NCT00252148

Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults

Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of a Modified Vaccinia Ankara (MVA) Vectored HIV-1 (ADMVA) Vaccine Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety of an immune response to an investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not infected with HIV

Detailed description

This is a dose escalation trial. Study site staff and volunteers will be blinded. Blinding will not apply to the assignment of dose levels (low, middle or high). Volunteers will be screened up to 42 days before enrolment and will be followed for 18 months after the first vaccination. 16 volunteers will be randomized in a 3:1 ratio of active vaccine to placebo. Safety and tolerability of the ADMVA vaccine/placebo will be evaluated at least 14 days after the 12th volunteer in the low dose group receives the second injection before proceeding to the middle dose group.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	ADMVA	experimental HIV vaccine, MVA vector expressing HIV clade C env, gag, pol, nef, and tat

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-11-11
• Last updated: 2013-02-11

Locations

2 sites across 1 country: United States