A Post Marketing Surveillance Study To Evaluate The Safety Of Abhayrab Vaccine, A Purified Vero Cell Rabies Vaccine Manufactured Byhuman Biologicals Institute, When Administered By Intradermalroute In Category Iianimal Exposure Subjects In India.
Journal Title: IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) - Year 2018, Vol 17, Issue 4
Abstract
Background:Rabies is a viral disease which is almost always fatal. It is a neglected zoonotic disease which still causes significant mortality, mostly in the developing and third world countries. The mainstay in prevention of rabies is timely vaccination with a safe and potent anti-rabies vaccine. Abhayrab Vaccine, a purified Vero cell rabies vaccine (PVRV) manufactured by Human Biologicals Institute, has proved its safety and efficacy since its launch. The objective of this post marketing surveillance study is to further evaluate the safety of the Abhayrab vaccine when administered by Intradermal route in Category II animal exposure subjects in India. Methods: In an open label single arm single centric study, a total of 101 subjects meeting the eligibility criteria were enrolled in the study. Abhayrab Vaccine was reconstituted to 1 ml and two doses of 0.1ml wereadministered intradermally, one on each deltoid region on days 0, 3, 7 and 28 as per Updated Thai Red Crossregimen. The safety data was collected and evaluated throughout the study period from the time of first dose of vaccination till 7 days of the last dose of vaccination. Results: A total of 88 mild or moderate local and systemic adverse events were reported in the study. No Serious adverse event was recorded during the study period. Overall it was concluded that Abhayrab vaccine issafe when administered by Intradermal route in Category II animal exposure subjects in India.
Authors and Affiliations
Dr. G. Sampath, Dr. S. Sai Krishna. , M. Satish, G. Sandhya
Keywords
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- EP ID EP370596
- DOI 10.9790/0853-1704063640
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