Evidence map›Paper›PMID 37795976›Full record

Trial reportThe Journal of infectious diseases2024

Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.

Zvavahera Mike Chirenje, Fatima Laher, One Dintwe, Monde Muyoyeta, Allan C deCamp, Zonglin He, Nicole Grunenberg, Faatima Laher Omar, Kelly E Seaton, Laura Polakowski and 22 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03122223 (A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of ALVAC-HIV), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03122223 phase1 / phase2completednot on this map

A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted Clade C Env Protein, in Healthy, HIV-uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2020Enrolled160ConditionsHIV InfectionsArmsALVAC-HIV (vCP2438), Bivalent subtype C gp120/MF59, Bivalent subtype C gp120/AS01(B), Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. AS01Frontiers in immunology · 2026
    Article
  3. Article
  4. Article
  5. Review
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

32 authors.

Zvavahera Mike ChirenjeDepartment of Obstetrics and Gynecology, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0003-3538-5150
Fatima LaherPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
One DintweCape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, South Africa.
Monde MuyoyetaCentre for Infectious Diseases Research in Zambia, Livingstone, Zambia.
Allan C deCampVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Zonglin HeVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Nicole GrunenbergVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Faatima Laher OmarCape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, South Africa.
Kelly E SeatonCenter for Human Systems Immunology, Duke University School of Medicine, Durham, North Carolina, USA.
Laura PolakowskiVaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Amanda S Woodward DavisVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Lucas MagangaNational Institute for Medical Research-Mbeya Medical Research Centre, Mbeya, Tanzania.
Lindsey R BadenDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Kenneth MayerBeth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts, USA.
Spyros KalamsDivision of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Michael KeeferDepartment of Medicine, University of Rochester, Rochester, NewYork, USA.
Srilatha EdupugantiDepartment of Medicine, Emory University, Atlanta, Georgia, USA.
Benigno RodriguezDivision of Infectious Diseases and HIV Medicine, Department of Medicine, Case Western Reserve University/University Hospitals, Cleveland Medical Center, Cleveland, Ohio, USA.
Ian FrankSchool of Medicine, University of Pennsylvania, Philadelphia, USA.
Hyman ScottSanFrancisco Department of Public Health, San Francisco, California, USA.
Lynda Stranix-ChibandaFaculty of Medicine and Health Science, University of Zimbabwe Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
Sanjay GurunathanSanofi Pasteur, Swiftwater, Pennsylvania, USA.
Marguerite KoutsoukosGSK, Wavre, Belgium.
Olivier Van Der MeerenGSK, Rixensart, Belgium.
Carlos A DiazGranadosSanofi Pasteur, Swiftwater, Pennsylvania, USA.
Carmen PaezVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Erica Andersen-NissenCape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, South Africa.
James KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0003-1279-3741
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Guido FerrariDepartment of Surgery, Duke University Medical Center, Durham, North Carolina, USA.
Georgia TomarasCenter for Human Systems Immunology, Duke University School of Medicine, Durham, North Carolina, USA.
M Juliana McElrathCape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, 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
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
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
University of Rochester HIV/AIDS Clinical Trials Unit Administrative SupplementUM1AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI Paul R Bohjanen, MICHAEL C KEEFER · 2012 to 2026
$25.7M
Units for HIV/AIDS Clinical Trials NetworksU01AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI KEEFER, MICHAEL C · 2007 to 2011
$12.0M
Bill and Melinda Gates Foundation OPP1017604NIAID NIH HHS HHSN272201300033CNIAID NIH HHS HHSN272201600012CNIAID NIH HHS U01 AI069511NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069511NIH HHS UM1 AI068614University of Rochester UM1
6 · The paper itself

Abstract

backgroundHVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults.

methodsParticipants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses.

resultsWe enrolled 160 participants, 55% women, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups.

conclusionsThe 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration . NCT03122223.

Indexed as

Adjuvants, ImmunologicAIDS VaccinesHIV AntibodiesHIV Envelope Protein gp120HIV InfectionsOff-Label UseVaccines, CombinedAdolescentAdultDouble-Blind MethodFemaleHIV-1HumansLipid AMalePolysorbatesAdjuvants, ImmunologicAIDS VaccinesALVAC vaccineAS01B adjuvantHIV AntibodiesHIV Envelope Protein gp120Lipid AMF59 oil emulsionPolysorbatesSaponinsSqualeneVaccines, CombinedViral VaccinesadjuvantdoseHIVvaccine

Identifiers

PMID37795976
PMCPMC11326849

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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.