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

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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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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