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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002231
• Other study ID #: 004
• Secondary ID: 04/400-003-04
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• APL 400-003

Locations

Country	Name	City	State
United States	Univ of Pennsylvania Med Ctr	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth-Lederle Vaccines

Country where clinical trial is conducted

United States,