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

This study is not yet open for participant recruitment.
Verified October 2011 by Tel-Aviv Sourasky Medical Center
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
History of Changes
  Purpose

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.


Condition Intervention
HIV
 Biological: Sci-B-Vac

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficiency of the Novel Hepatitis B Vaccine Sci-B-Vac in HIV Positive Patients, a Prospective Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Biological: Sci-B-Vac
10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437475

Locations
Israel
Dan Turner Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Dan Turner, MD     9725266656     dan.turner@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
SciGen, Israel, the vaccine manufacturer, will be providing 300 Sci-B-Vac doses
Investigators
Study Chair: Dan Turner, MD Tel-Aviv Sourasky Medical Center
Principal Investigator: Danny Alon, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01437475     History of Changes
Other Study ID Numbers: TASMC-11-DA-0277-CITL
Study First Received: September 19, 2011
Last Updated: October 5, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
HBV
HIV
Immunization
HBV Immunization rate among HIV positive individuals

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
HIV Seropositivity
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
HIV Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on February 28, 2013