Immunogenicity and safety study of Indirab: A Vero cell based chromatographically purified human rabies vaccine |
| |
Authors: | Gadey Sampath Shampur Narayan Madhusudana Mysore Kalappa Sudarshan Doddabele Hanumanthaiah Ashwathnarayana Bangalore Jayakrishna Mahendra Thankappan P. Ullas Krishna Mohan Santhosh Kumar Madhusudhan Haradanahalli Shankariah Ravish |
| |
Affiliation: | 1. Institute of Preventive Medicine, Hyderabad, India;2. Dept. of Neurovirology, National Institute of Mental Health & Neurosciences (NIMHANS), Hosur Road, Bangalore, India;3. Dept. of Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, India;4. Dept. of Community Medicine, Mandya Institute of Medical Sciences, Mandya, India;5. Bharat Biotech International Ltd., Hyderabad, India |
| |
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. |
| |
Keywords: | Rabies Rabies vaccines Purified Vero cell rabies vaccine Chromatographically purified Vero cell rabies vaccine |
本文献已被 ScienceDirect 等数据库收录! |
|