title: Development of candidate rotavirus vaccines derived from neonatal strains in India.
abstract: The need for a rotavirus vaccine in India is based on the enormous burden associated with the >100,000 deaths due to rotavirus diarrhea that occur annually among Indian children. Two rotavirus strains identified during nosocomial outbreaks of rotavirus infection in New Delhi and Bangalore, India, more than a decade ago are being developed as live oral vaccines. Infected newborns had no symptoms, shed virus for up to 2 weeks after infection, mounted a robust immune response, and demonstrated protection against severe rotavirus diarrhea after reinfection. The 2 strains are naturally occurring bovine-human reassortants. The New Delhi strain, 116E, is characterized as having a P[11],G9 genotype, and the Bangalore strain, I321, is characterized as having a P[11],G10 genotype. The strains have been prepared as pilot lots for clinical trials to be conducted in New Delhi. This unique project, which is developing a new rotavirus vaccine in India with the use of Indian strains, an Indian manufacturer, and an Indian clinical development program, aims to expedite introduction of rotavirus vaccines in India.
authors.affiliation: Respiratory and Enteric Viruses Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. rglass@cdc.gov
authors.forename: Roger I
authors.initials: RI
authors.lastname: Glass
authors.forename: Maharaj K
authors.initials: MK
authors.lastname: Bhan
authors.forename: Pratima
authors.initials: P
authors.lastname: Ray
authors.forename: Rajiv
authors.initials: R
authors.lastname: Bahl
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
authors.forename: Harry
authors.initials: H
authors.lastname: Greenberg
authors.forename: C Durga
authors.initials: CD
authors.lastname: Rao
authors.forename: Nita
authors.initials: N
authors.lastname: Bhandari
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Maldonado
authors.forename: Richard L
authors.initials: RL
authors.lastname: Ward
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Jon R
authors.initials: JR
authors.lastname: Gentsch
mesh_terms: D000284:Administration, Oral; D002986:Clinical Trials as Topic; D003967:Diarrhea / Q000453:epidemiology / Q000517:prevention & control*; D004196:Disease Outbreaks; D005814:Genes, Viral; D006801:Humans; D007194:India / Q000453:epidemiology; D007231:Infant, Newborn; D016865:Reassortant Viruses / Q000235:genetics / Q000276:immunology*; D012401:Rotavirus / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage
chemical_list: D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated