NCT03934541

Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.

Detailed description

This study will evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults. Participants will be randomly assigned to four groups. Participants in Group 1 (Treatment 1) will receive 500 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 1 (Control 1) will receive placebo at Months 0, 2, and 6. Participants in Group 2 (Treatment 2) will receive 2000 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 2 (Control 2) will receive placebo at Months 0, 2, and 6. Study staff will review safety data from Group 1 before deciding whether to enroll Group 2. Participants will attend several study visits through Month 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 18 for follow-up health monitoring. As of May 2020, vaccinations were discontinued for all participants.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	MPER-656 Liposome Vaccine	Administered by intramuscular injection
BIOLOGICAL	Placebo for MPER-656 Liposome Vaccine	Administered by intramuscular injection

Timeline

• Start date: 2019-08-26
• Primary completion: 2021-02-05
• Completion: 2021-05-26
• First posted: 2019-05-02
• Last updated: 2025-09-25
• Results posted: 2022-05-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study