Evidence map›Paper›PMID 36348617›Full record

Trial reportThe Journal of infectious diseases2023

Safety and Immunogenicity of Ad26-Vectored HIV Vaccine With Mosaic Immunogens and a Novel Mosaic Envelope Protein in HIV-Uninfected Adults: A Phase 1/2a Study.

Daniel J Stieh, Dan H Barouch, Christy Comeaux, Michal Sarnecki, Kathryn E Stephenson, Stephen R Walsh, Sheetal Sawant, Jack Heptinstall, Georgia D Tomaras, James G Kublin and 19 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02935686 (A Randomized, Parallel-group, Placebo-controlled, Double-blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

NCT02935686 phase1 / phase2completednot on this map

A Randomized, Parallel-group, Placebo-controlled, Double-blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens: Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Either Clade C gp140 Plus Adjuvant OR a Combination of Mosaic and Clade C gp140 Plus Adjuvant

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2017 to 2023Enrolled155ConditionsHealthyArmsAd26.Mos4.HIV, Clade C gp140 plus adjuvant, Clade C gp140/Mosaic gp140 plus adjuvant, Placebo, gp140 HIV Bivalent Vaccine
3 · Its place in the literature

Who cites it

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

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  16. The multiverse of CD46 and oncologic interactions.The Journal of clinical investigation · 2025
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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

29 authors.

Daniel J StiehJanssen Vaccines and Prevention Leiden, the Netherlands.
Dan H BarouchBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Christy ComeauxJanssen Vaccines and Prevention Leiden, the Netherlands.
Michal SarneckiJanssen Vaccines, Bern, Switzerland.
Kathryn E StephensonBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Stephen R WalshCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Sheetal SawantDepartment of Surgery, Center for Human Systems Immunology, and Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA.
Jack HeptinstallDepartment of Surgery, Center for Human Systems Immunology, and Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA.
Georgia D TomarasDepartment of Surgery, Center for Human Systems Immunology, and Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA.
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Kristen W 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.
Galit AlterRagon Institute of MGH, MIT, and Harvard, Cambridge, Massachusetts, USA.ORCID 0000-0002-7680-9215
Guido FerrariDepartment of Surgery, Center for Human Systems Immunology, and Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA.
David MontefioriDepartment of Surgery, Center for Human Systems Immunology, and Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA.
Philipp MannVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Steven NijsJanssen Research and Development, Beerse, Belgium.
Katleen CallewaertJanssen Research and Development, Beerse, Belgium.
Paul A GoepfertDivision of Infectious Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Srilatha EdupugantiDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Etienne KaritaRwanda Zambia HIV Research Group, Kigali, Rwanda.
Michael S SeamanBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Lindsey R BadenBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Maria G PauJanssen Vaccines and Prevention Leiden, the Netherlands.
Hanneke SchuitemakerJanssen Vaccines and Prevention Leiden, the Netherlands.
Frank TomakaJanssen Research and Development, Titusville, New Jersey, USA.
ASCENT/HVTN118/HPX2003 Study Team

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
Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ronald G Collman · 1999 to 2026
$78.6M
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
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
San Francisco Vaccine and Prevention UnitU01AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI BUCHBINDER, SUSAN · 2007 to 2011
$7.3M
NCATS NIH HHS UL1 TR001102NIAID NIH HHS P30 AI045008NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069496NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069534NIH HHS
6 · The paper itself

Abstract

backgroundDeveloping a cross-clade, globally effective HIV vaccine remains crucial for eliminating HIV.

methodsThis placebo-controlled, double-blind, phase 1/2a study enrolled healthy HIV-uninfected adults at low risk for HIV infection. They were randomized (1:4:1) to receive 4 doses of an adenovirus 26-based HIV-1 vaccine encoding 2 mosaic Gag and Pol, and 2 mosaic Env proteins plus adjuvanted clade C gp140 (referred to here as clade C regimen), bivalent protein regimen (clade C regimen plus mosaic gp140), or placebo. Primary end points were safety and antibody responses.

resultsIn total 152/155 participants (clade C, n = 26; bivalent protein, n = 103; placebo, n = 26) received ≥1 injection. The highest adverse event (AE) severity was grade 3 (local pain/tenderness, 12%, 2%, and 0% of the respective groups; solicited systemic AEs, 19%, 15%, 0%). HIV-1 mosaic gp140-binding antibody titers were 79 595 ELISA units (EU)/mL and 137 520 EU/mL in the clade C and bivalent protein groups (P < .001) after dose 4 and 16 862 EU/mL and 25 162 EU/mL 6 months later. Antibody response breadth against clade C gp140 and clade C/non-clade C gp120 was highest in the bivalent protein group.

conclusionsAdding mosaic gp140 to the clade C regimen increased and broadened the elicited immune response without compromising safety or clade C responses. Clinical Trials Registration. NCT02935686.

Indexed as

AIDS VaccinesHIV-1HIV InfectionsAdultGenetic VectorsHIV AntibodiesHumansImmunogenicity, VaccineAIDS VaccinesHIV AntibodiesAd26 HIV vaccinebroad immunogenicitycross-cladeheterologous regimenmosaic HIV antigentetravalent

Identifiers

PMID36348617
PMCPMC10202119

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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.