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A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults

NCT03699241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-12-14

No results posted yet for this study

Summary

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

BG505 SOSIP.664 gp140, adjuvanted

Dosage of 30ug, Intramuscular administration

BIOLOGICAL

BG505 SOSIP.664 gp140, adjuvanted

Dosage of 100ug, Intramuscular administration

BIOLOGICAL

BG505 SOSIP.664 gp140, adjuvanted

Dosage of 300ug, Intramuscular administration

BIOLOGICAL

Placebo

Tris-NaCl Diluent

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Fred Hutchinson Cancer Research Center - Seattle HIV Vaccine Trials Unit

    collaborator UNKNOWN

  • Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)

    collaborator UNKNOWN

  • Massachusetts General Hospital

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Julie McElrath, MD, PhD · Seattle HIV Vaccine Trials Unit

  • Omu Anzala, MBChB, PhD · Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)

  • Boris Juelg, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2023-03-21
Completion
2023-07-11
FDA Drug
Yes

Countries

  • United States
  • Kenya

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 NCT03699241 on ClinicalTrials.gov