Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients
Recruitment status was Not yet recruiting
HBV vaccination is of paramount importance among HIV positive persons due to an increased risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive individuals.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Efficiency of the Novel Hepatitis B Vaccine Sci-B-Vac in HIV Positive Patients, a Prospective Cohort Study|
- HBV immunization rate after 1, 2 and 3rd dose of Sci-B-Vac [ Time Frame: 12 months ] [ Designated as safety issue: No ]HBV Surface antibodies will be obtained one month after each Sci-B-Vac dose for each vaccinee. Rate and rapidity of immunization will be measured.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
The study involves only one, open label arm. Rate of immunization will be compared to results obtained using the ENGERIX B vaccine among HIV positive persons in formerly published, historical cohorts.
10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly
A cohort of 100 HIV positive, HBV negative individuals who have not been vaccinated against HBV before will be prospectively given 3 doses of Sci-B-Vac at 0, 1 and 6 months. HBV antibodies will be checked one month after every dose given.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437475
|Dan Turner||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Dan Turner, MD 9725266656 firstname.lastname@example.org|
|Study Chair:||Dan Turner, MD||Tel-Aviv Sourasky Medical Center|
|Principal Investigator:||Danny Alon, MD||Tel-Aviv Sourasky Medical Center|