Navegando por Autor "MASCARENHAS, Joana D'Arc Pereira"

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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)
Sapoviruses in children with acute gastroenteritis from Manaus, Amazon region, Brazil, 2010-2011
(Universidade Federal do Pará, 2016-11-03) REYMÃO, Tammy Kathlyn Amaral; HERNANDEZ, Juliana das Merces; COSTA, Samya Thalita Picanço da; SOUSA, Maisa Silva de; OLIVEIRA, Darleise de Souza; SILVA, Luciana Damascena da; BANDEIRA, Renato da Silva; LIMA, Ian Carlos Gomes de; SOARES, Luana da Silva; MASCARENHAS, Joana D'Arc Pereira; GABBAY, Yvone Benchimol
Sapoviruses (SaVs) are responsible for acute gastroenteritis in humans, especially children and the elderly. In Brazil, data on SaVs infections are very limited, especially in Northern Brazil. Here, we investigated the occurrence of SaVs in samples from hospitalized children under ten years old that presented acute gastroenteritis. Positive samples were genotyped and phylogenetic analysis was performed using prototype strains sequences obtained from GenBank database. In total, 156 fecal samples were screened by RT-PCR for SaVs. A positivity rate of 3.8% (6/156) was found in children under three years of age. Four genotypes were detected: GI.I, GI.2 and GII.2?-GII.4?/GII.4, suggesting a possible inter-genotypes recombination. Most infections (83.3%) occurred between August and September. The positivity was similar to that found in other countries and genotyping demonstrated the presence of distinct genotypes. To our knowledge, this is the first study reporting the circulation of SaVs in Manaus, state of Amazonas, Amazon region, Brazil.
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.