Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers

Wyeth

Status and phase: Completed; Phase 1

Conditions: HIV Infections; HIV Seronegativity

Treatments: Biological: APL 400-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002231

04/400-003-04

004

Details and patient eligibility

About

The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.

Full description

In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are 18 - 60 years old.
• Are HIV-negative and in good health.
• Are able to understand how infections such as HIV are spread.
• Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have hepatitis B or C.
• Have any condition that may prevent you from completing the study.
• Are allergic to bupivacaine, vaccines, or certain local anesthetics.
• Have taken certain medications or have received certain therapies that may affect your immune system.
• Have an immune system disorder or have received therapy for an immune system disorder.
• Have been exposed to HIV within 6 months prior to study entry.
• Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.
• Have received blood transfusions within 6 months prior to study entry.
• Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.
• Are pregnant or breast-feeding.