title: Development of a new purified vero cell rabies vaccine (Rabivax-S) at the serum institute of India Pvt Ltd.
abstract: Rabies is a 100% fatal disease with significant disease burden in Asia and Africa but preventable with vaccines and immunoglobulins. There are very few WHO prequalified cell culture derived rabies vaccines available globally for use in humans. We have developed a new purified vero cell rabies vaccine (Rabivax-S) to meet this demand. Areas covered: In this review, we have described the detailed manufacturing process of Rabivax-S and summary of preclinical and clinical development based on the data generated in-house. Expert commentary: Rabivax-S has been developed on Vero ATCC CCL81 cells using Pitman Moore (PM3218) strain. Following all the GMP requirements the vaccine was tested in GLP toxicology studies. Further it underwent clinical trials in preexposure and postexposure settings and was found safe and immunogenic.
authors.affiliation: a Serum Institute of India Pvt. Ltd ., Pune , India.
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.affiliation: a Serum Institute of India Pvt. Ltd ., Pune , India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Sahai
authors.affiliation: a Serum Institute of India Pvt. Ltd ., Pune , India.
authors.forename: Bhagwat
authors.initials: B
authors.lastname: Gunale
authors.affiliation: a Serum Institute of India Pvt. Ltd ., Pune , India.
authors.forename: Rajeev M
authors.initials: RM
authors.lastname: Dhere
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002522:Chlorocebus aethiops; D002986:Clinical Trials as Topic; D004306:Dose-Response Relationship, Immunologic; D006801:Humans; D000071497:Immunogenicity, Vaccine; D011786:Quality Control; D011818:Rabies / Q000276:immunology / Q000517:prevention & control; D011819:Rabies Vaccines / Q000737:chemistry* / Q000276:immunology*; D011820:Rabies virus / Q000276:immunology; D016032:Randomized Controlled Trials as Topic; D014709:Vero Cells / Q000166:cytology*; D014764:Viral Proteins / Q000235:genetics
chemical_list: D000914:Antibodies, Viral; D011819:Rabies Vaccines; D014764:Viral Proteins; C532964:rabivax
keywords: Rabivax-S; immunogenicity; purified vero cell rabies vaccine; rabies; safety