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IRCT201109113307N5 IRCT 2011-09-19 Pasteur Institute of Iran (IPI) Comparing the Efficacy and Safety of Hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in Iranian healthy volunteers Comparing the Efficacy and Safety of Hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in Iranian healthy volunteers 2011-09-23 anticipated 440 Complete https://irct.ir/trial/3379 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2 Condition 1: Acute Hepatitis B. Condition 2: Chronic (viral) hepatitis B. Intervention 1: Hepatitis B vaccine produced by Pasteur Institute of Iran (intervention group) in 3 course. Month 0, month 1 and month 6. Intervention 2: Hepatitis B vaccine produced by Heber Biotech Institute of Cuba (Control group) in 3 course. month 0, month 1, and month six.
public Mostafa Shafiei
Tehran
Tehran Iran (Islamic Republic of) +98 912 550 8701 m.shafiei@brcgl.com Baqiyatallah Research Center for Gastroenterology and Liver Diseases scientific Sayed Moayed Alavian
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
Tehran Iran (Islamic Republic of) +98 21 8861 4523 editor@hepatmon.ir Baqiyatallah Research Center for Gastroenterology and Liver Diseases Iran (Islamic Republic of) Inclusion criteria: Healthy volunteers completed inform consent Exclusion criteria: HBsAg+ or HBcAb+ patients Previous incubation of hepatitis B vaccine or serum HBsAb >10 mIU/ml before the first dose of vaccine incubation Patients with: Thalassemia, any malignancies, Immunodeficiency, HIV, DM, Liver failure and dialysis patients no limit no limit Both B16 B18.1 Acute hepatitis B Chronic (viral) hepatitis B Prevention Prevention Hepatitis B vaccine produced by Pasteur Institute of Iran (intervention group) in 3 course. Month 0, month 1 and month 6. Hepatitis B vaccine produced by Heber Biotech Institute of Cuba (Control group) in 3 course. month 0, month 1, and month six. HBsAb serum titre. Timepoint: Respectively, one, six and seven month after incubation of first vaccine. Method of measurement: ELISA test. Vaccination adverse events. Timepoint: Respectively, one, six and seven month after incubation of first vaccine. Method of measurement: Based on history and measured blood biochemical variables. Pasteur Institute of Iran (IPI) Approved 2010-02-28 Ethics committee of Baqyatallah University of Medical Sciences Baqyatallah University of Medical Sciences, Mollasdra Ave., Vanak Squ Tehran Iran (Islamic Republic of)