title: Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine.
abstract: A chromatographically purified Vero cell rabies vaccine, Indirab manufactured by Bharat Biotech International Limited, Hyderabad, India was subjected to safety and immunogenicity studies by both intramuscular and intradermal routes of administration in parallel with a reference vaccine, Verorab. A Pre-exposure study was undertaken in 239 subjects by intramuscular (IM) route (Study I), Post-exposure study in 188 patients by intramuscular route (Study II) and Simulated post-exposure study in 134 subjects by intradermal (ID) route (Study III). All subjects in these studies were administered with either the test or the reference vaccine as per WHO approved intramuscular and intradermal regimens. The blood samples were collected on days 0, 14 and 35 in case of Study 1, and days 0, 14, 28 and 90 in case of studies II and III. In all studies both vaccine groups had adequate antibody titers (>0.5 IU/mL) on all days tested post-vaccination and there was no significant difference in the titers observed (p>0.05). Some side effects like pain, induration, itching and fever were noted in both vaccine groups in all studies. Both vaccines were well tolerated. Hence it can be concluded that Indirab is as safe and immunogenic as Verorab when administered by both intramuscular and intradermal routes.
authors.affiliation: Institute of Preventive Medicine, Hyderabad, India.
authors.forename: Gadey
authors.initials: G
authors.lastname: Sampath
authors.forename: Shampur Narayan
authors.initials: SN
authors.lastname: Madhusudana
authors.forename: Mysore Kalappa
authors.initials: MK
authors.lastname: Sudarshan
authors.forename: Doddabele Hanumanthaiah
authors.initials: DH
authors.lastname: Ashwathnarayana
authors.forename: Bangalore Jayakrishna
authors.initials: BJ
authors.lastname: Mahendra
authors.forename: Thankappan P
authors.initials: TP
authors.lastname: Ullas
authors.forename: Krishna
authors.initials: K
authors.lastname: Mohan
authors.forename: Santhosh Kumar
authors.initials: SK
authors.lastname: Madhusudhan
authors.forename: Haradanahalli Shankariah
authors.initials: HS
authors.lastname: Ravish
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002522:Chlorocebus aethiops; D002845:Chromatography; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D011818:Rabies / Q000276:immunology / Q000517:prevention & control; D011819:Rabies Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014709:Vero Cells; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines