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

Not Applicable

• Conditions: HIV
• Interventions: Biological: Sci-B-Vac

• Registration Number: NCT01437475
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-21
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06
• Study Start: 2011-11
• Primary Completion: 2013-03
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sci-B-Vac	Sci-B-Vac	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dan Turner; 🇮🇱 Tel Aviv, Israel