title: Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: results of a randomised controlled trial.
abstract: We evaluated safety and immunogenicity of two orally administered human rotavirus vaccine candidates 116E and I321. Ninety healthy infants aged 8 weeks received a single dose of 116E (10(5)FFu (florescence focus units)), I321 (10(5)FFu) or placebo. There were no significant differences in the number of adverse events. Fever was reported by 6/30, 1/30 and 5/30 in the 116E, I321 and placebo groups; the corresponding figures for diarrhoea were 5/30, 8/29 and 3/30. Serum IgA seroconversion rates were 73%, 39% and 20% in the 116E, I321 and placebo groups, respectively. Vaccine virus was shed on days 3, 7 or 28 in 11/30 infants of the 116E and none in the other two groups. The 116E strain is attenuated, clinically safe and highly immunogenic with a single dose.
authors.affiliation: Society for Applied Studies, New Delhi, India.
authors.forename: Nita
authors.initials: N
authors.lastname: Bhandari
authors.forename: Pooja
authors.initials: P
authors.lastname: Sharma
authors.forename: Roger I
authors.initials: RI
authors.lastname: Glass
authors.forename: Pratima
authors.initials: P
authors.lastname: Ray
authors.forename: Harry
authors.initials: H
authors.lastname: Greenberg
authors.forename: Sunita
authors.initials: S
authors.lastname: Taneja
authors.forename: Manju
authors.initials: M
authors.lastname: Saksena
authors.forename: C Durga
authors.initials: CD
authors.lastname: Rao
authors.forename: Jon R
authors.initials: JR
authors.lastname: Gentsch
authors.forename: Umesh
authors.initials: U
authors.lastname: Parashar
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Maldonado
authors.forename: Richard L
authors.initials: RL
authors.lastname: Ward
authors.forename: M K
authors.initials: MK
authors.lastname: Bhan
mesh_terms: D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012401:Rotavirus / Q000235:genetics / Q000276:immunology*; D012400:Rotavirus Infections / Q000235:genetics / Q000276:immunology / Q000517:prevention & control; D022243:Rotavirus Vaccines / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*
chemical_list: D022243:Rotavirus Vaccines