Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|HIV||Biological: Sci-B-Vac||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficiency of the Novel Hepatitis B Vaccine Sci-B-Vac in HIV Positive Patients, a Prospective Cohort Study|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||November 2013|
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.
10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437475
|Dan Turner||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Dan Turner, MD 9725266656 email@example.com|
|Study Chair:||Dan Turner, MD||Tel-Aviv Sourasky Medical Center|
|Principal Investigator:||Danny Alon, MD||Tel-Aviv Sourasky Medical Center|