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A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults

NCT04224701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-05

No results posted yet for this study

Summary

This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted

30 µg

BIOLOGICAL

BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted

300 µg

BIOLOGICAL

Placebo

Tris NaCl Diluent

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Rockefeller University

    collaborator OTHER

  • George Washington University

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Marina Caskey, MD · Rockefeller University

  • Godelieve de Bree, MD, PhD · Amsterdam UMC, location VUmc

  • David Joseph Diemert, MD · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
51 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-07-05
Completion
2023-08-02
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224701 on ClinicalTrials.gov