HIV Infections, HIV Seronegativity
Conditions
Keywords
Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALAPL 400-003
Sponsors
Wyeth-Lederle Vaccines
Study design
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Countries
United States
Outcome results
None listed