title: Bovine rotavirus pentavalent vaccine development in India.
abstract: A bovine rotavirus pentavalent vaccine (BRV-PV) containing rotavirus human-bovine (UK) reassortant strains of serotype G1, G2, G3, G4 and G9 has been developed by the Serum Institute of India Ltd, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), USA. The vaccine underwent animal toxicity studies and Phase I and II studies in adults, toddlers and infants. It has been found safe and immunogenic and will undergo a large Phase III study to assess efficacy against severe rotavirus gastroenteritis.
authors.affiliation: Serum Institute of India Ltd., Pune, India.
authors.forename: Jagdish K
authors.initials: JK
authors.lastname: Zade
authors.affiliation: Serum Institute of India Ltd., Pune, India. Electronic address: drpsk@seruminstitute.com.
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.affiliation: Serum Institute of India Ltd., Pune, India.
authors.forename: Sajjad A
authors.initials: SA
authors.lastname: Desai
authors.affiliation: Serum Institute of India Ltd., Pune, India.
authors.forename: Rajendra N
authors.initials: RN
authors.lastname: Sabale
authors.affiliation: Serum Institute of India Ltd., Pune, India.
authors.forename: Sameer P
authors.initials: SP
authors.lastname: Naik
authors.affiliation: Serum Institute of India Ltd., Pune, India.
authors.forename: Rajeev M
authors.initials: RM
authors.lastname: Dhere
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002417:Cattle; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D005759:Gastroenteritis / Q000517:prevention & control / Q000821:virology; D007194:India; D011817:Rabbits; D016032:Randomized Controlled Trials as Topic; D017208:Rats, Wistar; D016865:Reassortant Viruses; D012401:Rotavirus; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000276:immunology*; D018675:Toxicity Tests; D014613:Vaccines, Attenuated / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: Bovine rotavirus pentavalent rotavirus vaccine (BRV-PV); Clinical trials; Development; Serum Institute of India Ltd.