Safety of Rabies vaccine Human I.P. (Purified Vero Cell Rabies Vaccine) - Abhayrab vaccine, manufactured byHuman Biologicals Institute, when administered in Category IIanimal exposure subjects by Intramuscular or Intradermalroute.
Journal Title: IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) - Year 2017, Vol 17, Issue 2
Abstract
Background: Rabies is an enzootic and epizootic disease of worldwide importance. Globally each year, more than 15 million people require post exposure treatment.Rabies is a vaccine-preventable viral disease. Prevention of Rabiesdepends highly on availability and affordability of potent anti-rabies vaccine.Abhayrab vaccine (manufactured by Human Biologicals Institute) is a freeze dried, purified inactivated rabies vaccine containing inactivated Rabies Virus (L. Pasteur 2061/ Vero Strain propagated in Vero Cells) and has been found to be safe and efficacious for prophylaxis against human rabies since its launch.This study is a post marketing surveillance study carried out with the objective of assessing the safety of Abhayrab vaccine (reconstituted to 1 ml) when administered in Category II animal exposure subjects by Intramuscular or Intradermal route. Methods: In an open label, two arm, single centric study, a total of 120 eligible subjects meeting the inclusion and exclusion criteria were enrolled into the study.Of them, 60 Subjects were enrolled in Arm A, wherevaccine was administeredby intramuscular route asper Essenregimen(One dose of 1ml administered in the deltoid region in adults and in the anterolateral aspect of thigh in children on days 0,3,7, 14 and 28) and 60 Subjects were enrolled inArm B, where vaccine was administered by intradermal route as per Updated Thai Red crossregimen (Two doses of 0.1ml administered one on each deltoid region on days 0,3, 7 and 28). The safety data was evaluatedthroughout the study period from first dose of vaccination totill 7 days of last dose of vaccination in both the Arms. Results:A total of 87 mild or moderate local and systemic adverse events were reported (including 33 in Arm A and 54 in Arm B) in the study.No serious adverse event was reported during the study period. Overall,Abhayrab vaccine when reconstituted to 1 ml wasfound to be safe when administered by intramuscular or intradermal route.
Authors and Affiliations
Dr. G. Sampath, M. Satish, G. Sandhya2, Dr. S. Sai Krishna
Keywords
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