Trial | NCT01437475  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    HIV

  • Study Participants

    100
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.
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.
Study Started
Nov 30
2011
Primary Completion
Mar 31
2013
Anticipated
Study Completion
Nov 30
2013
Anticipated
Last Update
Oct 06
2011
Estimate

Biological Sci-B-Vac

10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly

Sci-B-Vac Experimental

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.

Criteria 

Inclusion Criteria:

HBV negative
HIV positive individuals
Above the age of 18
Treated at the TASMC Aids clinic, who have signed and informed consent and have never been vaccinated against HBV before

Exclusion Criteria:

Pregnant women
HBV positivity
Previous HBV vaccination
No Results Posted