HIV
Conditions
Keywords
HBV, HIV, Immunization, HBV Immunization rate among HIV positive individuals
Brief 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.
Interventions
BIOLOGICALSci-B-Vac
10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly
Sponsors
SciGen, Israel
Tel-Aviv Sourasky Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV immunization rate after 1, 2 and 3rd dose of Sci-B-Vac | 12 months | 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. |
Countries
Israel
Outcome results
None listed