NCT03382418

Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will 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. Participants will be randomly assigned to one of three groups. Participants in Group 1 will receive 300 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 2 will receive 100 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 3 will receive placebo on Day 0 and Months 2 and 6. Study visits will occur at Day 0 (study entry), Weeks 1 and 2, and Months 2, 2.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	gp145 C.6980 Vaccine	Administered by intramuscular injection in the deltoid.
BIOLOGICAL	Placebo	Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.
BIOLOGICAL	Aluminum Hydroxide Adjuvant	Administered by intramuscular injection in the deltoid.

Timeline

• Start date: 2017-12-27
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2017-12-22
• Last updated: 2021-10-08
• Results posted: 2021-07-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study