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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Open Label, Safety Study

Condition ^ICMJE

HIV Infections
HIV Seronegativity

Intervention ^ICMJE

Biological: APL 400-003

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002231

Responsible Party

Study ID Numbers ^ICMJE

004, 04/400-003-04

Study Sponsor ^ICMJE

Wyeth-Lederle Vaccines

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

RR MacGregor

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

May 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP