NCT01437475

Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients

Efficiency of the Novel Hepatitis B Vaccine Sci-B-Vac in HIV Positive Patients, a Prospective Cohort Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	Sci-B-Vac	10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-03-01
• Completion: 2013-11-01
• First posted: 2011-09-21
• Last updated: 2011-10-06

Locations

1 site across 1 country: Israel