NCT00272493View on ClinicalTrials.gov

Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

Not specified

Primary Completion Date

November 30, 2007

Study Completion Date

September 30, 2008

Conditions
HIV Infections
Interventions
BIOLOGICAL

Hepatitis B virus vaccine with GM-CSF adjuvant

Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.

BIOLOGICAL

Hepatitis B virus vaccine

Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.

Trial Locations (11)

27710

Univ. of Rochester ACTG CRS, Durham

43210

The Ohio State Univ. AIDS CRS, Columbus

60611

Rush Univ. Med. Ctr. ACTG CRS, Chicago

98104

University of Washington AIDS CRS, Seattle

60611-3015

Northwestern University CRS, Chicago

63108-2138

Washington U CRS, St Louis

10016-6481

NY Univ. HIV/AIDS CRS, New York

14642-0001

Univ. of Rochester ACTG CRS, Rochester

45267-0405

Univ. of Cincinnati CRS, Cincinnati

44106-5083

Case CRS, Cleveland

44109-1998

MetroHealth CRS, Cleveland

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00272493 - Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals | Biotech Hunter | Biotech Hunter