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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
Est. completion date
Est. primary completion date
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


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, 

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