Evidence map›Paper›PMID 35758878›Full record

Trial reportThe Journal of infectious diseases2022

Analysis of the HIV Vaccine Trials Network 702 Phase 2b-3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk.

Zoe Moodie, One Dintwe, Sheetal Sawant, Doug Grove, Yunda Huang, Holly Janes, Jack Heptinstall, Faatima Laher Omar, Kristen Cohen, Stephen C De Rosa and 38 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02968849 (A Pivotal Phase 2b/3 Multisite, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALVAC-HIV), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
–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.

NCT02968849 phase2 / phase3completednot on this map

A Pivotal Phase 2b/3 Multisite, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in Preventing HIV-1 Infection in Adults in South Africa

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2021Enrolled5,404ConditionsHIV InfectionsArmsALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed.

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  10. AS01Frontiers in immunology · 2026
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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

48 authors.

Zoe MoodieVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0001-8701-2001
One DintweVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Sheetal SawantCenter for Human Systems Immunology, Duke University, Durham, North Carolina, USA.
Doug GroveVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Yunda HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Holly JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0002-3237-984X
Jack HeptinstallCenter for Human Systems Immunology, Duke University, Durham, North Carolina, USA.
Faatima Laher OmarCape Town HVTN Immunology Laboratory, Hutchinson Centre Research Institute of South Africa, Cape Town, South Africa.
Kristen CohenVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Stephen C De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Lu ZhangCenter for Human Systems Immunology, Duke University, Durham, North Carolina, USA.
Nicole L YatesCenter for Human Systems Immunology, Duke University, Durham, North Carolina, USA.
Marcella Sarzotti-KelsoeDepartment of Surgery, Duke University, Durham, North Carolina, USA.
Kelly E SeatonCenter for Human Systems Immunology, Duke University, Durham, North Carolina, USA.
Fatima LaherPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Linda Gail BekkerDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Mookho MalahlehaSetshaba Research Centre, Soshanguve, South Africa.
Craig InnesThe Aurum Institute, Klerksdorp, South Africa.
Sheetal KassimDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Nivashnee NaickerCentre for the AIDS Programme of Research in South Africa, Durban, South Africa.
Vaneshree GovenderSouth African Medical Research Council, Durban, South Africa.
Modulakgotla SebeAurum Institute, Tembisa, South Africa.
Nishanta SinghSouth African Medical Research Council, Durban, South Africa.
Philip KotzeQhakaza Mbokodo Research Centre, Ladysmith, South Africa.
Erica LazarusPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Maphoshane NchabelengMecru Clinical Research Unit, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Amy M WardDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
William BrumskineAurum Institute, Johannesburg, South Africa.
Thozama DubulaNelson Mandela Academic Clinical Research Unit and Department of Internal Medicine and Pharmacology, Walter Sisulu University, Mthatha, South Africa.
April K RandhawaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Nicole GrunenbergVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
John HuralVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Jia Jin KeeVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.ORCID 0000-0002-1019-8343
Yutong JinDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Mary AllenNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Patricia D'SouzaNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
James TartagliaSanofi-Pasteur, Swiftwater, Pennsylvania, USA.
Carlos A DiazGranadosSanofi-Pasteur, Swiftwater, Pennsylvania, USA.
Marguerite KoutsoukosGSK, Wavre, Belgium.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Erica Andersen-NissenVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Glenda E GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Georgia D TomarasCenter for Human Systems Immunology, Duke University, Durham, North Carolina, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Nwora Lance Okeke · 2005 to 2026
$50.5M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitUM1AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI QUARRAISHA ABDOOL KARIM · 2012 to 2026
$36.4M
NIAID NIH HHS HHSN272201600012CNIAID NIH HHS P30 AI064518NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069469
6 · The paper itself

Abstract

backgroundThe 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 risk in RV144 were measured in HVTN 702 and evaluated as correlates of HIV-1 acquisition.

methodsAmong 1893 HVTN 702 female vaccinees, 60 HIV-1-seropositive cases and 60 matched seronegative noncases were sampled. HIV-specific CD4+ T-cell and binding antibody responses were measured 2 weeks after fourth and fifth immunizations. Cox proportional hazards models assessed prespecified responses as predictors of HIV-1 acquisition.

resultsThe HVTN 702 Env-specific CD4+ T-cell response rate was significantly higher than in RV144 (63% vs 40%, P = .03) with significantly lower IgG binding antibody response rate and magnitude to 1086.C V1V2 (67% vs 100%, P < .001; Pmag < .001). Although no significant univariate associations were observed between any T-cell or binding antibody response and HIV-1 acquisition, significant interactions were observed (multiplicity-adjusted P ≤.03). Among vaccinees with high IgG A244 V1V2 binding antibody responses, vaccine-matched CD4+ T-cell endpoints associated with decreased HIV-1 acquisition (estimated hazard ratios = 0.40-0.49 per 1-SD increase in CD4+ T-cell endpoint).

conclusionsHVTN 702 and RV144 had distinct immunogenicity profiles. However, both identified significant correlations (univariate or interaction) for IgG V1V2 and polyfunctional CD4+ T cells with HIV-1 acquisition. Clinical Trials Registration . NCT02968849.

Indexed as

AIDS VaccinesHIV-1HIV InfectionsHIV SeropositivityFemaleHIV AntibodiesHIV Envelope Protein gp120HumansImmunoglobulin GMaleSouth AfricaAIDS VaccinesHIV AntibodiesHIV Envelope Protein gp120Immunoglobulin Gbinding antibodiescorrelates of riskHIV-1 vaccineHVTN 702intracellular cytokine stainingRV144T-cell immunogenicityT-cell polyfunctionalityvaccine efficacy trialvaccine-induced immune response

Identifiers

PMID35758878
PMCPMC9890908

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Registered trials

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.