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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: HIV

Treatments: Biological: Sci-B-Vac

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01437475

TASMC-11-DA-0277-CITL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Sci-B-Vac

Experimental group

Description:

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.

Treatment:

Biological: Sci-B-Vac