Evidence map›Paper›PMID 37679276›Full record

Trial reportVaccine2023

Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1-uninfected adult participants in the US.

Hong-Van Tieu, Shelly Karuna, Yunda Huang, Magdalena E Sobieszczyk, Hua Zheng, Georgia D Tomaras, David C Montefiori, Mingchao Shen, Stephen DeRosa, Kristen Cohen and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03382418 (A Phase 1 Double-Blind, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Oligomeric gp145 Clade C Env Protein), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 45% of its field
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.

NCT03382418 phase1completednot on this map

A Phase 1 Double-Blind, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Oligomeric gp145 Clade C Env Protein (gp145 C.6980) in Healthy, HIV-1-Uninfected Adult Participants in the US

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2019Enrolled45ConditionsHIV InfectionsArmsgp145 C.6980 Vaccine, Placebo, Aluminum Hydroxide Adjuvant
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

20 authors at 9 institutions in 1 country.

Hong-Van TieuLaboratory of Infectious Disease Prevention, Lindsley F. Kimball Research Institute, New York Blood Center, USA; Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, USA.
Shelly KarunaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Yunda HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA.
Magdalena E SobieszczykDivision of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, USA.
Hua ZhengVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Georgia D TomarasDepartment of Global Health, University of Washington, Seattle, WA, USA.
David C MontefioriDepartment of Global Health, University of Washington, Seattle, WA, USA.
Mingchao ShenVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Stephen DeRosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Kristen CohenVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Margaret Brewinski IsaacsDivision of Refugee Health, Administration for Children and Families, Department of Health and Human Services, USA.
Stephanie RegenoldDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Jack HeptinstallDepartment of Surgery, Duke University, Durham, NC, USA.
Kelly E SeatonDepartment of Surgery, Duke University, Durham, NC, USA.
Sheetal SawantDepartment of Surgery, Duke University, Durham, NC, USA.
Brianna FurchVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Michael PensieroDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Katharine J BarDepartment of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: bark@pennmedicine.upenn.edu.
HVTN 122 Study Team
Fred Hutch Cancer Center · USDuke University · USNational Institute of Allergy and Infectious Diseases · USUniversity of Washington · USAdministration for Children and Families · USColumbia University Irving Medical Center · USInfectious Disease Research Institute · USNew York Blood Center · USPenn Center for AIDS Research · US

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
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
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
NIAID NIH HHS U01 AI069470NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069534
6 · The paper itself

Abstract

backgroundAn approach to a preventive HIV vaccine is induction of effective broadly neutralizing antibodies (bnAbs) and effector binding antibodies (bAbs). Preclinical studies suggest that trimeric envelope (Env) proteins may elicit nAbs, which led to the development of the recombinant gp145 subtype C Env protein (gp145 C.6980) immunogen. HVTN 122 was a Phase 1 trial that evaluated the safety, tolerability, and immunogenicity of gp145 C.6980 in adults.

methodsHealthy, HIV-1 seronegative adults received three intramuscular injections of gp145 C.6980 with aluminum hydroxide (alum) at months 0, 2, and 6 at either 300 mcg (high dose, n = 25) or 100 mcg (low dose, n = 15), or placebo/saline (placebo, n = 5). Participants were followed for 12 months.

resultsForty-five participants were enrolled. High and low doses of the study protein were well-tolerated, with mild or moderate reactogenicity commonly reported. Only one adverse event (mild injection site pruritis) in one participant (low dose) was considered product-related; there were no dose-limiting toxicities. High and low dose recipients demonstrated robust bAb responses to vaccine-matched consensus gp140 Env and subtype-matched gp120 Env proteins two weeks post-last vaccination (response rates >90 %), while no responses were detected to a heterologous subtype-matched V1V2 antigen. No significant differences were seen between high and low dose groups. Participants in both experimental arms demonstrated nAb response rates of 76.5 % to a tier 1 virus (MW9635.26), but no responses to tier 2 isolates. Env-specific CD4 + T-cell responses were elicited in 36.4 % of vaccine recipients, without significant differences between groups; no participants demonstrated CD8 + T-cell responses.

conclusionsThree doses of novel subtype C gp145 Env protein with alum were safe and well-tolerated. Participants demonstrated bAb, Env-specific CD4 + T-cell, and tier 1 nAb responses, but the regimen failed to induce tier 2 or heterologous nAb responses. CLINICAL TRIALS REGISTRATION: NCT03382418.

Indexed as

AIDS VaccinesAntibodies, Neutralizingenv Gene Products, Human Immunodeficiency VirusHIV-1HIV AntibodiesHIV InfectionsAdjuvants, ImmunologicAdolescentAdultFemaleHealthy VolunteersHumansImmunogenicity, VaccineInjections, IntramuscularMaleMiddle AgedAdjuvants, ImmunologicAIDS VaccinesAntibodies, Neutralizingenv Gene Products, Human Immunodeficiency VirusHIV AntibodiesVaccines, SyntheticHIV-1HIV vaccineNIHPhase 1 clinical trialSubtype C gp145 Env proteinTrimeric envelope protein

Identifiers

PMID37679276
PMCPMC11446254
OpenAlexW4386531383

What OpenQuestion holds

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LicenceTDM
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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.