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Kusnandi Rusmil

Sadikin General Hospital, Indonesia

Biography

Hepatitis B is one of the most common infectious diseases. Two billion people worldwide have serologic infections, while 350 million are chronically infected and at risk for HBV-related liver disease. Indonesia has moderate–high (9.4%) endemicity for hepatitis B infection. 90% of infants infected with HBV are due to perinatal transmission, 30-50% of HBV-infected children under 5 years old are known to be Hepatitis B carrier, and 6-10% of HBV-infected adult are suffering from chronic liver diseases. Hepatitis B immunization is recommended for infants after birth.

Several studies have reviewed the immunogenicity and safety of hepatitis B vaccine (Bio FarmaÒ), such as in early age group in 2003–2004, in adolescent in 2012, used in combination with pentavalent vaccine in 2013, and booster continuation at the age of 18–24 months in 2014. Clinical trial studies of 3-doses of monovalent hepatitis B vaccine in children receiving basic immunization, and additional 3-doses monovalent hepatitis B vaccine in hypo-/non-responder children receiving basic immunization have shown that all children achieved level of anti-Hbs titer >10 mIU/mL. Three doses of monovalent hepatitis B vaccine given to adolescent who had never been immunized before proven to be safe and provide immunity.

Basic and booster immunization of hepatitis B combination/pentavalent (DPT-HB-Hib) at 18–24 months has been proven to be safe and provide the immunogenicity. Hepatitis B vaccine manufactured by Bio Farma Inc., given during basic and booster immunization, including the monovalent and combination vaccine, have been shown to be safe and provide good immunogenicity.

 

Abstract

Abstract : Clinical Trials of Hepatitis B Vaccine