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



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

For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): Walter Reed Army Institute of Research (WRAIR) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JeromeKim,  Principal Investigator, 

Walter Reed Army Institute of Research
Rockville,  Maryland, 
United States
 


Additional Information:
Study ID Numbers:  RV124; 
Study Start Date: April 1998
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004579

Other Hiv Infections Studies:
1. HIV Prevention Counseling for Men Who Have Sex with Men

2. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding

3. Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

4. A Study of the Effectiveness of an HIV Vaccine (ALVAC vCP205) to Boost Immune Functions in HIV-Negative Volunteers Who Have Already Received an HIV Vaccine

5. Botanical/Drug Interactions in HIV: Glucuronidation

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