NCT01437475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

1.3 years

First QC Date

September 19, 2011

Last Update Submit

October 5, 2011

Conditions

HIV

Keywords

HBVHIVImmunizationHBV Immunization rate among HIV positive individuals

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Sci-B-Vac

EXPERIMENTAL

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

Interventions

Sci-B-VacBIOLOGICAL

10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly

Sci-B-Vac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women
  • HBV positivity
  • Previous HBV vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dan Turner

Tel Aviv, 64239, Israel

Location

Related 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.

    BACKGROUND

MeSH Terms

Interventions

Pre-S vaccine

Study Officials

  • Dan Turner, MD

    Tel-Aviv Sourasky Medical Center

    STUDY CHAIR

  • Danny Alon, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 21, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2013

Study Completion

November 1, 2013

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

IL(1)