Ensaio clínica controlado e randomizado para avaliar a imunogenicidade e reatogenicidade da vacina contra hepatite B (butang(R)) aplicada em recém-nascidos na região glútea ou vasto lateral da cocha

• Ano de defesa: 2009
• Autor(a) principal: JUNQUEIRA, Ana Luiza Neto
• Orientador(a): TELES, Sheila Araújo
• Tipo de documento: Tese
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de Goiás
• Programa de Pós-Graduação: Doutorado em Ciencias da Saude
• Departamento: Ciencias da Saude
• País: BR
• Palavras-chave em Português: vacina contra hepatite B; recém-nascido; lactentes; ventro glútea e vasto lateral da coxa
• Palavras-chave em Inglês: hepatitis B vaccine; newborn, infant; ventrogluteal; anterolateral thigh muscle
• Área do conhecimento CNPq: CNPQ::CIENCIAS DA SAUDE
• Link de acesso: http://repositorio.bc.ufg.br/tede/handle/tde/1505

This study is the first randomized controlled clinical trial for assessing the immunogenicity and reatogenicity of the Butang® vaccine in full term newborns, who were given the first vaccine dose within the first 12 hours of life, comparing two regions of application for the vaccine: anterolateral thigh (ALT) and ventrogluteal (VG). Butang® response was assessed in 224 newborns who were given the vaccine in the VG region and 250 in the ALT one. Both groups were similar regarding gender, weight, timing interval between doses of the vaccine and maternal characteristics. When comparing Butang® immunogenicity, we verified that the proportion of babies who developed anti-HBs protecting titres after three vaccine doses in the VG region was of 97.8% (IC 95%: 94.8 99.3) with geometric mean titer (GMT) of 427.5 mUI/mL (IC 95%: 344.9 530.0), similar to those who were given in the ALT region (97.6%; IC 95%: 94.8 99.1; GMT: 572.0 mUI/mL; IC 95%: 471.1 694.6), which provides evidence that this place is appropriate for hepatitis B vaccination. Eleven newborns did not respond to Butang®, being six of them vaccinated in the VG region and five in the ALT. The most of them were male, one factor which seems to interfere with hepatitis B vaccine response. We verified an increasing proportion of local reactions and fever according to the number of doses given. In addition, after the third dose the proportion of induration (4.0 vs. 11.4) was higher among babies who were given the vaccine in the ALT region when compared to those who were given in the VG region (p < 0,05). No association was observed concerning maternal anti-HBs titres and newborn vaccine response. The evidences of this study showed that the VG region is a safe and immunogenic site to hepatitis B vaccine administration in newborns.