Evidence map›Paper›PMID 39302924›Full record

ArticlePLOS global public health2024

Safety and immunogenicity after a 30-month boost of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120/MF59 vaccine boost (HVTN 100): A phase 1-2 randomized double-blind placebo-controlled trial.

Vimla Naicker, Fatima Laher, Linda-Gail Bekker, Kelly E Seaton, Mary Allen, Stephen De Rosa, Nicole L Yates, Nonhlanhla N Mkhize, Kevin Saunders, Jack Heptinstall and 22 more

Registry-linked trialAbstract read
In one paragraph

Article in PLOS global public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02404311 (A Phase 1-2 Randomized, Double-blind, Placebo-controlled Clinical Trial of Clade C ALVAC-HIV), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02404311 phase1 / phase2completednot on this map

A Phase 1-2 Randomized, Double-blind, Placebo-controlled Clinical Trial of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59® in HIV-uninfected Adults at Low Risk of HIV Infection

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2015 to 2018Enrolled252ConditionsHIV InfectionArmsALVAC-HIV, Bivalent Subtype C gp120/MF59®, ALVAC-HIV (vCP2438) Placebo, Bivalent gp120/MF59® Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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.

Vimla NaickerSouth African Medical Research Council, Durban, South Africa.
Fatima LaherFaculty of Health Sciences, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0001-5231-9951
Linda-Gail BekkerDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Kelly E SeatonDepartments of Surgery and Integrative Immunobiology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0002-2009-3270
Mary AllenVaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Stephen De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Nicole L YatesDepartments of Surgery and Integrative Immunobiology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.
Nonhlanhla N MkhizeNational Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
Kevin SaundersDepartments of Surgery and Integrative Immunobiology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.
Jack HeptinstallDepartments of Surgery and Integrative Immunobiology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.
Mookho MalahlehaSynergy Biomed Research Institute, East London, South Africa.ORCID https://orcid.org/0000-0003-1879-8471
Kathryn MngadiCentre for the AIDS Programme of Research in South Africa, Durban, South Africa.ORCID https://orcid.org/0000-0002-7847-3671
Brodie DanielsSouth African Medical Research Council, Durban, South Africa.
Craig InnesAurum Institute, Klerksdorp Research Centre, Klerksdorp, South Africa.
Chenchen YuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Tandile ModiseNational Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
Valerie BekkerNational Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
Nicole GrunenbergVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Briana FurchVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Maurine D MinerVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.ORCID https://orcid.org/0000-0002-4637-1283
Sanjay PhogatSanofi Pasteur, Swiftwater, Pennsylvania, United States of America.
Carlos A DiazgranadosSanofi Pasteur, Swiftwater, Pennsylvania, United States of America.
Sanjay GurunathanSanofi Pasteur, Swiftwater, Pennsylvania, United States of America.
Marguerite KoutsoukosGSK, Wavre, Belgium.ORCID https://orcid.org/0000-0002-4174-8424
Olivier Van Der MeerenPreviously GSK, Rixensart, Belgium.ORCID https://orcid.org/0000-0003-0291-743X
Alison C RoxbyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Guido FerrariDepartment of Surgery, Center for Human System Immunology, Duke University School of Medicine, Durham, North Carolina, United States of America.
Lynn MorrisNational Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
David MontefioriDepartments of Surgery and Integrative Immunobiology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0003-0856-6319
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Georgia D TomarasDepartments of Surgery and Integrative Immunobiology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.
Zoe MoodieVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.ORCID https://orcid.org/0000-0001-8701-2001

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
Aurum Clinical Trials UnitUM1AI154463 · NIAID · AURUM INSTITUTE NPC · PI Gavin John Churchyard · 2021 to 2026
$8.1M
NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI154463
6 · The paper itself

Abstract

Induction of broad, durable immune responses is a challenge in HIV vaccine development. HVTN 100 Part A administered subtype C-containing ALVAC-HIV at months 0 and 1, and ALVAC-HIV with bivalent subtype C gp120/MF59 at months 3, 6 and 12. As IgG binding antibody and T-cell responses were similar or greater at month 12.5 vs. month 6.5, but waned by month 18, we investigated vaccine-elicited immune responses after a month 30 boost in this study, HVTN 100 Part B. From 13 September 2017 to 7 August 2018, a subgroup of vaccinees was randomized to receive intramuscular injections of ALVAC+gp120/MF59 (n = 32) or gp120/MF59 alone (n = 31) and a subgroup of placebo recipients was administered placebo (n = 7) at month 30. Primary outcomes were safety, IgG binding antibodies (bAbs) to vaccine-specific and V1V2 Env proteins and vaccine-specific CD4+ T cells at month 30.5. Secondary outcomes included neutralizing and antibody dependent cellular cytotoxicity functions and durability at months 30 and 36. Both vaccine groups had an acceptable safety profile. There were no statistically significant differences in the occurrence or level of IgG bAbs between the vaccine boost groups for any vaccine-specific or V1V2 antigens. IgG responses were higher to vaccine-matched gp120 than to V1V2. The booster vaccination restored the magnitude-breadth IgG bAb response to V1V2 antigens at month 30.5. However, it rapidly waned by month 36. CD4+ T-cell response rates to the 3 vaccine-matched Env antigens for the combined vaccine groups ranged from 37% at month 30, boosted to as high as 91% at month 30.5, and waned by month 36 to as low as 44%, with no significant differences between the vaccine boost groups. Because these responses waned after 6 months, additional strategies may be needed to maintain the durability of prime-boost vaccine regimens and to generate these or other immune responses that confer protection. Trial registration: South African National Clinical Trials Register (SANCTR number: DOH-27-0215-4796) and ClinicalTrials.gov (NCT02404311).

Identifiers

PMID39302924
PMCPMC11414935

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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.