Oral live attenuated human rotavirus vaccine (RotarixTM) offers sustained high protection against severe G9P[8] rotavirus gastroenteritis during the first two years of life in Brazilian children

Memórias do Instituto Oswaldo Cruz

Maria Cleonice A Justino²  Eliete C Araújo¹  Leen-jan Van Doorn¹  Consuelo S Oliveira²  Yvone B Gabbay²  Joana D'arc P Mascarenhas²  Yllen S Miranda²  Sylvia De Fátima S Guerra²  Veronilce B Da Silva²  Alexandre C Linhares² 

[1] ,Secretaria de Vigilância em Saúde Instituto Evandro Chagas Belém PA ,Brasil

关键词: rotavirus;    gastroenteritis;    vaccine efficacy;    G9P[8] strains;   

DOI  :  10.1590/S0074-02762012000700002

来源: SciELO

【 摘 要 】

In a large Phase III trial conducted in 10 Latin American countries, the safety and efficacy of the live attenuated monovalent rotavirus vaccine RIX4414 was evaluated in 15,183 healthy infants followed up during the first two years of life. Belém was the only site in Brazil included in this multicentre trial. The study in Belém included a subset of 653 infants who were followed up until 24 months of age for protection against severe rotavirus gastroenteritis. These subjects were randomly assigned in a 1:1 ratio to receive two doses of vaccine (n = 328) or two doses of placebo (n = 325) at approximately two and four months of age. Of the 653 enrolled infants, 23 dropped out during the study period. For the combined two-year period, the efficacy of RIX4414 was 72.3% [95% confidence interval (CI) 37.5-89.1%] against severe rotavirus-related gastroenteritis, reaching a protection rate of 81.8% (95% CI 36.4-96.6%) against circulating wild-type G9 rotavirus strains. It is concluded that two doses of RIX4414 are highly efficacious against severe rotavirus gastroenteritis in Belém during the first two years of life and provide high protection against the worldwide emergence and spread of G9P[8] strains.

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