RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Just in case you have not seen this, SciVacPer website: https://clinicaltrials.gov/show/NCT01437475 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: Tel-Aviv Sourasky Medical Center 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 Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record 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: MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis B 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 Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. 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: HIV Seropositivity HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases ............................................................................................................................................................................. ClinicalTrials.gov processed this record on May 06, 2015