Immunogenicity and safety of combined intradermal recombinant Hepatitis B with BCG vaccines at birth.

Author(s): Carniel EF, Morcillo AM, Blotta MH, Da Silva MT, Mazzola TN, Antonio MA, Zanolli ML, Netto AA, Higashi HG, Raw I, Vilela MM

Affiliation(s): Center for Investigation in Pediatrics, Pediatrics Department, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo, 126, Campinas, Sao Paulo, CEP 13083-887, Brazil. carniel@fcm.unicamp.br <carniel@fcm.unicamp.br>

Publication date & source: 2008-01-30, Vaccine., 26(5):647-52. Epub 2007 Dec 7.

Publication type: Clinical Trial; Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

This randomized, prospective, non-inferiority study aimed to quantify anti-HBs titers induced by recombinant Hepatitis B vaccine from healthy infants vaccinated with combined Hepatitis B and Bacillus Calmette-Guerin (BCG) vaccines (HbsAg 10 microg plus BCG suspension 0.1mg) and compare them to titers obtained with separated vaccines. Infants were immunized at birth either with combined intradermal (ID) BCG and Hepatitis B or ID BCG alone and intramuscular (IM) Hepatitis B. Both groups received IM Hepatitis B at 1 and 6 months of age. After the third dose anti-HBs titers > or =10 IU/mL were observed in 99% of vaccinees and > or =1000 IU/mL in 71%. There were no adverse events in both groups. Combination of HbsAg with BCG as first dose did not modify the profile of the humoral immune response for Hepatitis B indicating safety and immunogenicity of this vaccine in newborn.