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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002231
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Seronegativity Biological: APL 400-003 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002231

United States, Pennsylvania
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Wyeth-Lederle Vaccines
Study Chair: RR MacGregor Identifier: NCT00002231     History of Changes
Other Study ID Numbers: 004
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Injections, Intramuscular
HIV Antibodies
Immunity, Cellular
AIDS Vaccines
HIV Seronegativity
Dose-Response Relationship, Immunologic
Vaccines, DNA

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs