NCT03505060

Evaluating the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-Administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adults

A Phase 1b Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adult Participants

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (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 and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults.

Detailed description

This study will evaluate the safety and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults. Participants will be randomly assigned to two groups. Participants in Group 1 will receive 4 mg of DNA CON-S env at Months 0 and 1. They will receive 4 mg of DNA CON-S env and 150 mcg of IHV01 at Months 3 and 6. Participants in Group 2 will receive placebo at Months 0, 1, 3, and 6. Study visits will occur at Day 0 (study entry), Week 2, and Months 1, 1.5, 3, 3.5, 6, 6 + 1 week, 6.5, and 12. Visits may include physical examinations, medical history, injection of study product, blood and urine collection, pregnancy testing, HIV testing, risk reduction counseling, and questionnaires.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	DNA CON-S env	Administered by intramuscular injection in the deltoid.
BIOLOGICAL	IHV01	Administered by intramuscular injection in the deltoid.
BIOLOGICAL	Placebo	Sodium Chloride for Injection, USP 0.9%; administered by intramuscular injection in the deltoid.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-05-01
• Completion: 2019-11-11
• First posted: 2018-04-23
• Last updated: 2021-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study