Drug intelligence / Profile preview

rotavirus vaccine I321

Development stage
Phase 1
Lead developer
Bharat Biotech
Modality
Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

Rotavirus vaccine I321 is a live attenuated oral vaccine candidate developed by the Society for Applied Studies for the prevention of rotavirus infection. The vaccine is based on the I321 strain, a naturally occurring bovine-human reassortant (P[11],G10 genotype) isolated from a nosocomial outbreak among neonates in Bangalore, India. The strain is composed primarily of bovine genes with two human-origin gene segments encoding nonstructural proteins. In Phase I clinical trials conducted in India, the vaccine was evaluated for safety and immunogenicity in healthy infants. While it demonstrated an acceptable safety profile, its immunogenicity was significantly lower than that of the 116E strain (which later became ROTAVAC), leading to the discontinuation of its development after early-phase testing.

Other names
I321 strainI-321 strainI 321 strainrotavirus vaccine candidate I321

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