Evidence map›Paper›PMID 41959788›Full record

ArticlemedRxiv : the preprint server for health sciences2026

Safety and immunogenicity of an HIV envelope trimer immunogen that elicits CD4 binding site neutralizing antibody precursors (HVTN 300).

Stephen R Walsh, William O Hahn, Wilton B Williams, Ollivier Hyrien, Pei-Chun Yu, K Rachael Parks, Robert J Edwards, Rob Parks, Maggie Barr, Laura L Polakowski and 19 more

Registry-linked trialAbstract readPreprint
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04915768 (A First-in-human Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.), which is not on this map. Not yet cited in PubMed.

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

NCT04915768 phase1completednot on this map

A First-in-human Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2023 to 2025Enrolled51ConditionsHIV InfectionsArmsCH505 TF chTrimer, 3M-05-AF, Aluminum hydroxide suspension
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Stephen R WalshDivision of Infectious Diseases, Brigham & Women's Hospital, Boston, MA, United States.ORCID 0000-0002-0817-9370
William O HahnVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Wilton B WilliamsDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Ollivier HyrienVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Pei-Chun YuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
K Rachael ParksVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Robert J EdwardsDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Rob ParksDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Maggie BarrDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Laura L PolakowskiNational Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, United States.
India TindaleVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Megan JonesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Claudio YurdadonVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Randy BurnhamVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Chen-Hao YehDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Jack HeptinstallDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Kelly E SeatonDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Jessica G AndriesenVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Zachary SagawaAccess to Advanced Health Institute, Seattle, WA, United States.
Maurine D MinerVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Steve De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Georgia D TomarasDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
David C MontefioriDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Barton F HaynesDuke Human Vaccine Institute, Duke University, Durham, NC, United States.
Kenneth H MayerHarvard Medical School, Boston, MA, United States.
Lindsey R BadenDivision of Infectious Diseases, Brigham & Women's Hospital, Boston, MA, United States.
NIAID HVTN 300 Study Group

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 biology scientific research support componentUM1AI100645 · NIAID · DUKE UNIVERSITY · PI KELSOE, GARNETT H · 2012 to 2018
$204.7M
Nonhuman primate studies for development of a prototype HIV vaccine that induces broadly neutralizing antibodiesUM1AI144371 · NIAID · DUKE UNIVERSITY · PI HAYNES, BARTON F. · 2019 to 2025
$190.4M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
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
NCRR NIH HHS UL1 RR025758NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI100645NIAID NIH HHS UM1 AI144371
6 · The paper itself

Abstract

Background: Induction of HIV envelope (Env)-specific broadly neutralizing antibodies (bnAbs) is considered a key objective for HIV-1 vaccine development. One approach is to vaccinate with HIV Env immunogens that initially target the naïve B cell receptors of a bnAb type and boost with a series of HIV Env variants. We chose a priming immunogen, the CH505 transmitted/founder Env with high affinity for the naïve B cell receptor of the prototype CD4 binding site (bs) bnAb lineage, CH103, as a candidate priming immunogen to induce the initial critical step in CD4bs bnAb development. Methods: HVTN 300 is a first-in-human, open-label Phase 1 study evaluating the safety and immunogenicity of a CH505 TF chimeric (ch) Trimer adjuvanted with 3M-052-AF (a TLR7/8 agonist) + Alum. The immunogen is a recombinant, stabilized chimeric Env trimer protein with the N-terminal sequence of CH505 TF gp120 Env transplanted into the BG505 SOSIP sequence. Participants received the adjuvanted protein administered in both deltoid muscles at months 0, 2, 4, 8, and 12. Results: Adults (n=18) aged 18 to 55 were screened at a single site in Boston, USA, and 13 were enrolled. Local and systemic reactogenicity was typically mild to moderate. One participant had severe pain/tenderness, and five participants reported transient severe systemic symptoms at least once. Five participants chose to stop further vaccination due to reactogenicity. No vaccine-related SAEs occurred. Vaccine-specific B-cell response rates reached 100% two weeks post third and fifth vaccinations. Antibody blocking experiments with monoclonal antibodies demonstrated that most participants had antibodies directed to the CD4bs. Four out of 11 participants had serum neutralization signatures for CD4bs bnAb precursors. Conclusions: No safety concerns were identified. The adjuvanted CH505 TF chTrimer elicited serum antibodies capable of CD4bs-mediated neutralization against strains designed to detect early precursors of the CD4bs B-cell lineages. Trial Registration: NCT04915768.

Identifiers

PMID41959788
PMCPMC13060434

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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.