RESUMO
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.
Assuntos
Vacina BCG/administração & dosagem , Anticorpos Anti-Hepatite B/sangue , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/imunologia , Vírus da Hepatite B/imunologia , Hepatite B/imunologia , Vacinação , Feminino , Hepatite B/sangue , Antígenos de Superfície da Hepatite B/imunologia , Vacinas contra Hepatite B/efeitos adversos , Humanos , Esquemas de Imunização , Recém-Nascido , Injeções Intradérmicas , Masculino , Estudos Prospectivos , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/imunologiaRESUMO
Cell-mediated immune responses to BCG vaccine were evaluated in 7-month-old infants vaccinated with intradermal combined BCG and Hepatitis B or intradermal BCG and intramuscular Hepatitis B at birth. Peripheral blood mononuclear cell cultures from both groups showed CD4(+), CD8(+) and remarkable gammadelta(+) T cell BCG-specific proliferation, without significant differences. Also, IL-10, IL-12, IFN-gamma and TNF-alpha concentrations in culture supernatants, measured by ELISA, were similar. The results suggested that the combined BCG and Hepatitis B vaccine was as immunogenic as BCG separated from Hepatitis B vaccine.
