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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

APL 400-003

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Univ of Pennsylvania Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002231

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Wyeth-Lederle Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00002231

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2000

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Wyeth-Lederle Vaccines

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, HIV Seronegativity

Keywords

Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

APL 400-003

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RR MacGregor

Official's Role

Study Chair

Facility Information:

Facility Name

Univ of Pennsylvania Med Ctr

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

HIV Infections, HIV Seronegativity

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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