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

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

This study has been completed.

Study NCT00004579. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

Prevention, Double-Blind, Safety Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections
HIV Seronegativity

Intervention ^†

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

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

April 1998

Completion Date

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00004579

Organization ID

RV124

Secondary IDs ^††

Study Sponsor ^†

Walter Reed Army Institute of Research (WRAIR)

Collaborators ^††

Investigators ^†

Principal Investigator:

Jerome H. Kim

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

June 2003

First Received Date ^†

November 2, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.