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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Wyeth-Lederle Vaccines
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002231

Purpose

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	Intervention	Phase
HIV Infections HIV Seronegativity	Biological: APL 400-003	Phase I

Study Type:	Interventional
Study Design:	Prevention, Open Label, Safety Study
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 NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002231

Locations

United States, Pennsylvania
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Wyeth-Lederle Vaccines

Investigators

Study Chair:

RR MacGregor

More Information

No publications provided

Study ID Numbers:	004, 04/400-003-04
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002231 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 25, 2009