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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437475
Recruitment Status : Unknown
Verified October 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 21, 2011
Last Update Posted : October 6, 2011
SciGen, Israel
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

September 19, 2011
September 21, 2011
October 6, 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 ]
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 Archive Site
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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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
1. R. van den Berg, I. van Hoogstraten and M. van Agtmael. Non-Responsiveness to Hepatitis B Vaccination in HIV Seropositive Patients; Possible causes and solutions. AIDS Rev. 2009;11:157-65. 2. O. Launay, D. van der Vilet, A. Rosenberg et al. Safety and Immunogenicity of 4 Intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1. JAMA, 2001; Vol 35. No.14:1432-1440. 3. Petit NN, DePestel DD, Malani PN et al. Factors associated with seroconversion after standard dose hepatitis B vaccination and high dose revaccination among HIV-infected patients. HIV Clin Trials. 2010 Nov-Dec;11(6):332-9. 4. MY Shapira, E. Zeira, R. Rapid seroprotection against hepatitis B following the first dose of a Pre-S1/Pre-S2/S vaccine. Journal of Hepatology 34 (2001); 123-127. 5. SM Fiedler, U. Dahmen, H. Grosse-Wilde et al. Cellular and humoral immune response to a third generation hepatitis B vaccine. Journal of viral hepatitis. 2007, 14: 592-598. 6. Paitoonpong L., Suankratay C. Immunological response to hepatitis B vaccination in patients with Aids and virological response to HAART. Scan J Infect Dis. 2008;40(1):54-8. 7. Laurence J. Hepatitis A and B immunizations of individuals infected with HIV. Am J Med. 2005;118 (Suppl. 10A: 75-93s). 8. Pasnicha N, Datta U, Chawla Y et al. Immune responses in patients with HIV infection after vaccination with recombinant hepatitis B virus vaccine. BMC Infec Dis 2008;8:85.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
SciGen, Israel
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