title: Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b.
abstract: 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 (> or =0.15 microg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 microg/mL, 10.3 microg/mL and 10.3 microg/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.
authors.affiliation: Assessoria Clínica, Rio de Janeiro, RJ, Brasil. rmenezes@bio.fiocruz.br
authors.forename: Reinaldo de Menezes
authors.initials: Rde M
authors.lastname: Martins
authors.forename: Luiz Antonio Bastos
authors.initials: LA
authors.lastname: Camacho
authors.forename: Rugimar
authors.initials: R
authors.lastname: Marcovistz
authors.forename: Tatiana Guimarães de
authors.initials: TG
authors.lastname: Noronha
authors.forename: Maria de Lourdes Sousa
authors.initials: Mde L
authors.lastname: Maia
authors.forename: Eliane Matos
authors.initials: EM
authors.lastname: dos Santos
authors.forename: Glayse Glayde
authors.initials: GG
authors.lastname: Barbosa
authors.forename: Andrea Marques Vieira da
authors.initials: AM
authors.lastname: Silva
authors.forename: Patricia Cristina Neves Feliciano de
authors.initials: PC
authors.lastname: Souza
authors.forename: Maria Cristina Ferreira
authors.initials: MC
authors.lastname: Lemos
authors.forename: Akira
authors.initials: A
authors.lastname: Homma
mesh_terms: D001886:Bordetella pertussis / Q000276:immunology; D003017:Clostridium tetani / Q000276:immunology; D003353:Corynebacterium diphtheriae / Q000276:immunology; D004165:Diphtheria / Q000517:prevention & control*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology; D006801:Humans; D007223:Infant; D008297:Male; D013742:Tetanus / Q000517:prevention & control*; D013997:Time Factors; D014917:Whooping Cough / Q000517:prevention & control*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine