Navegando por Autor "OLIVEIRA, Consuelo Silva de"

Agora exibindo 1 - 3 de 3

Acesso aberto (Open Access)
Eficácia clínica da vacina tetravalente (RRV-TV) contra rotavírus em Belém, Pará
(Universidade Federal do Pará, 1999-06-17) OLIVEIRA, Consuelo Silva de; LINHARES, Alexandre da Costa; http://lattes.cnpq.br/3316632173870389; BATISTA, Nildo Alves; http://lattes.cnpq.br/9347541615414055
There is currently growing evidence that infantile rotavirus gastroenteritis will be controlled only through the development of an effective vaccine targeted for use in early childhood. This study was conducted with the aim of assessing the protective efficacy of the lower-titer rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV, 4 x 104 ) against the major clinical indicators of severity cases of rotavirus diarrhoea; for this, were re-examined 91 rotavirus-associated diarrhoeal episodes that were recorded during an efficacy trial carried out previously in Belem, Para, Brazil. The source of information for study were the data recorded in field forms used to perform the routine surveillance for diarrhoeal episodes, as well as those forms in which daily clinical records were made while diarrhoea persisted. Relative efficacy was specifically against the following clinical parameters: a) duration of diarrhoea; b) maximum number of liquid /semiliquid stools per day; c) duration of vomiting episodes/24h; d) maximum number of vomiting episodes / 24h; e) fever (rectal temperature); f) dehydration; and g) need for treatment. The overall clinical severity of rotavirus gastroenteritis has been graded using a numerical twenty-point scoring system (i.e., maximum of 20 points) which allowed the classification of diarrhoeal cases in mild (0-6 scoring interval), moderate/severe (9- 14) and very severe (>14). A significant (p<0.05) protection conferred by RRV-TV was observed in five of the seven clinical parameters under analysis, as follows: a) duration of diarrhoea (52%, pure rotavirus diarrhoea; b) maximum number of liquid/semi-liquid stools per day (42% and 53% against all- and- pure diarrhoeal episodes, respectively); c) maximum number of vomiting (56% and 62% for all-andpure diarrhoeal cases, respectively); d) dehydration (42% and 48% against all-andpure cases of diarrhoea, respectively); and e) the need for rehidration (42% and 46% for all-and-pure cases, respectively). High protective efficacy levels were achieved against rotavirus type G2-related diarrhoea during the second year of follow-up, if considered both the number-and-the maximum number vomiting episodes: 90% and 100%, respectively. Also for G2 type, the overall cumulative protection of 100% against those episodes scored greater than 14. Similar rates of protection against mixed - (35%) and - pure (37%) rotavirus gastroenteritis were yielded after two years of follow-up. While no efficacy was achieved against mild (0- 8 scored) diarrhoea, RRV-TV was 75% (p = 0.02) efficacious against the very severe cases of rotavirus gastroenteritis; there was a tendency for protection against alland- pure diarrhoeal episodes with clinical scores ranging from 9 to 14: 44% (p = 0.06) and 45% (p = 0.08), respectively. The results of study support the view that RRV-TV appears to selectively protect against the most severe rotavirus disease.
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.