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Title: A phase I clinical trial of a new 5-valent rotavirus vaccine
Authors: LUNA, Expedito J. A.FRAZATTI-GALLINA, Neuza M.TIMENETSKY, Maria C. S. T.CARDOSO, Maria R. A.VERAS, Maria A. S. M.MIRAGLIA, Joao L.ESCOBAR, Ana M. U.GRISI, Sandra J. F. E.RAW, IsaiasPRECIOSO, Alexander R.
Citation: VACCINE, v.31, n.7, p.1100-1105, 2013
Abstract: We conducted a phase I, double-blind, placebo-controlled trial to evaluate a new 5-valent oral rotavirus vaccine's safety and immunogenicity profiles. Subjects were randomly assigned to receive 3 orally administered doses of a live-attenuated human-bovine (UK) reassortant rotavirus vaccine, containing five viral antigens (G1, G2, G3, G4 and G9), or a placebo. The frequency and severity of adverse events were assessed. Immunogenicity was evaluated by the titers of anti-rotavirus IgA and the presence of neutralizing antibodies anti-rotavirus. No severe adverse events were observed. There was no difference in the frequency of mild adverse events between experimental and control groups. The proportion of seroconversion was consistently higher in the vaccine group, for all serotypes, after each one of the doses. The 5-valent vaccine has shown a good profile of safety and immunogenicity in this small sample of adult volunteers.
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Artigos e Materiais de Revistas Científicas - FM/MPE
Departamento de Pediatria - FM/MPE

Artigos e Materiais de Revistas Científicas - HC/ICr
Instituto da Criança - HC/ICr

Artigos e Materiais de Revistas Científicas - IMT
Instituto de Medicina Tropical - IMT

Artigos e Materiais de Revistas Científicas - LIM/21
LIM/21 - Laboratório de Neuroimagem em Psiquiatria

Artigos e Materiais de Revistas Científicas - LIM/52
LIM/52 - Laboratório de Virologia

Artigos e Materiais de Revistas Científicas - ODS/03
ODS/03 - Saúde e bem-estar

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