Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b

Memórias do Instituto Oswaldo Cruz

Reinaldo De Menezes Martins¹  Luiz Antonio Bastos Camacho²  Rugimar Marcovistz¹  Tatiana Guimarães De Noronha¹  Maria De Lourdes Sousa Maia¹  Eliane Matos Dos Santos¹  Glayse Glayde Barbosa¹  Andrea Marques Vieira Da Silva¹  Patricia Cristina Neves Feliciano De Souza¹  Maria Cristina Ferreira Lemos¹  Akira Homma¹ 

[1] ,Fiocruz Escola Nacional de Saúde Pública

关键词: vaccines;    immunization;    combination vaccines;    DTP/Hib vaccine;   

DOI  :  10.1590/S0074-02762008000700014

来源: SciELO

【 摘 要 】

A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6% and 98.4% of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100% seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7%, 100% and 99.9%, respectively, for DTP/Hib-BM, three lots altogether and 99.2%, 100% and 100% for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.

【 授权许可】

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