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IRCT2014051015999N2 IRCT 2014-08-06 Vice Chancellor for Research Isfahan University of Medical Sciences Effect of Tetanus-diphtheria vaccine in promotion of immune response against hepatitis B vaccine Comparison of immune response to hepatitis B vaccine in simultaneous injections of Tetanus-diphtheria and B hepatitis vaccines with hepatitis B vaccine alone in Azahra staff having anti-HBs Ab lower than 100 IU/ml 2013-02-14 anticipated 280 Complete https://irct.ir/trial/15098 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 Hepatitis B. Intervention 1: Intervention 1: This intervention was implemented by 40 microgram of rHBsAg produced by CUBA-SIA Company, while Tetanous-diphteria vaccine (Td [0.5ml of toxoid produced at Pasteur Institute]) was simultaneously injected in the first application of rHBsAg in two different sites and the former vaccination continued one and six months later. All of the vaccination programs were implemented through intramuscular injections. Intervention 2: Intervention 2: 40 microgram of recombinant HBsAg (rHBsAg) produced by CUBA-SIA company in months of 0, 1 and 6.
public Roya Taleban
Community Medicine Department, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Ave., ŮŽAzadi Sq.
Isfahan Iran (Islamic Republic of) +98 31 3792 2542 r.taleban@med.mui.ac.ir Isfahan University of Medical Sciences scientific Mohammad Moafi
Bu-Ali Sina University, Hamadan,Iran
Hamadan Iran (Islamic Republic of) +98 913 113 0938 mohammoafi@yahoo.com Bu-Ali Sina University Iran (Islamic Republic of) Inclusion Criteria: Individuals being Hepatitis B Antigen (HBsAg) negative whilst they were vaccinated against B hepatitis and their antibody titers would be lower than 100 IU/ml. Lack of primary or acquired immune deficiency Exclusion criteria: Individuals will be excluded from the study and they will be treated if their status of hypersensitivity is recognized. 20 years 65 years Both B18 Chronic viral hepatitis Prevention Prevention Intervention 1: This intervention was implemented by 40 microgram of rHBsAg produced by CUBA-SIA Company, while Tetanous-diphteria vaccine (Td [0.5ml of toxoid produced at Pasteur Institute]) was simultaneously injected in the first application of rHBsAg in two different sites and the former vaccination continued one and six months later. All of the vaccination programs were implemented through intramuscular injections. Intervention 2: 40 microgram of recombinant HBsAg (rHBsAg) produced by CUBA-SIA company in months of 0, 1 and 6 Hepatitis B Antibody titer. Timepoint: 1 and 6 months after vaccination. Method of measurement: By ELISA method. Vice Chancellor for Research Isfahan University of Medical Sciences Approved 2013-01-14 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq. Isfahan Iran (Islamic Republic of)