Evidence map›Paper›PMID 25090110›Full record

Trial reportPloS one2014

Predictors of HVTN 503 MRK-AD5 HIV-1 gag/pol/nef vaccine induced immune responses.

Kathryn L Hopkins, Fatima Laher, Kennedy Otwombe, Gavin Churchyard, Linda-Gail Bekker, Stephen DeRosa, Maphoshane Nchabeleng, Koleka Mlisana, James Kublin, Glenda Gray

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Kathryn L HopkinsPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Fatima LaherPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Kennedy OtwombePerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Gavin ChurchyardAurum Institute for Health Research, Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
Linda-Gail BekkerDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Stephen DeRosaHIV Vaccine Trials Network, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Maphoshane NchabelengMedunsa HIV Clinical Research Unit, University of Limpopo, Pretoria, South Africa.
Koleka MlisanaCentre for AIDS Programme for Research in South Africa & Department of Medical Microbiology, University of KwaZulu-Natal, Durban, South Africa.
James KublinHIV Vaccine Trials Network, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Glenda GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
Leadership Group for a Global HIV Vaccine Clinical Trials NetworkU01AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 2006 to 2010
$181.5M
HVTN Laboratory ProgramU01AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2006 to 2010
$82.6M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Vaccine Trials NetworkU01AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI SELF, STEVEN G. · 2006 to 2010
$53.8M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
University of Cape Town Clinical Trials Unit (UCTCTU)UM1AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI Linda-Gail Bekker · 2012 to 2026
$36.3M
University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitU01AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI ABDOOL KARIM, SALIM S · 2007 to 2011
$28.0M
Soweto Clinical Trials UnitU01AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI GRAY, GLENDA · 2007 to 2011
$25.5M
Cape Town Clinical Trials Unit (CT-CTU) for HIV/AIDS Prevention & TreatmentU01AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI WOOD, ROBIN · 2007 to 2011
$4.6M
South Africa Tuberculosis/AIDS TrainingU2RTW007373 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VAN DER HORST, CHARLES MICHAEL · 2007 to 2012
$1.4M
FIC NIH HHS TW007373/0NIAID NIH HHS 5U01 AI068614NIAID NIH HHS 5U01 AI068618NIAID NIH HHS 5U01 AI068635NIAID NIH HHS 5U01 AI069453NIAID NIH HHS 5U01 AI069469NIAID NIH HHS 5U01 AI069519NIAID NIH HHS U01 AI068614NIAID NIH HHS U01 AI068618NIAID NIH HHS U01 AI068635NIAID NIH HHS U01 AI069453NIAID NIH HHS U01 AI069469NIAID NIH HHS U01 AI069519NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069519
6 · The paper itself

Abstract

backgroundPhambili, the Merck (MRK)-Adenovirus Type 5 (Ad5) HIV-1 gag/pol/nef subtype B vaccine study, conducted in South Africa, suspended enrollment and vaccination when companion study, Step, was found non-efficacious. Although the vaccine did not prevent HIV-1 infection or lower viral-load setpoint, immune responses recognized clades B and C HIV-1 subtypes. We investigated predictors of the vaccine-induced antigen-specific immune responses.

methodsVaccine-induced immunogenicity was ascertained by interferon-γ ELISpot assays on the first 186 enrolled participants receiving two vaccinations. Analyses, stratified by study arm/sex, were performed on baseline demographics [sex, age, Body Mass Index (BMI), site, Adenovirus Type-5 (Ad5) titer, Herpes Simplex Virus Type-2 (HSV2) status, heavy drinking]. Multivariate logistic regression determined predictors.

resultsOf the 186 participants, 53.7% (n = 100) were female, median BMI was 22.5 [IQR: 20.4-27.0], 85.5% (n = 159) were Ad5 seropositive, and 18.8% (n = 35) drank heavily. All vaccine recipients responded to both clade B (n = 87; 47%) and/or C (n = 74; 40%), p = 0.17. In multivariate analysis, female sex [Adjusted Odds Ratio (AOR): 6.478; p = 0.0159], overweight/obese BMI (AOR: 0.186; p = 0.0452), and heavy drinking (AOR: 0.270; p = 0.048) significantly predicted immune response to clade C for any antigens. A marginally significant predictor of clade C-pol antigen was female sex (AOR: 3.182; p = 0.0500).

conclusionsSex, BMI, and heavy drinking affected vaccine-induced HIV-1 specific immune responses to clade C antigens. The role of female sex and overweight/obese BMI boosting and suppressing vaccine-induced HIV-1 specific immune responses, respectively, requires elucidation, including any effect on HIV vaccine efficacy, especially in the era of colliding epidemics (HIV and obesity).

Indexed as

AdenoviridaeAIDS VaccinesDemographyEnzyme-Linked Immunospot AssayFemalegag Gene Products, Human Immunodeficiency VirusHIV AntigensHIV InfectionsHumansMaleMultivariate Analysisnef Gene Products, Human Immunodeficiency Viruspol Gene Products, Human Immunodeficiency VirusYoung AdultAIDS Vaccinesgag Gene Products, Human Immunodeficiency VirusHIV Antigensnef Gene Products, Human Immunodeficiency Viruspol Gene Products, Human Immunodeficiency Virus

Identifiers

PMID25090110
PMCPMC4121165

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.