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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections HIV Seronegativity

Study Design

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Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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APL 400-003

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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RR MacGregor

Role: STUDY_CHAIR

Locations

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Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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04/400-003-04

Identifier Type: -

Identifier Source: secondary_id

004