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OpenTrials
Completed

NCT Number: NCT00002231

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APL 400-003

Biological

Sponsors and collaborators

Lead sponsor

Wyeth-Lederle Vaccines

Industry

Registry information

Official study 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

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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