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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
SciGen, Israel, the vaccine manufacturer, will be providing 300 Sci-B-Vac doses
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01437475
First received: September 19, 2011
Last updated: October 5, 2011
Last verified: October 2011

September 19, 2011
October 5, 2011
November 2011
March 2013   (final data collection date for primary outcome measure)
HBV immunization rate after 1, 2 and 3rd dose of Sci-B-Vac [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01437475 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Biological: Sci-B-Vac
10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly
Experimental: 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.
Intervention: Biological: Sci-B-Vac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
November 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Israel
 
NCT01437475
TASMC-11-DA-0277-CITL
No
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
SciGen, Israel, the vaccine manufacturer, will be providing 300 Sci-B-Vac doses
Study Chair: Dan Turner, MD Tel-Aviv Sourasky Medical Center
Principal Investigator: Danny Alon, MD Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP