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HVTN 505

Status
Stopped Early
Phase
IIb
Principal Investigator(s)
Scott Hammer, Columbia University
Objective

To determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.



last updated March 27, 2021
Prevention Option(s)
HIV Vaccine
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28, and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168.
Mode of Delivery
Intramuscular
Products
Ad5
DNA plasmid
ARMs
Experimental
Description
Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168.
Mode of Delivery
Intramuscular
Products
DNA
ARMs
Placebo Comparator
Results
Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine
Official Code
NCT00865566
Related Publications
Immunogenicity of DNA vaccines in humans: it takes two to tango.
Use of adenovirus in vaccines for HIV.
An effective HIV vaccine: A combination of humoral and cellular immunity?
Trial Sponsors
National Institute of Allergy and Infectious Diseases (NIAID), HIV Vaccine Trials Network
June 2009
August 2017
Enrollment
2 504
18
Years
50
Years
Population
Men
MSM
Sites

3535 Market Street CRS

Philadelphia, Pennsylvania
United States of America

Alabama Vaccine CRS

Birmingham, Alabama
United States of America

Baylor Vaccine Research Center CRS

Houston, Texas
United States of America

Boston Medical Center

Boston
United States of America

Brigham and Women's Hospital CRS

Boston, Massachusetts
United States of America

Care-Id CRS

Annandale, Virginia
United States of America

Case CRS

Cleveland, Ohio
United States of America

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts
United States of America

Seattle Vaccine and Prevention CRS

Seattle, Washington
United States of America

HIV Prevention & Treatment CRS

New York, New York
United States of America

Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia
United States of America

New York University HIV/AIDS CRS

New York, New York
United States of America

Orlando Immunology Center HVTN CRS

Orlando, Florida
United States of America

San Francisco Vaccine and Prevention CRS

San Francisco, California
United States of America

The AIDS Research Alliance of America CRS

Los Angeles, California
United States of America

UCI Project WISH CRS

Chicago, Illinois
United States of America

University of Colorado Hospital CRS

Aurora, Colorado
United States of America

University of Rochester HVTN CRS

Rochester, New York
United States of America

University of Texas Southwestern CRS

Dallas, Texas
United States of America

Vanderbilt Vaccine CRS

Nashville, Tennessee
United States of America

VRC Clinical Trials Core CRS

Bethesda, Maryland
United States of America