Navegando por Autor "JUSTINO, Maria Cleonice Aguiar"

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Eficácia e segurança de uma vacina oral de rotavírus humano atenuado contra gastroenterite grave por rotavírus, durante os primeiros dois anos de vida em crianças em Belém, Pará, Brasil
(Universidade Federal do Pará, 2009) JUSTINO, Maria Cleonice Aguiar; ARAÚJO, Eliete da Cunha; http://lattes.cnpq.br/5906453187927460; LINHARES, Alexandre da Costa; http://lattes.cnpq.br/3316632173870389
Rotaviruses are recognised as the leading cause of severe gastroenteritis in children aged less than five years in both developed and developing countries, with highest incidence rates between 6 and 24 months of life. On a global scale, recent estimates indicate that annually rotaviruses cause at least 500,000 deaths. A large phase III clinical trial was undertaken in 11 Latin American countries and Finland with an attenuated, human-derived vaccine strain, including recruitment of more than 63,000 children. This was a randomised, double-blind, placebo-controlled trial in which more than 63,000 infants were randomly assigned to receive two oral doses of either RIX4414 or placebo at a proportion of 1:1. The main purposed of this study was to evaluate both protective efficacy and safety of RIX4414. As part of the original study, 3,218 children were enrolled in Belém, Pará, to whom two doses of either vaccine or placebo were administered at 2 and 4 months of age. A subset of infants (n = 653) was evaluated throughout 1 – 2 years in order to assess efficacy of RIX4414 vaccine. Overall, 37 gastroenteritis episodes of severe rotavirus gastroenteritis were recorded of which 75.6% (28/37) and 24% (9/37) in the placebo and vaccine recipients, respectively. The level of rotavirus vaccine protection was higher [83% (CI95% 22 – 96)] against very severe rotavirus gastroenteritis, yielding a ≥ 15 score as calculated with a 20-point Ruuska & Vesikari scale. The cumulative hazard of a first episode of severe gastroenteritis was about four-fold lower in the vaccine group throughout the 2-years’ efficacy period, as compared to the placebo group. The protection rates against severe gastroenteritis caused by G1- and- non-G1 serotypes were 51% (CI95% -30-81) and 82% (CI95% 37-95), respectively, denoting efficacies against rotavirus strains both homologous and heterologous to the vaccine strain. Of importance, the vaccine afforded significant protection [93% (CI95%47-99)] against G9 serotype which has been regarded as a globally emergent strain, besides of being related to more severe gastroenteritis. Also reflecting a vaccine efficacy, there was a significant reduction, by 35.3% (CI95% 11.6-52.9), in the rate of allcause hospitalisation for gastroenteritis, a finding of potential major public health impact. With regards to safety of RIX4414 vaccine, there were no overall statistically significant differences when the rates of serious adverse events were compared for vaccine group and placebo group. No cases of intussusception were reported during the entire follow-up period, through broad and active surveillance in paediatric clinics in the study area. Results obtained in this study confirm previous findings from worldwide several multi-centric trials that sustain both protective efficacy and safety of RIX4414 when administered in a 2-dose schema to healthy infants.
Acesso aberto (Open Access)
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
(2012-11) JUSTINO, Maria Cleonice Aguiar; ARAÚJO, Eliete da Cunha; VAN DOORN, Leen-Jan; OLIVEIRA, Consuelo Silva de; GABBAY, Yvone Benchimol; MASCARENHAS, Joana D'Arc Pereira; MIRANDA, Yllen Stefania Affonso; GUERRA, Sylvia de Fátima dos Santos; SILVA, Veronilce Borges da; LINHARES, Alexandre da Costa
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.
Acesso aberto (Open Access)
Segurança, imunogenicidade e eficácia protetora de duas doses da vacina RIX4414 contendo rotavírus atenuado de origem humana
(2007-06) ARAÚJO, Eliete da Cunha; CLEMENS, Sue Ann C.; OLIVEIRA, Consuelo Silva de; JUSTINO, Maria Cleonice Aguiar; RUBIO, Pilar; GABBAY, Yvone Benchimol; SILVA, Veronilce Borges da; MASCARENHAS, Joana D'Arc Pereira; CAVALCANTE, Vânia Lúcia Noronha; CLEMENS, Ralf; GUSMÃO, Rosa Helena Porto; SANCHEZ, Nervo; MONTEIRO, Talita Antonia Furtado; LINHARES, Alexandre da Costa
Objective: To determine the safety, immunogenicity and efficacy of two doses of rotavirus vaccine in healthy Brazilian infants. Methods: A randomized, multicenter, double-blind, placebo-controlled trial was conducted in Brazil, Mexico and Venezuela. Infants received two oral doses of vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for oral poliomyelitis vaccine (OPV). This paper reports results from Belém, Brazil, where the number of subjects per group and the viral vaccine titers were: 194 (104.7 focus forming units – FFU), 196 (105.2 FFU), 194 (105.8 FFU) and 194 (placebo). Anti-rotavirus (anti-RV) antibody response was assessed in 307 subjects. Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of ≥ 11 defined as severe GE. Results: The rates of solicited general symptoms were similar in vaccine and placebo recipients. At 2 months after the second dose, a serum IgA response to RV occurred in 54.7 to 74.4% of vaccinees. No interference was seen in the immunogenicity of routine vaccines. Vaccine efficacy against any rotavirus gastroenteritis (RVGE) was 63.5% (95%CI 20.8-84.4) for the highest concentration (105.8 FFU). Efficacy was 81.5% (95%CI 44.5-95.4) against severe RVGE. At its highest concentration (105.8 FFU), RIX4414 provided 79.8% (95%CI 26.4-96.3) protection against severe RVGE by G9 strain. Conclusions: RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diptheria, tetanus, pertussis, hepatitis B and Hib antigens. Two doses of RIX4414 provided significant protection against severe GE caused by RV.