NCT00249106

Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults

Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of Clade C DNA Vaccine ADVAX e/g + ADVAX p/N-t (ADVAX) Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), 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 vaccination and will be followed for 18 months after the first vaccination. 15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	ADVAX

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-11-07
• Last updated: 2013-02-11

Locations

2 sites across 1 country: United States