A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

April 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004579 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection

Official Title ^ICMJE

A Phase I, Dose-Ranging Trial of the Pasteur Merieux Connaught (PMC) Oligomeric HIV-1 gp160MN/LAI-2 Vaccine Alone or Primed With Live Recombinant ALVAC-HIV (vCP205) in HIV Seronegative Adults

Brief Summary

The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.

Detailed Description

This study consists of 2 parts:

Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled, randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting.

Volunteers are followed for at least 1 year.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Double-Blind, Safety Study

Condition ^ICMJE

HIV Infections
HIV Seronegativity

Intervention ^ICMJE

Biological: gp160 MN/LAI-2
Biological: ALVAC-HIV MN120TMG (vCP205)

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

Volunteers may be eligible for this study if they:

Are HIV-negative.
Are in good health.
Are between ages 18 and 55.
Are available for at least 1 year.
Are a resident of the United States of America.
Agree to practice sexual abstinence or use birth control.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.)
Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection.
Have certain psychiatric, medical, or substance abuse problems.
Are allergic to eggs or other vaccines.
Are an employee at a participating site and have access to study information.
Are taking certain medications.
Have received blood transfusions within 3 months before entering this study.
Are pregnant or breast-feeding.

Gender

Both

Ages

18 Years to 55 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

NCT00004579

Responsible Party

Study ID Numbers ^ICMJE

RV124

Study Sponsor ^ICMJE

Walter Reed Army Institute of Research (WRAIR)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jerome H. Kim

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

June 2003

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