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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

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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.




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