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

June 23, 2005 updated by: Wyeth-Lederle Vaccines

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth-Lederle Vaccines

Investigators

  • Study Chair: RR MacGregor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004
  • 04/400-003-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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