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

Launched by WYETH-LEDERLE VACCINES · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.