Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults

HIV Infections Clinical Trial

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of VSV-Indiana HIV Gag Vaccine Given Intramuscularly in Healthy, HIV-1-Uninfected Adult Participants

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.

Clinical Trial Description

Many HIV vaccines that are in development use a virus vector to deliver the vaccine into the body's cells in order to elicit an immune response. Vesicular stomatitis virus (VSV) is a vector that has been studied in animals. As an HIV vaccine vector, it has been shown to prevent disease progression in monkeys infected with simian/human immunodeficiency virus (SHIV). This study will evaluate the safety and immune response to the VSV-Indiana (one type of VSV vector) HIV gag vaccine in healthy, HIV-uninfected adults. In addition, study researchers will determine the maximum dose of the vaccine that can be safely tolerated.

This study will enroll healthy, HIV-uninfected adults. Five groups of participants will be enrolled, with each subsequent group receiving a slightly higher dose of the vaccine. Within each group, participants will be randomly assigned to receive the study vaccine or a placebo vaccine. Study researchers will examine safety data and how participants react to the study vaccine before enrolling the next group of participants. At baseline and Week 8, participants will receive two injections of the study vaccine or placebo vaccine-one in each upper arm at each time point. At the baseline study visit, all participants will undergo a physical examination; mouth examination; a medical and medication history review; and saliva, blood, and urine collection. Female participants will also take a pregnancy test. Participants will complete questionnaires to assess mental status and receive counseling on HIV risk reduction and pregnancy prevention. After receiving the vaccine, participants will remain in the clinic for at least 30 minutes for observation and monitoring of side effects. For 7 days after the vaccination, participants will record any side effects in a symptom log.

Participants will attend study visits 3 days and 1 and 2 weeks after the baseline study visit, at Week 8 for the second vaccination, 3 days and 1 and 2 weeks after the Week 8 visit, and at Months 5 and 8. Follow-up study visits will include select baseline study procedures. Participants will be contacted annually for 3 years for follow-up health monitoring. ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT01438606
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: October 2011