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NCT03547245

A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted

Completed Phase 1 Last updated 12 May 2022
What this trial tests

Phase 1 trial testing eOD-GT8 60mer + AS01B/ DPBS sucrose/IM in HIV/AIDS in 46 participants. Completed in 13 August 2021.

Timeline
15 June 2018
Primary endpoint
17 January 2020
13 August 2021

Quick facts

Lead sponsorInternational AIDS Vaccine Initiative
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposeprevention
Enrollment46
Start date15 June 2018
Primary completion17 January 2020
Estimated completion13 August 2021
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

International AIDS Vaccine Initiative — full company profile →

Who can join

Adults 18 to 50, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Elicitation of Potent Neutralizing Antibody Responses by Designed Protein Nanoparticle Vaccines for SARS-CoV-2.
    Walls AC, Fiala B, Schäfer A, Wrenn S, et al · · 2020 · cited 519× · PMID 33160446 · DOI 10.1016/j.cell.2020.10.043
  2. Multifaceted Effects of Antigen Valency on B Cell Response Composition and Differentiation In Vivo.
    Kato Y, Abbott RK, Freeman BL, Haupt S, et al · · 2020 · cited 244× · PMID 32857950 · DOI 10.1016/j.immuni.2020.08.001
  3. Vaccination induces HIV broadly neutralizing antibody precursors in humans.
    Leggat DJ, Cohen KW, Willis JR, Fulp WJ, et al · · 2022 · cited 240× · PMID 36454825 · DOI 10.1126/science.add6502
  4. Antibodies to combat viral infections: development strategies and progress.
    Pantaleo G, Correia B, Fenwick C, Joo VS, et al · · 2022 · cited 210× · PMID 35725925 · DOI 10.1038/s41573-022-00495-3
  5. Controlling timing and location in vaccines.
    Irvine DJ, Aung A, Silva M. · · 2020 · cited 198× · PMID 32598970 · DOI 10.1016/j.addr.2020.06.019
  6. Antibody Lineages with Vaccine-Induced Antigen-Binding Hotspots Develop Broad HIV Neutralization.
    Kong R, Duan H, Sheng Z, Xu K, et al · · 2019 · cited 145× · PMID 31348886 · DOI 10.1016/j.cell.2019.06.030
  7. A platform incorporating trimeric antigens into self-assembling nanoparticles reveals SARS-CoV-2-spike nanoparticles to elicit substantially higher neutralizing responses than spike alone.
    Zhang B, Chao CW, Tsybovsky Y, Abiona OM, et al · · 2020 · cited 108× · PMID 33097791 · DOI 10.1038/s41598-020-74949-2
  8. Targeted modulation of immune cells and tissues using engineered biomaterials.
    Yousefpour P, Ni K, Irvine DJ. · · 2023 · cited 105× · PMID 37772035 · DOI 10.1038/s44222-022-00016-2

Verify or expand the search:

Other recruiting trials for HIV/AIDS

Currently open trials in the same condition.

Other International AIDS Vaccine Initiative trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03547245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing