Journal ArticleAIDS Res Hum Retroviruses · November 2024
The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability ...
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Journal ArticleViruses · 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 ...
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Journal ArticleEBioMedicine · 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 ...
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Journal ArticleScience 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 ...
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Journal ArticleFront 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 ...
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Journal ArticleJ Infect Dis · August 24, 2022
BACKGROUND: The ALVAC/gp120 + MF59 vaccines in the HIV Vaccine Trials Network (HVTN) 702 efficacy trial did not prevent human immunodeficiency virus-1 (HIV-1) acquisition. Vaccine-matched immunological endpoints that were correlates of HIV-1 acquisition ri ...
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Journal ArticleScience · January 7, 2022
In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time o ...
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Journal ArticleScientific reports · December 2021
Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudoviru ...
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Journal ArticlemedRxiv · September 14, 2021
Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States Government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudoviru ...
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Journal ArticlemedRxiv · August 15, 2021
BACKGROUND: In the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection. MET ...
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Journal ArticleClin Infect Dis · January 23, 2021
BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immuno ...
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Journal ArticleFront Immunol · 2021
The outcome of the recent Antibody Mediated Prevention (AMP) trials that tested infusion of the broadly neutralizing antibody (bnAb) VRC01 provides proof of concept for blocking infection from sensitive HIV-1 strains. These results also open up the possibi ...
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Journal ArticleJ Immunol Methods · April 2020
The recent identification of human monoclonal antibodies with broad and potent neutralizing activity against HIV-1 (bnAbs) has resulted in substantial efforts to develop these molecules for clinical use in the prevention and treatment of HIV-1 infection. A ...
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Journal ArticleJ Immunol Methods · April 2020
The ability to detect, quantify, and interrogate the properties of immune responses raised against biological therapeutics is not only important to our understanding of these molecules, but also to their success in the clinic. A tiered assay approach to id ...
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Journal ArticleAccount Res · July 2019
Academic medical centers rarely require all of their research faculty and staff to participate in educational programs on the responsible conduct of research (RCR). There is also little published evidence of RCR programs addressing high-profile, internal c ...
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Journal ArticleJ Immunol · August 15, 2018
Ab avidity is a measure of the overall strength of Ab-Ag interactions and hence is important for understanding the functional efficiency of Abs. In vaccine evaluations, Ab avidity measurements can provide insights into immune correlates of protection and g ...
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Journal ArticleLancet HIV · July 2018
BACKGROUND: Modest efficacy was reported for the HIV vaccine tested in the RV144 trial, which comprised a canarypox vector (ALVAC) and envelope (env) glycoprotein (gp120). These vaccine components were adapted to express HIV-1 antigens from strains circula ...
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Journal ArticleJ Immunol Methods · April 2018
The Fc Array is a multiplexed assay that assesses the Fc domain characteristics of antigen-specific antibodies with the potential to evaluate up to 500 antigen specificities simultaneously. Antigen-specific antibodies are captured on antigen-conjugated bea ...
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Journal ArticleJ Infect Dis · March 28, 2018
BACKGROUND: HVTN 505 was a human immunodeficiency virus type 1 (HIV-1) preventive vaccine efficacy trial of a DNA/recombinant adenovirus serotype 5 (rAd5) vaccine regimen. We assessed antibody responses measured 1 month after final vaccination (month 7) as ...
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Journal ArticlePLoS One · 2018
The standardized assessments of HIV-specific immune responses are of main interest in the preclinical and clinical stage of HIV-1 vaccine development. In this regard, HIV-1 Env-pseudotyped viruses play a central role for the evaluation of neutralizing anti ...
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Journal ArticleSci Rep · April 7, 2017
Characterizing neutralizing antibody (NAb) responses in individuals infected with diverse HIV-1 strains is necessary to reveal the novel targets for regional preventive and therapeutic strategies development. We evaluated the prevalence, breadth, and poten ...
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Journal ArticleJ Clin Invest · July 1, 2015
Despite the wide availability of antiretroviral drugs, more than 250,000 infants are vertically infected with HIV-1 annually, emphasizing the need for additional interventions to eliminate pediatric HIV-1 infections. Here, we aimed to define humoral immune ...
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Journal ArticleJ Immunol Methods · July 2014
The TZM-bl assay measures antibody-mediated neutralization of HIV-1 as a function of reductions in HIV-1 Tat-regulated firefly luciferase (Luc) reporter gene expression after a single round of infection with Env-pseudotyped viruses. This assay has become t ...
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Journal ArticleJ Immunol Methods · July 2014
A3R5 is a human CD4(+) lymphoblastoid cell line that was engineered to express CCR5 and is useful for the detection of weak neutralizing antibody responses against tier 2 strains of HIV-1. Here we describe the optimization and validation of the HIV-1 neutr ...
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Journal ArticleJ Immunol Methods · July 2014
The interferon-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay has been developed and used as an end-point assay in clinical trials for infectious diseases and cancer to detect the magnitude of antigen-specific immune responses. The ability to compare ...
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Journal ArticleJ Immunol Methods · July 2014
The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV pro ...
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Journal ArticleJ Immunol Methods · July 2014
The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cult ...
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Journal ArticleJ Virol · March 2014
UNLABELLED: Standardized assessments of HIV-1 vaccine-elicited neutralizing antibody responses are complicated by the genetic and antigenic variability of the viral envelope glycoproteins (Envs). To address these issues, suitable reference strains are need ...
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Journal ArticleJournal of Immunological Methods · January 1, 2014
The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cult ...
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Journal ArticleJ Clin Immunol · January 2013
PURPOSE: Severe combined immunodeficiency (SCID) is a syndrome of diverse genetic cause characterized by profound deficiencies of T, B and sometimes NK cell function. Non-ablative HLA-identical or rigorously T cell-depleted haploidentical parental bone mar ...
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Journal ArticleJ Gen Virol · October 2012
Broadly neutralizing antibodies (NAbs) such as those generated in chronic human immunodeficiency virus type 1 (HIV-1) infection are considered a key component for an effective HIV-1 vaccine. Here, we measured NAb responses using a panel of 25 Env-pseudotyp ...
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Journal ArticleJ Virol · April 2012
HIV-exposed, uninfected (EUN) babies born to HIV-infected mothers are examples of natural resistance to HIV infection. In this study, we evaluated the titer and neutralizing potential of gp41-specific maternal antibodies and their correlation with HIV tran ...
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Journal ArticleJ Immunol Methods · January 31, 2012
Recent advances in assay technology have led to major improvements in how HIV-1 neutralizing antibodies are measured. A luciferase reporter gene assay performed in TZM-bl (JC53bl-13) cells has been optimized and validated. Because this assay has been adopt ...
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Journal ArticlePLoS One · 2012
BACKGROUND: Infections with HIV still represent a major human health problem worldwide and a vaccine is the only long-term option to fight efficiently against this virus. Standardized assessments of HIV-specific immune responses in vaccine trials are essen ...
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Journal ArticlePLoS One · 2012
The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody-Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compli ...
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Journal ArticleImmunol Res · April 2011
Telomeres are noncoding DNA regions at the end of the chromosomes that are crucial for genome stability. Since telomere length decreases with cell division, they can be used as a signature of cell proliferation history. T-cell reconstitution in severe comb ...
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Journal ArticleBlood · August 13, 2009
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Severe combined immunodeficiency (SCID) is a syndrome of diverse genetic cause characterized by profound deficiencies of T, B, and sometimes NK-cell function. Nonablative human leukocyte antigen-identical or rigorously T cell-depleted haploidentical parent ...
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Journal ArticlePLoS Med · May 26, 2009
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Marcella Sarzotti-Kelsoe and colleagues harmonize various approaches to Good Clinical Laboratory Practice for clinical trials into a single set of recommendations. ...
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Chapter · April 8, 2008
An HIV-1 vaccine is the best public health tool for stemming the AIDS pandemic, now in its third decade. Studies from HIV-1 infected humans who control infection, animal model experiments, as well as historic experience with licensed vaccines suggest that ...
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Journal ArticleBlood · May 15, 2007
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The purpose of this study was to characterize a large group of infants with complete DiGeorge anomaly and to evaluate the ability of thymus transplantation to reconstitute immune function in these infants. DiGeorge anomaly is characterized by varying defec ...
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Journal ArticleBlood · April 15, 2007
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CD3zeta is a subunit of the T-cell antigen receptor (TCR) complex required for its assembly and surface expression that also plays an important role in TCR-mediated signal transduction. We report here a patient with T(-)B(+)NK(+) severe combined immunodefi ...
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Journal ArticleInt Immunol · February 2006
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Immunizations early in life, when the host is most susceptible to infection, allow protective immunological memory to develop. Decreasing the dose of Cas-Br-E murine leukemia virus when priming neonatal mice results in adult-like, Type 1 protective respons ...
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Journal ArticleBioinformatics · September 15, 2005
SUMMARY: SpA is a web-accessible system for the management, visualization and statistical analysis of T-cell receptor spectratype data. Users upload data from their spectratype analyzers to SpA, which saves the raw data and user-defined supplementary covar ...
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Journal ArticleBioinformatics · August 15, 2005
MOTIVATION: The effectiveness of vertebrate adaptive immunity depends crucially on the establishment and maintenance of extreme diversity in the antigen receptor repertoire. Spectratype analysis is a method used in clinical and basic immunological settings ...
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Journal ArticleBlood · October 15, 2004
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Complete DiGeorge syndrome is a fatal congenital disorder characterized by athymia, hypoparathyroidism, and heart defects. Less than half of patients are 22q11 hemizygous. The goal of this study was to assess if immune suppression followed by postnatal thy ...
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Journal ArticleJ Immunol · April 1, 2004
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Glucose-regulated protein 94 (GRP94/gp96), the endoplasmic reticulum heat shock protein 90 paralog, elicits both innate and adaptive immune responses. Regarding the former, GRP94/gp96 stimulates APC cytokine expression and dendritic cell maturation. The ad ...
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Journal ArticleJ Allergy Clin Immunol · April 2004
BACKGROUND: Five patients with DiGeorge syndrome presented with infections, skin rashes, and lymphadenopathy after the newborn period. T-cell counts and function varied greatly in each patient. Initial laboratory testing did not suggest athymia in these pa ...
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Journal ArticleBlood · August 1, 2003
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Complete DiGeorge syndrome is a fatal condition in which infants have no detectable thymus function. The optimal treatment for the immune deficiency of complete DiGeorge syndrome has not been determined. Safety and efficacy of thymus transplantation were e ...
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Journal ArticleJ Immunol · March 1, 2003
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Transplantation of HLA-identical or haploidentical T cell-depleted allogeneic bone marrow (BM) into SCID infants results in thymus-dependent T cell development in the recipients. Immunoscope analysis of the TCR V beta repertoire was performed on 15 SCID pa ...
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Journal ArticleJ Exp Med · December 2, 2002
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In chemical carcinogenesis models, GRP94 (gp96) elicits tumor-specific protective immunity. The tumor specificity of this response is thought to reflect immune responses to GRP94-bound peptide antigens, the cohort of which uniquely identifies the GRP94 tis ...
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Journal ArticleJ Immunol · September 15, 2002
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The goal of infant immunization against viral infection is to develop protective long term memory responses. Priming neonatal mice with a low dose of Cas-Br-E murine leukemia virus (Cas) results in adult-like, type 1 protective responses. However, other st ...
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Journal ArticleInt Immunol · January 2001
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We have identified a small subset of CD3(+), CD4(+), CD8(-) thymocytes that do not express Thy1 (CD90). This Thy1(-) subset represents 1-3.7% of the total number of thymocytes in a naive mouse. CD4(+)Thy1(-) thymocytes express high levels of CD3, intermedi ...
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Journal ArticleInfect Immun · April 2000
We tested the hypothesis that gammadelta T cells are a component of an early immune response directed against preerythrocytic malaria parasites that are required for the induction of an effector alphabeta T-cell immune response generated by irradiated-spor ...
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Journal ArticleImmunol Res · 2000
Typically, neonates exhibit decreased or aberrant cellular immune responses when compared to adults, resulting in increased susceptibility to infection. However, it is clear that newborns are able to generate adult-like protective T cell responses under ce ...
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Journal ArticleInt Rev Immunol · 2000
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Reduced numbers of lymphocytes and antigen presenting cells have been described as some of the main factors responsible for antigenic tolerance or low responsiveness in neonates. However, by changing the parameters of immunization, such as dose of antigen ...
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Journal ArticleVaccine · 1998
DNA immunization is a relatively new and efficacious approach to vaccination. Only recently have we begun to test the efficacy of DNA vaccines in infants. DNA vaccines for a retrovirus, hepatitis B, influenza, rabies, measles, tetanus toxoid, and sendai vi ...
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Journal ArticleVaccine · June 1997
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Cytotoxic T cells (CTL) play a critical role in controlling viral infections. Infection of neonatal NFSIN mice with a high dose of Cas-Br-M murine leukemia virus, a neuropathogenic type C retrovirus, results in virus-induced neurologic disease and in their ...
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Journal ArticleCurr Opin Hematol · January 1997
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Understanding the phenomenon of immunologic tolerance and the mechanisms that control it at different stages of lymphocyte development is rapidly progressing. This review summarizes some recent findings in T-cell tolerance, focusing on neonatal and periphe ...
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Journal ArticleScience · March 22, 1996
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The susceptibility of neonates to virus-induced disease is thought to reflect, in part, the immaturity of their immune systems. However, inoculation of newborn mice with low doses of Cas-Br-M murine leukemia virus induced a protective cytotoxic T lymphocyt ...
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Journal ArticleImmunology · March 1996
Spleen cells from mice resistant or sensitive to mouse acquired immune deficiency syndrome (MAIDS) were examined for cytokine mRNA. In MAIDS-resistant BALB/c mice, cytokine transcripts peaked at 1 week after infection with Type 1 cytokines [interleukin-2 ( ...
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Journal ArticleJ Virol · November 1995
Previous studies of Cas-Br-M murine leukemia virus (MuLV) (Cas-MuLV) infection demonstrated that cytotoxic T cells (CTL) of the CD8+ phenotype play a role in resistance to the neuropathogenic effects of the virus in NFS/N mice. In the current study, we sou ...
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Journal ArticleAm J Trop Med Hyg · January 1995
Finding an effective treatment for viral infections that cause encephalitis remains an important problem. A model of human alphavirus infections, Semliki Forest virus, causes lethal encephalitis in weanling mice. Mice are viremic within 24 hr of an intrape ...
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Journal ArticleAIDS Res Hum Retroviruses · December 1994
Newborn NFS/N mice are susceptible to the neurological disease induced by infection with Cas-Br-M murine leukemia virus (Cas), and do not develop a protective cytotoxic T cell (CTL)-mediated response to Cas infection. Here we demonstrate that whole UV ligh ...
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Journal ArticleViral Immunol · 1993
T cell-mediated production of IFN-gamma followed infection of adult, but not neonatal NFS/N mice with Cas-Br-M murine leukemia virus (Cas). The IFN-gamma response was associated with the appearance of CTL specific for Cas and with age-dependent resistance ...
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Journal ArticleEur J Immunol · March 1991
Discrete colonies of splenocytes were grown on filter paper discs in the presence of concanavalin A and interleukin 2. Phenotypic analysis of the colonies indicated that the majority expressed the Thy-1.2 marker and 72% of these co-expressed the CD3 molecu ...
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Journal ArticleAntimicrob Agents Chemother · December 1989
Most antiviral agents are efficacious prophylactically in vivo, and a few are efficacious for postinfection (p.i.) therapy. To explore possibilities for p.i. therapy of encephalogenic Banzi virus (BZV) and Semliki Forest virus infections in mice, we evalua ...
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Journal ArticleJ Interferon Res · June 1989
An interferon (IFN) inducer and immunomodulator, CL246,738 [3,6-bis(2-piperidinoethoxy)acridine trihydrochloride], protected mice from lethal infection with Semliki Forest (SFV) and Banzi (BZV) viruses. A single oral dose of CL246,738 (5-150 mg/kg) adminis ...
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Journal ArticleNat Immun Cell Growth Regul · 1989
The sensitivity of target cells to natural killer (NK) cell-mediated cytotoxicity was investigated. Five target cell lines were examined for susceptibility to killing by activated NK cells in a 4-hour cytotoxicity assay: one of them (K562) was highly sensi ...
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Journal ArticleMol Biother · 1989
These studies provide the first evidence that adoptive transfer of syngeneic mouse (BALB/c) lymphocytes treated with low levels of mouse interferon (IFN)-alpha/beta can result in sufficient protection to protect mice from Semliki Forest virus (SFV) infecti ...
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Journal ArticleInt J Cancer · January 15, 1987
The relationship between metastatic cells in the spleen and bone marrow of tumor-bearing mice and the NK activity generated in vitro by cells obtained from these organs was investigated. EL-4 lymphoma and B16 melanoma cells injected intraperitoneally into ...
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Journal ArticleCell Immunol · June 1986
Corynebacterium parvum-activated macrophages (M phi), purified by adherence, were cytotoxic for B16 melanoma cells maintained in vitro. Pretreatment of the melanoma cells for 18 hr with interferon-alpha/beta or -gamma (IFN-alpha/beta or -gamma) caused a re ...
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Journal ArticleCell Immunol · April 15, 1985
Bone marrow cells cultured for 5-6 days generate cytotoxic activity against a number of natural killer (NK)-susceptible tumor cells. In this study, these bone marrow cytotoxic cells were compared to cells with NK activity obtained either from spleen cells ...
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Journal ArticleInfect Immun · August 1983
Macromolecular synthesis of immune interferon (IFN-gamma) by the L12-R4 T cell lymphoma, stimulated by phorbol myristic acetate, was studied by using reversible inhibitors of protein synthesis, puromycin and cycloheximide, and an irreversible inhibitor of ...
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Journal ArticleJ Immunogenet · June 1983
The features of the immune recognition of a murine fibrosarcoma induced by Rous sarcoma virus were tested in histocompatible and histoincompatible mice. No evidence of a genetic regulation of spontaneous reactivity to tumour-associated antigens was found i ...
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Journal ArticleMicrobiologica · April 1983
Mouse immune interferon was produced from a T-lymphoma cell line, L12-R4, upon stimulation with phorbol myristic acetate at a concentration of 2 x 10(-7) M/ml. The crude interferon, concentrated by precipitation with (NH4)2SO4 at concentration of 80%, was ...
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Journal ArticleBoll Ist Sieroter Milan · 1982
Spleen cells from DBA/2 mice did not proliferate, but released interferon (IFN) when cultured in the presence of mitomycin C-treated syngeneic L1210 leukemia cells apparently free from mycoplasma and common non-oncogenic viral infections. IFN titers reache ...
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