title: A phase I clinical trial of a new 5-valent rotavirus vaccine.
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.
authors.affiliation: Instituto de Medicina Tropical, Universidade de São Paulo, Brazil. eluna@usp.br
authors.forename: Expedito J A
authors.initials: EJ
authors.lastname: Luna
authors.forename: Neuza M
authors.initials: NM
authors.lastname: Frazatti-Gallina
authors.forename: Maria C S T
authors.initials: MC
authors.lastname: Timenetsky
authors.forename: Maria R A
authors.initials: MR
authors.lastname: Cardoso
authors.forename: Maria A S M
authors.initials: MA
authors.lastname: Veras
authors.forename: João L
authors.initials: JL
authors.lastname: Miraglia
authors.forename: Ana M U
authors.initials: AM
authors.lastname: Escobar
authors.forename: Sandra J F E
authors.initials: SJ
authors.lastname: Grisi
authors.forename: Isaias
authors.initials: I
authors.lastname: Raw
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Precioso
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D007070:Immunoglobulin A; D010919:Placebos; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated