Ravish H S1, Akash Khobragade2, Durga Satapathy3, Monica Gupta4, Surendra Kumar5, Vinay Bhomia6, Ramasubramanian V7, Maharshi Desai8, Ashok Dilipkumar Agrawal9. 1. Department of Community Medicine, Kempegowda Institute of Medical Science, Bengaluru, India. 2. Department of Pharmacology, J J Hospital Byculla, Mumbai, India. 3. Department of Community Medicine, VSS Institute of Medical Science and Research, Sambalpur, India. 4. Consultant Physician, Samvedna Hospital, Varanasi, India. 5. Department of Community Medicine, S P Medical College and A.G Hospitals, Bikaner, India. 6. Consultant Physician, Sanjivani Superspeciality Hospital Pvt. Ltd, Ahmedabad, India. 7. Senior Consultant, Infectious Diseases and Tropical Medicine, Apollo Hospital, Chennai, India. 8. Senior Consultant, Infectious Diseases, Apollo Hospitals International Ltd, Gandhinagar, India. 9. Medical Affairs, Cadila Pharmaceuticals Ltd, Ahmedabad, India.
Abstract
BACKGROUND: Rabies vaccines are lifesaving in human post animal exposure. However, the compliance to the complete course of vaccine is found to be only 60%. Hence, there is a need for safe and immunogenic, shorter course vaccine that can enhance the compliance and effectively prevent the disease. OBJECTIVES: To establish a noninferiority of a novel three-dose recombinant rabies G protein vaccine to be administered as simulated postexposure prophylaxis when compared to five-dose WHO prequalified vaccine for better safety and immunogenicity. METHODS: A multi-centric, open label, assessor blind, center-specific block randomized, parallel design, phase III clinical study was conducted among 800 subjects. The eligible subjects were randomized in 2:1 ratio for recombinant rabies G protein vaccine and the reference vaccine. Subjects in recombinant rabies G protein vaccine arm received three doses of vaccine on days 0, 3, and 7, while subjects in reference vaccine arm received five doses of WHO prequalified vaccine on days 0, 3, 7, 14, and 28. RESULTS: The socio-demographic characteristics of the two arms were comparable. About 9.9% subjects in recombinant rabies G protein vaccine arm and 17.2% subjects in reference arm reported adverse events. The sero-protection on day 14 was found to be 99.24% and 97.72% in recombinant rabies G protein vaccine arm and reference vaccine arm respectively and the difference was statistically nonsignificant. CONCLUSION: The novel three-dose recombinant rabies G protein vaccine administered as simulated postexposure prophylaxis was noninferior to five dose WHO prequalified vaccine in terms of safety and immunogenicity.
BACKGROUND: Rabies vaccines are lifesaving in human post animal exposure. However, the compliance to the complete course of vaccine is found to be only 60%. Hence, there is a need for safe and immunogenic, shorter course vaccine that can enhance the compliance and effectively prevent the disease. OBJECTIVES: To establish a noninferiority of a novel three-dose recombinant rabies G protein vaccine to be administered as simulated postexposure prophylaxis when compared to five-dose WHO prequalified vaccine for better safety and immunogenicity. METHODS: A multi-centric, open label, assessor blind, center-specific block randomized, parallel design, phase III clinical study was conducted among 800 subjects. The eligible subjects were randomized in 2:1 ratio for recombinant rabies G protein vaccine and the reference vaccine. Subjects in recombinant rabies G protein vaccine arm received three doses of vaccine on days 0, 3, and 7, while subjects in reference vaccine arm received five doses of WHO prequalified vaccine on days 0, 3, 7, 14, and 28. RESULTS: The socio-demographic characteristics of the two arms were comparable. About 9.9% subjects in recombinant rabies G protein vaccine arm and 17.2% subjects in reference arm reported adverse events. The sero-protection on day 14 was found to be 99.24% and 97.72% in recombinant rabies G protein vaccine arm and reference vaccine arm respectively and the difference was statistically nonsignificant. CONCLUSION: The novel three-dose recombinant rabies G protein vaccine administered as simulated postexposure prophylaxis was noninferior to five dose WHO prequalified vaccine in terms of safety and immunogenicity.
Entities:
Keywords:
Recombinant rabies G protein vaccine; immunogenicity; noninferiority; safety; simulated postexposure prophylaxis
Authors: Mary J Warrell; Anna Riddell; Ly-Mee Yu; Judith Phipps; Linda Diggle; Hervé Bourhy; Jonathan J Deeks; Anthony R Fooks; Laurent Audry; Sharon M Brookes; François-Xavier Meslin; Richard Moxon; Andrew J Pollard; David A Warrell Journal: PLoS Negl Trop Dis Date: 2008-04-23