title: Immunogenicity and safety of combined intradermal recombinant Hepatitis B with BCG vaccines at birth.
abstract: 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-Guérin (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.
authors.affiliation: Center for Investigation in Pediatrics, Pediatrics Department, State University of Campinas Medical School, Rua Tessália Vieira de Camargo, 126, Campinas, São Paulo, CEP 13083-887, Brazil. carniel@fcm.unicamp.br <carniel@fcm.unicamp.br>
authors.forename: E F
authors.initials: EF
authors.lastname: Carniel
authors.forename: A M
authors.initials: AM
authors.lastname: Morcillo
authors.forename: M H
authors.initials: MH
authors.lastname: Blotta
authors.forename: M T N
authors.initials: MT
authors.lastname: Da Silva
authors.forename: T N
authors.initials: TN
authors.lastname: Mazzola
authors.forename: M A R G M
authors.initials: MA
authors.lastname: Antonio
authors.forename: M L
authors.initials: ML
authors.lastname: Zanolli
authors.forename: A Aranha
authors.initials: AA
authors.lastname: Netto
authors.forename: H G
authors.initials: HG
authors.lastname: Higashi
authors.forename: I
authors.initials: I
authors.lastname: Raw
authors.forename: M M S
authors.initials: MM
authors.lastname: Vilela
mesh_terms: D001500:BCG Vaccine / Q000008:administration & dosage*; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007231:Infant, Newborn; D007271:Injections, Intradermal; D008297:Male; D011446:Prospective Studies; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D001500:BCG Vaccine; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D014614:Vaccines, Synthetic