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

HIV Clinical Trial

Official title:

Efficiency of the Novel Hepatitis B Vaccine Sci-B-Vac in HIV Positive Patients, a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01437475
• Other study ID #: TASMC-11-DA-0277-CITL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 19, 2011
• Last updated: October 5, 2011
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Biological:
• Sci-B-Vac
10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly

Locations

Country	Name	City	State
Israel	Dan Turner	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	SciGen, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV immunization rate after 1, 2 and 3rd dose of Sci-B-Vac	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.	12 months	No