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

Sponsor

Wyeth-Lederle Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT00002231

Collaborator

(none)

Location

Study Details

Study Description

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 Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

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.