CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
gp145 C.6980 Vaccine +2 morebiological
Likely dose
gp145 C.6980 vaccine administered by intramuscular injection in the deltoid (specific dose not stated)AI-extracted
Key inclusion· 6
  • ✓Age 18 to 50 years
  • ✓HIV-1 and HIV-2 negative by FDA-approved EIA
  • ✓Assessed as at 'low risk' for HIV infection and committed to maintaining low-risk behavior
  • ✓Good general health demonstrated by medical history, physical exam, and screening labs
Key exclusion· 15
  • ✕Prior HIV vaccine in an HIV vaccine trial
  • ✕Non-HIV experimental vaccine within the last 5 years
  • ✕Live attenuated vaccines (except influenza) within 30 days before or 14 days after first vaccination
  • ✕Immunosuppressive medications within 168 days before first vaccination (with specific exceptions for nasal/inhaled/topical corticosteroids and limited prednisone course)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382418
NCT03382418Phase 1Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 22, 2017·Updated Oct 8, 2021

In Brief

A Phase 1 clinical trial evaluating gp145 C.6980 Vaccine, Placebo, and 1 other intervention for HIV Infections. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 22, 2017
Enrollment StartDec 27, 2017
Primary CompletionSep 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.5 years ago

Interventions

gp145 C.6980 Vaccinebiological

Administered by intramuscular injection in the deltoid.

Placebobiological

Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.

Aluminum Hydroxide Adjuvantbiological

Administered by intramuscular injection in the deltoid.