Development of Candidate Rotavirus Vaccines Derived from Neonatal Strains in India
1Respiratory and Enteric Viruses Branch, Centers for Disease Control and Prevention, Atlanta, Georgia; 2Stanford University Medical School, Palo Alto, California; 3Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; 4Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, and 5India Institute of Science, Bangalore, India
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.
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Financial support: Bill and Melinda Gates Foundation (to the Program for Appropriate Technology in Health, through the Andra Pradesh Initiative); National Institutes of Health (grants AI‐21362 and AI‐53719); Department of Biotechnology of the Government of India; Indo‐US Vaccine Action Program.
Potential conflicts of interest: none reported.





