Document Detail

Comparative study of a whole-cell pertussis vaccine and a recombinant acellular pertussis vaccine. The Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine.
MedLine Citation:
PMID:  8201477     Owner:  NLM     Status:  MEDLINE    
The safety and immunogenicity of an acellular pertussis vaccine containing the genetically detoxified pertussis toxin PT-9K/129G, filamentous hemagglutinin, and pertactin, together with diphtheria and tetanus toxoids, were compared with those of a whole-cell pertussis component-diphtheria-tetanus vaccine. Four hundred eighty infants were enrolled into this prospective, multicenter, double-blind study. Each infant was randomly given three doses of one of the two vaccines at 2, 4, and 6 months of age. Both local and systemic adverse reactions, reported within 48 hours and 7 days of each injection, were less frequent after the acellular vaccine than after the whole-cell vaccine. The enzyme-linked immunosorbent assay titers to pertussis toxin, filamentous hemagglutinin, and pertactin, as well as the pertussis toxin-neutralizing titer measured by the Chinese hamster ovary cell assay, were significantly higher after the acellular vaccine was given. Both vaccines induced adequate levels of anti-diphtheria and anti-tetanus antibodies. We conclude that the recombinant acellular pertussis vaccine produces fewer reactions than the whole-cell vaccine and provides a high antibody response against the antigens of Bordetella pertussis involved in bacterial adhesion and systemic toxic effects.
A Podda; E C De Luca; B Contu; R Furlan; A Maida; A Moiraghi; D Stramare; L Titone; F Uxa; F Di Pisa; S Peppoloni
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of pediatrics     Volume:  124     ISSN:  0022-3476     ISO Abbreviation:  J. Pediatr.     Publication Date:  1994 Jun 
Date Detail:
Created Date:  1994-07-06     Completed Date:  1994-07-06     Revised Date:  2009-12-01    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  921-6     Citation Subset:  AIM; IM    
Biocine R & D Vaccines, Siena, Italy.
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MeSH Terms
Antibodies, Bacterial / biosynthesis
Bordetella pertussis / immunology*
Diphtheria-Tetanus-Pertussis Vaccine* / adverse effects,  immunology
Double-Blind Method
Pertussis Vaccine* / adverse effects,  immunology
Prospective Studies
Vaccines, Synthetic / adverse effects,  immunology
Reg. No./Substance:
0/Antibodies, Bacterial; 0/Diphtheria-Tetanus-Pertussis Vaccine; 0/Pertussis Vaccine; 0/Vaccines, Synthetic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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