaluated the dose-sparing potential of aluminum hydroxide (AlOH) adjuvant. METHODS: A total of 600 healthy subjects (age, 18-49 years) were randomized to re ... Full text Link to item Cite

Large injection site reactions after a second dose of varicella vaccine.

Journal Article Pediatr Infect Dis J · August 2008 Featured Publication A second dose of varicella vaccine is routinely recommended. We report 2 cases of large local reactions after receipt of a second dose of varicella vaccine administered in the thigh. The reactions resolved with symptomatic therapy. Clinicians should contin ... Full text Link to item Cite

Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine.

Journal Article Vaccine · July 29, 2008 Featured Publication To augment the available influenza vaccine supply, a phase III study was conducted to evaluate the immunogenicity, safety, and consistency of a new trivalent inactivated influenza vaccine manufactured by CSL Limited. Healthy adults (ages 18-64) were random ... Full text Link to item Cite

Improving influenza vaccine coverage among asthmatics: A practice-based research network study

Journal Article Journal of Clinical Outcomes Management · May 1, 2008 • Objective: To evaluate an educational postcard reminder and practice improvement interventions intended to improve influenza vaccination rates among asthmatic patients. • Design: Pre-post study. • Patients and setting: Patients with asthma followed at 15 ... Cite

Low rates of adherence to 1999 acute otitis media treatment guidelines across pediatric and family practices

Journal Article Journal of Clinical Outcomes Management · November 1, 2007 • Objective: To assess adherence to 1999 guidelines for the treatment of children with acute otitis media (AOM) across primary care specialties and to measure differences across specialties and practice types. • Design: Retrospective record review. • Patie ... Cite

Safety, tolerability and immunogenicity of VAQTA given concomitantly versus nonconcomitantly with other pediatric vaccines in healthy 12-month-old children.

Journal Article Pediatr Infect Dis J · October 2006 Featured Publication BACKGROUND: The objective of this study is to assess whether hepatitis A vaccine is immunogenic and well tolerated when administered to 12-month-old children alone or concomitantly with other routinely administered pediatric vaccines. METHODS: Six hundred ... Full text Link to item Cite

Immunization with trivalent inactivated influenza vaccine in partially immunized toddlers.

Journal Article Pediatrics · September 2006 Featured Publication OBJECTIVE: Children > or = 6 months of age who have previously received 1 dose of trivalent inactivated influenza vaccine are recommended to be given an additional single trivalent inactivated influenza vaccine dose the following fall. Limited data exist d ... Full text Link to item Cite

Influenza vaccine immunogenicity in 6- to 23-month-old children: are identical antigens necessary for priming?

Journal Article Pediatrics · September 2006 Featured Publication OBJECTIVES: Immunoprophylaxis with influenza vaccine is the primary method for reducing the effect of influenza on children, and inactivated influenza vaccine has been shown to be safe and effective in children. The Advisory Committee on Immunization Pract ... Full text Link to item Cite

Tuberculosis knowledge and attitudes among physicians who treat young children in North Carolina, USA.

Journal Article Int J Tuberc Lung Dis · July 2006 SETTING: North Carolina, USA. OBJECTIVE: To understand physicians' knowledge and attitudes toward the treatment of young children with latent tuberculosis infection (LTBI) in a low-incidence region. DESIGN: Cross-sectional survey of 525 pediatricians and 5 ... Link to item Cite

Multicentre surveillance of the prevalence and molecular epidemiology of macrolide resistance among pharyngeal isolates of group A streptococci in the USA.

Journal Article J Antimicrob Chemother · June 2006 OBJECTIVES: Rates of macrolide resistance in group A streptococci (GAS) were reported to be low in the US in the 1990s. However, we documented an unexpectedly high rate of macrolide resistance among GAS in Pittsburgh, PA, in 2001 and 2002. In an effort to ... Full text Link to item Cite

Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad).

Journal Article Hum Vaccin · 2006 BACKGROUND: A combination measles, mumps, rubella, and varicella vaccine (ProQuad, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad would result in fewer injections for children and would facilitate universal immuniza ... Full text Link to item Cite

In vitro activity of telithromycin against macrolide-susceptible and macrolide-resistant pharyngeal isolates of group A streptococci in the United States.

Journal Article Antimicrob Agents Chemother · June 2005 In vitro susceptibility testing of 2,797 group A streptococcus (GAS) isolates demonstrated that telithromycin was fully active against all macrolide-susceptible strains and among 80 of 115 macrolide-resistant GAS expressing the M phenotype. Telithromycin r ... Full text Link to item Cite

A comparison of 2 influenza vaccine schedules in 6- to 23-month-old children.

Journal Article Pediatrics · April 2005 Featured Publication BACKGROUND: Trivalent inactivated influenza vaccine (TIV) is recommended for all children ages 6 to 23 months. Delivering 2 doses of TIV at least 4 weeks apart to young children receiving this vaccine for the first time is challenging. METHODS: We compared ... Full text Link to item Cite

Parents' reported preference scores for childhood atopic dermatitis disease states.

Journal Article BMC Pediatr · October 18, 2004 BACKGROUND: We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic ... Full text Link to item Cite

Psychosocial and behavioral correlates of depression among HIV-infected pregnant women.

Journal Article AIDS Patient Care STDS · July 2004 This study addressed two aims: (1) to assess the level of depressive symptoms among pregnant, HIV-infected racial and ethnic minority women and (2) to identify potentially modifiable factors associated with prenatal depression in order to foster proactive ... Full text Link to item Cite

Prescription medication sharing in primary care.

Conference JOURNAL OF GENERAL INTERNAL MEDICINE · April 1, 2004 Link to item Cite

Growth patterns reflect response to antiretroviral therapy in HIV-positive infants: potential utility in resource-poor settings.

Journal Article AIDS Patient Care STDS · January 2004 Laboratory monitoring of HIV-infected children is the current standard of care in the United States to guide the appropriate use of antiretroviral therapy (ART). Although ART is becoming a reality in some developing countries, laboratory monitoring of ART ... Full text Link to item Cite

A comparison of height and weight velocity as a part of the composite endpoint in pediatric HIV.

Journal Article AIDS · November 7, 2003 BACKGROUND: HIV adversely affects growth in children. Pediatric AIDS Clinical Trial Group (PACTG) protocols often use weight velocity [changes in weight z-score for age (WAZ)] as a part of the composite endpoint for phase II and III clinical trials. Howeve ... Full text Link to item Cite

Dual contraceptive method use for pregnancy and disease prevention among HIV-infected and HIV-uninfected women: the importance of an event-level focus for promoting safer sexual behaviors.

Journal Article Sex Transm Dis · November 2003 BACKGROUND AND OBJECTIVES: Many women who report condom use also use other methods of birth control such as oral contraceptive pills. The use of 2 or more contraceptive methods often results in less consistent condom use. GOAL: This study sought to documen ... Full text Link to item Cite

Safety, immunogenicity and efficacy in healthy infants of G1 and G2 human reassortant rotavirus vaccine in a new stabilizer/buffer liquid formulation.

Journal Article Pediatr Infect Dis J · October 2003 Featured Publication BACKGROUND: A refrigerator-stable rotavirus (RV) vaccine that withstands gastric acid is anticipated to permit more widespread use of RV vaccine. OBJECTIVE: We investigated for the first time in infants an oral, liquid formulation of G1 and G2 human bovine ... Full text Link to item Cite

Contraception use, family planning, and unprotected sex: few differences among HIV-infected and uninfected postpartum women in four US states.

Journal Article J Acquir Immune Defic Syndr · August 15, 2003 To describe pregnancy intentions and contraceptive use among a postpartum sample of women with and at risk for HIV infection, 258 HIV-seropositive and 228 HIV-seronegative women were recruited from prenatal clinics in 4 US states between June 1996-November ... Full text Link to item Cite

Palivizumab prophylaxis of respiratory syncytial virus disease in 2000-2001: results from The Palivizumab Outcomes Registry.

Journal Article Pediatr Pulmonol · June 2003 The objective of the Registry was to characterize the population of infants receiving prophylaxis for respiratory syncytial virus (RSV) disease by describing the patterns and scope of usage of palivizumab in a cross section of US infants. RSV hospitalizati ... Full text Link to item Cite

Barriers to universal prenatal HIV testing in 4 US locations in 1997.

Journal Article Am J Public Health · May 2001 OBJECTIVES: We determined rates of prenatal HIV testing and investigated barriers to testing. METHODS: We surveyed 1362 representative parturient women from 7 hospitals in 4 locations of the United States. RESULTS: Overall, 89.9% of women reported being of ... Full text Link to item Cite

Self-reported zidovudine adherence among pregnant women with human immunodeficiency virus infection in four US states.

Journal Article Am J Obstet Gynecol · May 2001 OBJECTIVE: Our purpose was to identify clinical and psychosocial factors associated with rates of prenatal zidovudine use and adherence among human immunodeficiency virus-infected pregnant women. STUDY DESIGN: Two hundred sixty-four women completed 2 inter ... Full text Link to item Cite

Partial uptake of varicella vaccine and the epidemiological effect on varicella disease in 11 day-care centers in North Carolina.

Journal Article Arch Pediatr Adolesc Med · April 2001 Featured Publication BACKGROUND: The increasing use of varicella vaccine in children attending day care has rapidly decreased the incidence of wild-type varicella disease. The herd immunity noted is significant and will have an effect on the epidemiology of natural varicella. ... Full text Link to item Cite

New mothers' knowledge and attitudes about perinatal human immunodeficiency virus infection.

Journal Article Obstet Gynecol · January 2001 OBJECTIVES: To assess new mothers' attitudes toward perinatal human immunodeficiency virus (HIV) testing, their knowledge about perinatal HIV, and their trust of government and scientists. METHODS: In a cross-sectional survey of 1362 postpartum women at fo ... Full text Link to item Cite

Infant birth weight among women with or at high risk for HIV infection: the impact of clinical, behavioral, psychosocial, and demographic factors.

Journal Article Health Psychol · November 2000 The purpose of these analyses was to provide a prospective examination of the impact of HIV on birth weight using clinical, behavioral, psychosocial, and demographic correlates. HIV-positive (n = 319) and HIV-negative (n = 220) pregnant women matched for H ... Full text Link to item Cite

Reply.

Journal Article J Infect Dis · September 2000 Full text Link to item Cite

HIV-1 infected women and prenatal care utilization: barriers and facilitators.

Journal Article AIDS Patient Care STDS · August 2000 In an effort to understand issues affecting prenatal care access and utilization from the perspectives of human immunodeficiency virus (HIV)-infected women who receive inadequate prenatal care, we conducted three in-depth qualitative and quantitative inter ... Full text Link to item Cite

Acceptance of HIV testing during prenatal care. Perinatal Guidelines Evaluation Project.

Journal Article Public Health Rep · 2000 OBJECTIVE: The purpose of this study was to assess the factors associated with acceptance of HIV testing during pregnancy on the part of women receiving prenatal care at public clinics. METHODS: Trained interviewers recruited and interviewed 1,357 women re ... Full text Link to item Cite

Postlicensure study of varicella vaccine effectiveness in a day-care setting.

Journal Article Pediatr Infect Dis J · December 1999 Featured Publication BACKGROUND: Varicella vaccine has been licensed for use in the United States since the spring of 1995. The acceptance of the vaccine and its effect on varicella incidence in children is important. AIM: To document the effectiveness of the varicella vaccine ... Full text Link to item Cite

Interference of antibody production to hepatitis B surface antigen in a combination hepatitis A/hepatitis B vaccine.

Journal Article J Infect Dis · December 1999 A randomized trial comparing 3 manufacturing consistency lots of a combination hepatitis A/hepatitis B vaccine to each other and to hepatitis A vaccine and hepatitis B vaccine given separately and concurrently was done to evaluate safety, tolerability, and ... Full text Link to item Cite

Concurrent administration of inactivated hepatitis A vaccine with immune globulin in healthy adults.

Journal Article Vaccine · March 17, 1999 Featured Publication 301 healthy adult volunteers were randomized to one of three treatment groups: inactivated hepatitis A vaccine alone; inactivated hepatitis A vaccine with immune globulin (Ig) concurrently; or Ig alone. The first two treatment groups received a second dose ... Full text Link to item Cite

Varicella vaccination in a primary care pediatric practice.

Journal Article Arch Pediatr Adolesc Med · June 1998 Link to item Cite

Over five-year follow-up of Oka/Merck varicella vaccine recipients in 465 infants and adolescents.

Journal Article Pediatr Infect Dis J · October 1995 Featured Publication A total of 465 healthy infants and adolescents ages 12 months to 17 years without a known history of varicella or recent exposure to varicella-zoster virus VZV were immunized with live attenuated Oka/Merck varicella vaccine from November, 1984, through Apr ... Full text Link to item Cite

Influenza A vaccine decreases the incidence of otitis media in 6- to 30-month-old children in day care.

Journal Article Arch Pediatr Adolesc Med · October 1995 Featured Publication OBJECTIVE: To determine if the use of influenza vaccine in children in day care decreases the incidence of otitis media during the influenza season. DESIGN: Prospective cohort study. SETTING: Eight day-care centers in North Carolina. PARTICIPANTS: One hund ... Full text Link to item Cite

Varicella prevalence in day-care centers.

Journal Article Pediatr Infect Dis J · May 1995 Full text Link to item Cite

Maternal acceptance of voluntary human immunodeficiency virus antibody testing during the newborn period with the Guthrie card.

Journal Article Pediatr Infect Dis J · May 1995 In order to provide the opportunity for women delivering newborns to have human immunodeficiency virus (HIV) testing we piloted a hospital-based voluntary HIV testing program during the newborn period using the Guthrie card. During the study period 789 wom ... Full text Link to item Cite

Measles immunity in HIV-infected children.

Journal Article Pediatr AIDS HIV Infect · October 1994 In a retrospective study, sera from 84 children of human immunodeficiency virus (HIV)-seropositive mothers (35 HIV-infected and 49 uninfected children) with a known date of receipt of measles, mumps, and rubella vaccine were tested for antibody to measles ... Link to item Cite

Identifying human immunodeficiency virus infection at birth: application of polymerase chain reaction to Guthrie cards.

Journal Article J Pediatr · August 1993 Guthrie cards containing dried blood spots from 67 children now known to be infected with human immunodeficiency virus (HIV) and 63 children now classified as having had seroreversion were retrieved from the newborn infant archives from 1986 through 1991 t ... Full text Link to item Cite

HIV-1 sensitivity to zidovudine and clinical outcome in children.

Journal Article Lancet · January 4, 1992 In adults with the acquired immunodeficiency syndrome, long-term monotherapy with zidovudine selects for human immunodeficiency virus type 1 (HIV-1) strains with substantially reduced in-vitro susceptibility to the drug. We have assessed the relation betwe ... Full text Link to item Cite

Immunogenicity of Haemophilus b conjugate vaccine (meningococcal protein conjugate) in children with prior invasive Haemophilus influenzae type b disease.

Journal Article Pediatr Infect Dis J · September 1990 Children younger than 2 years of age with previous invasive Haemophilus influenzae (Hib) type b disease may not develop protective antibodies to antigens of Hib and may be at risk of developing a second episode of Hib disease. Twenty-three children with pr ... Link to item Cite

Systemic Torulopsis glabrata infection in a neonate.

Journal Article South Med J · July 1990 We have reported a case of neonatal Torulopsis glabrata peritonitis and ventriculitis associated with a ventriculoperitoneal shunt. Treatment of fungemia and ventriculitis with amphotericin B and 5-fluorocytosine was successful. ... Full text Link to item Cite

Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group.

Journal Article J Pediatr · April 1990 Thirty-five children with symptomatic human immunodeficiency virus infection were enrolled in a 12-week, three-center phase I study of intravenous and oral zidovudine therapy. At enrollment the children ranged in age from 5 months to 13 years, with a media ... Full text Link to item Cite