HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

PHASE2CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

February 29, 2008

Study Completion Date

January 31, 2010

Conditions
HIV Infections
Interventions
BIOLOGICAL

VRC-HIVDNA016-00-VP

4 mg administered in deltoid

BIOLOGICAL

VRC-HIVADV014-00-VP

1 x 10\^10 PU administered in deltoid

BIOLOGICAL

VRC-HIVDNA016-00-VP placebo

1 mL administered at study entry and Months 1 and 2

BIOLOGICAL

VRC-HIVADV014-00-VP placebo

1 mL administered at Month 6

Trial Locations (12)

21201

Project Brave HIV Vaccine CRS, Baltimore

37232

Vanderbilt Vaccine CRS, Nashville

35294-2041

Alabama Vaccine CRS, Birmingham

02115

Brigham and Women's Hosp. CRS, Boston

Miriam Hospital's HVTU, Providence

Unknown

Projeto Praca Onze/Hesfa Crs, Rio de Janeiro

Sao Paulo HVTU - CRT DST/AIDS CRS, São Paulo

Les Centres GHESKIO CRS, Port-au-Prince

Epidemiology Research & Training Unit Jamaica MOH CRS, Kingston

Soweto HVTN CRS, Johannesburg

Emavundleni Desmond Tutu HIV Centre CRS, Cape Town

CAPRISA Aurum CRS, Klerksdorp

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00125970 - HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants | Biotech Hunter | Biotech Hunter