Scholars@Duke
Avi Kenny

Avi Kenny CV

Assistant Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
avi.kenny@duke.edu
Box 90519, Durham, NC 27708
310 Trent Drive, Durham, NC 27708
CV

Selected Publications

Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control study.

Journal Article EBioMedicine · October 2024 BACKGROUND: The HVTN 705 Imbokodo trial of 2636 people without HIV and assigned female sex at birth, conducted in southern Africa, evaluated a heterologous HIV-1 vaccine regimen: mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) at Months 0, 3, 6, 12 and ... Full text Link to item Cite

Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial.

Journal Article Nat Commun · September 11, 2024 In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-Co ... Full text Link to item Cite

Robust analysis of stepped wedge trials using composite likelihood models.

Journal Article Stat Med · July 30, 2024 Stepped wedge trials (SWTs) are a type of cluster randomized trial that involve repeated measures on clusters and design-induced confounding between time and treatment. Although mixed models are commonly used to analyze SWTs, they are susceptible to misspe ... Full text Link to item Cite

Four statistical frameworks for assessing an immune correlate of protection (surrogate endpoint) from a randomized, controlled, vaccine efficacy trial.

Journal Article Vaccine · April 2, 2024 A central goal of vaccine research is to characterize and validate immune correlates of protection (CoPs). In addition to helping elucidate immunological mechanisms, a CoP can serve as a valid surrogate endpoint for an infectious disease clinical outcome a ... Full text Link to item Cite

Under-five mortality before and after implementation of the Liberia National Community Health Assistant (NCHA) program: A study protocol.

Journal Article PLoS One · 2024 Between 2018 and 2022 the Liberian Government implemented the National Community Health Assistant (NCHA) program to improve provision of maternal and child health care to underserved rural areas of the country. Whereas the contributions of this and similar ... Full text Link to item Cite

A controlled effects approach to assessing immune correlates of protection.

Journal Article Biostatistics · October 18, 2023 An immune correlate of risk (CoR) is an immunologic biomarker in vaccine recipients associated with an infectious disease clinical endpoint. An immune correlate of protection (CoP) is a CoR that can be used to reliably predict vaccine efficacy (VE) against ... Full text Link to item Cite

Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial.

Journal Article Viruses · September 29, 2023 The COVE trial randomized participants to receive two doses of mRNA-1273 vaccine or placebo on Days 1 and 29 (D1, D29). Anti-SARS-CoV-2 Spike IgG binding antibodies (bAbs), anti-receptor binding domain IgG bAbs, 50% inhibitory dilution neutralizing antibod ... Full text Link to item Cite

Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.

Journal Article EBioMedicine · July 2023 BACKGROUND: The phase 2b proof-of-concept Antibody Mediated Prevention (AMP) trials showed that VRC01, an anti-HIV-1 broadly neutralising antibody (bnAb), prevented acquisition of HIV-1 sensitive to VRC01. To inform future study design and dosing regimen s ... Full text Link to item Cite

Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial.

Journal Article Science translational medicine · April 2023 The best assay or marker to define mRNA-1273 vaccine-induced antibodies as a correlate of protection (CoP) is unclear. In the COVE trial, participants received two doses of the mRNA-1273 COVID-19 vaccine or placebo. We previously assessed IgG binding antib ... Full text Cite

Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.

Journal Article Nat Microbiol · December 2022 Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of ... Full text Link to item Cite

Analysis of stepped wedge cluster randomized trials in the presence of a time-varying treatment effect.

Journal Article Stat Med · September 30, 2022 Stepped wedge cluster randomized controlled trials are typically analyzed using models that assume the full effect of the treatment is achieved instantaneously. We provide an analytical framework for scenarios in which the treatment effect varies as a func ... Full text Link to item Cite

Random effect misspecification in stepped wedge designs.

Journal Article Clin Trials · August 2022 Stepped wedge cluster randomized trials are often analysed using linear mixed effects models that may include random effects for cluster, time and/or treatment. We investigate the impact of misspecification of the random effects structure of the model. Spe ... Full text Link to item Cite

Model misspecification in stepped wedge trials: Random effects for time or treatment.

Journal Article Stat Med · May 10, 2022 Mixed models are commonly used to analyze stepped wedge trials (SWTs) to account for clustering and repeated measures on clusters. One critical issue researchers face is whether to include a random time effect or a random treatment effect. When the wrong m ... Full text Link to item Cite

Immune correlates analysis of the Imbokodo HIV-1 vaccine efficacy trial

Conference JOURNAL OF THE INTERNATIONAL AIDS SOCIETY · 2022 Cite

Measuring Knowledge of Community Health Workers at the Last Mile in Liberia: Feasibility and Results of Clinical Vignette Assessments.

Journal Article Glob Health Sci Pract · March 15, 2021 INTRODUCTION: Community health workers (CHWs) can provide lifesaving treatment for children in remote areas, but high-quality care is essential for effective delivery. Measuring the quality of community-based care in remote areas is logistically challengin ... Full text Link to item Cite

Design and implementation of a mobile health electronic data capture platform that functions in fully-disconnected settings: a pilot study in rural Liberia.

Journal Article BMC Med Inform Decis Mak · February 22, 2020 BACKGROUND: Mobile phones and personal digital assistants have been used for data collection in developing world settings for over three decades, and have become increasingly common. However, the use of electronic data capture (EDC) through mobile phones i ... Full text Link to item Cite

Satellite images and machine learning can identify remote communities to facilitate access to health services.

Journal Article J Am Med Inform Assoc · August 1, 2019 OBJECTIVE: Community health systems operating in remote areas require accurate information about where people live to efficiently provide services across large regions. We sought to determine whether a machine learning analyses of satellite imagery can be ... Full text Link to item Cite

A Community Health Worker Intervention to Increase Childhood Disease Treatment Coverage in Rural Liberia: A Controlled Before-and-After Evaluation.

Journal Article Am J Public Health · September 2018 OBJECTIVES: To assess a community health worker (CHW) program's impact on childhood illness treatment in rural Liberia. METHODS: We deployed CHWs in half of Rivercess County in August 2015 with the other half constituting a comparison group until July 2016 ... Full text Link to item Cite

Validation Relaxation: A Quality Assurance Strategy for Electronic Data Collection.

Journal Article J Med Internet Res · August 18, 2017 BACKGROUND: The use of mobile devices for data collection in developing world settings is becoming increasingly common and may offer advantages in data collection quality and efficiency relative to paper-based methods. However, mobile data collection syste ... Full text Link to item Cite

Implementation research on community health workers' provision of maternal and child health services in rural Liberia.

Journal Article Bull World Health Organ · February 1, 2017 OBJECTIVE: To assess changes in the use of essential maternal and child health services in Konobo, Liberia, after implementation of an enhanced community health worker (CHW) programme. METHODS: The Liberian Ministry of Health partnered with Last Mile Healt ... Full text Link to item Cite

Charting health system reconstruction in post-war Liberia: a comparison of rural vs. remote healthcare utilization.

Journal Article BMC Health Serv Res · September 7, 2016 BACKGROUND: Despite a growing global emphasis on universal healthcare, access to basic primary care for remote populations in post-conflict countries remains a challenge. To better understand health sector recovery in post-conflict Liberia, this paper seek ... Full text Link to item Cite

Facility-Based Delivery during the Ebola Virus Disease Epidemic in Rural Liberia: Analysis from a Cross-Sectional, Population-Based Household Survey.

Journal Article PLoS Med · August 2016 BACKGROUND: The Ebola virus disease (EVD) epidemic has threatened access to basic health services through facility closures, resource diversion, and decreased demand due to community fear and distrust. While modeling studies have attempted to estimate the ... Full text Link to item Cite

Remoteness and maternal and child health service utilization in rural Liberia: A population-based survey.

Journal Article J Glob Health · December 2015 BACKGROUND: This study seeks to understand distance from health facilities as a barrier to maternal and child health service uptake within a rural Liberian population. Better understanding the relationship between distance from health facilities and rural ... Full text Link to item Cite