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

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 mu g plus BCG suspension 0.1 mg) 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 >= 10 IU/mL were observed in 99% of vaccinees and >= 1000IU/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. (c) 2007 Elsevier Ltd. All rights reserved.