A phase I clinical trial of a new 5-valent rotavirus vaccine

作者：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 Isaias; Precioso Alexander R

来源：Vaccine, 2013, 31(7): 1100-1105.

DOI：10.1016/j.vaccine.2012.12.020

• Rotavirus
• Vaccine
• Clinical trial
• Safety
• Immunogenicity

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.

• 出版日期2013-2
• 单位河北医科大学