Evidence map›Paper›PMID 39235529›Full record

Trial reportThe Journal of experimental medicine2024

Use of 3M-052-AF with Alum adjuvant in HIV trimer vaccine induces human autologous neutralizing antibodies.

William O Hahn, K Rachael Parks, Mingchao Shen, Gabriel Ozorowski, Holly Janes, Lamar Ballweber-Fleming, Amanda S Woodward Davis, Chris Duplessis, Mark Tomai, Antu K Dey and 27 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of experimental medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04177355 (A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults), which is not on this map. Cited by 26 papers.

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

NCT04177355 phase1completednot on this map

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2024Enrolled127ConditionsHIV InfectionsArmsBG505 SOSIP.664 gp140, Placebo, 3M-052-AF, CpG 1018, GLA-LSQ
3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

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  4. Priming of Multiple HIV Neutralizing B Cell Precursors in Humans.medRxiv : the preprint server for health sciences · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

37 authors.

William O Hahn *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-4613-0586
K Rachael Parks *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-5307-4455
Mingchao Shen *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0001-9714-8076
Gabriel OzorowskiDepartment of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, CA, USA.ORCID 0000-0002-9695-8138
Holly JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-3237-984X
Lamar Ballweber-FlemingVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-6180-5545
Amanda S Woodward DavisVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-6901-8271
Chris DuplessisDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.ORCID 0000-0003-3489-0913
Mark Tomai3M Healthcare , St. Paul, MD, USA.ORCID 0000-0002-6362-9151
Antu K DeyInternational AIDS Vaccine Initiative , New York, NY, USA.ORCID 0000-0001-7438-9379
Zachary K SagawaAccess to Advanced Health Institute , Seattle, WA, USA.ORCID 0009-0001-9846-211X
Stephen C De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-3871-4618
Aaron SeeseVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-5877-6229
Latha Kallur SiddaramaiahVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0009-0008-4998-3913
Leonidas StamatatosVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-1106-7097
Wen-Hsin LeeDepartment of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, CA, USA.ORCID 0000-0001-9445-6671
Leigh M SewallDepartment of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, CA, USA.ORCID 0000-0002-2020-2991
Dalton KarlinseyDepartment of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, CA, USA.ORCID 0009-0004-1786-905X
Hannah L TurnerDepartment of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, CA, USA.ORCID 0000-0002-4745-8057
Vanessa RubinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-2134-0576
Sarah FurthVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0001-5181-4651
Kellie MacPheeVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0009-0008-0993-4009
Michael DuffVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0009-0008-4279-0756
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-2179-2436
Michael C KeeferDepartment of Medicine, University of Rochester, Rochester, NY, USA.ORCID 0000-0001-9048-3621
Srilatha EdupugantiDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.ORCID 0000-0001-6566-9969
Ian FrankSchool of Medicine, University of Pennsylvania , Philadelphia, PA, USA.ORCID 0000-0002-7824-0106
Janine MaenzaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-3992-4193
Lindsey R BadenBrigham and Women's Hospital , Boston, MA, USA.ORCID 0009-0004-1752-1926
Ollivier HyrienVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-1909-2542
Rogier W SandersDepartment of Medical Microbiology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID 0000-0002-2324-8573
John P MooreDepartment of Microbiology and Immunology, Weill Medical College of Cornell University, New York, NY, USA.ORCID 0000-0002-9902-6096
Andrew B WardDepartment of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, CA, USA.ORCID 0000-0001-7153-3769
Georgia D TomarasCenter for Human Systems Immunology and Departments of Surgery and Integrative Immunobiology, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0001-8076-1931
David C MontefioriDepartment of Surgery, Duke University, Durham, NC, USA.ORCID 0000-0003-0856-6319
Nadine RouphaelHope Clinic, Emory University , Atlanta, GA, USA.ORCID 0000-0002-2512-7919
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-2276-7117

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
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ronald G Collman · 1999 to 2026
$78.6M
VirologyP30AI036214 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SUSAN JANET LITTLE · 1994 to 2026
$78.4M
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
Structural studies of native-like SOSIP trimersP01AI110657 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI MOORE, JOHN P · 2015 to 2024
$35.4M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
Gates Foundation OPP1107954NIAID NIH HHS P01 AI110657NIAID NIH HHS P30 AI036214NIAID NIH HHS P30 AI045008NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069534
6 · The paper itself

Abstract

Stabilized trimers preserving the native-like HIV envelope structure may be key components of a preventive HIV vaccine regimen to induce broadly neutralizing antibodies (bnAbs). We evaluated trimeric BG505 SOSIP.664 gp140 formulated with a novel TLR7/8 signaling adjuvant, 3M-052-AF/Alum, for safety, adjuvant dose-finding, and immunogenicity in a first-in-healthy adult (n = 17), randomized, and placebo-controlled trial (HVTN 137A). The vaccine regimen appeared safe. Robust, trimer-specific antibody, and B cell and CD4+ T cell responses emerged after vaccination. Five vaccinees developed serum autologous tier 2 nAbs (ID50 titer, 1:28-1:8647) after two to three doses targeting C3/V5 and/or V1/V2/V3 Env regions by electron microscopy and mutated pseudovirus-based neutralization analyses. Trimer-specific, B cell-derived monoclonal antibody activities confirmed these results and showed weak heterologous neutralization in the strongest responder. Our findings demonstrate the clinical utility of the 3M-052-AF/Alum adjuvant and support further improvements of trimer-based Env immunogens to focus responses on multiple broad nAb epitopes.

Indexed as

Adjuvants, ImmunologicAIDS VaccinesAlum CompoundsAntibodies, Neutralizingenv Gene Products, Human Immunodeficiency VirusAdjuvants, VaccineAdultB-LymphocytesCD4-Positive T-LymphocytesFemaleHIV-1HIV AntibodiesHIV InfectionsHumansMaleMiddle AgedAdjuvants, ImmunologicAdjuvants, VaccineAIDS VaccinesAlum Compoundsaluminum sulfateAntibodies, Neutralizingenv Gene Products, Human Immunodeficiency VirusHIV Antibodies

Identifiers

PMID39235529
PMCPMC11380150

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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.