Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India

Human Vaccines and Immunotherapeutics

Volumn 10, Issue 1, 2014, Pages 2796-2801

  Ashwath Narayana, Doddabele Hanumanthaiah ^a   Madhusudana, Shampur Narayana ^b   Sampath, Gadey ^c   Tripathy, Radhe Madhab ^d   Sudarshan, Mysore Kalappa ^a   Gangaboraiah, ^a   Ravish, Haradanahalli Shankaraiah ^a   Satapathy, Durga Madhab ^d,f   Gowda, Giriyanna ^a   Holla, Ramesh ^a,g   Ashwin, Belludi Yajman ^b   Padhi, Asutosh ^d,h   Manjula, Shamanna ^e   Patel, Pradip Maganlal ^e  

^a KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES   (India)

^b NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES   (India)

^c Institute of Preventive Medicine   (India)

^d MKCG MEDICAL COLLEGE   (India)

^e ZYDUS RESEARCH CENTRE   (India)

^f SCB MEDICAL COLLEGE   (India)

^g KASTURBA MEDICAL COLLEGE   (India)

^h Government Degree College   (India)

Author keywords

Clinical trials; PCEC vaccine; Pitman Moore strain; Post exposure prophylaxis; Rabies; Rabies vaccines

Indexed keywords

EQUIRAB; NEUTRALIZING ANTIBODY; RABIES IMMUNOGLOBULIN; RABIES VACCINE; UNCLASSIFIED DRUG; VAXIRAB N; VIRUS ANTIBODY;

ADULT; ANTIBODY TITER; ARTICLE; BITE; CONCENTRATION RESPONSE; DISEASE SEVERITY; DIZZINESS; DRUG ERUPTION; DRUG EXPOSURE; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; FACE EDEMA; FEMALE; GEOMETRIC MEAN CONCENTRATION; HUMAN; IMMUNOGENICITY; INDIA; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PITMAN MOORE VIRUS STRAIN; POST EXPOSURE PROPHYLAXIS; RABIES; RABIES VIRUS; SIMULATION; SWELLING; VACCINE PRODUCTION; VIRUS STRAIN; VOLUNTEER; YOUNG ADULT;

EID: 84896725309     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.26456     Document Type: Article

References (19)

1. WHO. Rabies vaccines: WHO Position Paper. Wkly Epidemiol Rec 2010; 85:309-20
2. Sudarshan MK, Madhusudana SN, Mahendra BJ, Rao NSN, Ashwath Narayana DH, Abdul Rahman S, Meslin F-, Lobo D, Ravikumar K, Gangaboraiah. Assessing the burden of human rabies in India: results of a national multi-center epidemiological survey. Int J Infect Dis 2007; 11:29-35; PMID:16678463; http://dx.doi.org/10.1016/j.ijid.2005.10.007
3. Sudarshan MK, Mahendra BJ, Madhusudana SN, Ashwoath Narayana DH, Rahman A, Rao NS, X-Meslin F, Lobo D, Ravikumar K, Gangaboraiah. An epidemiological study of animal bites in India: results of a WHO sponsored national multi-centric rabies survey. J Commun Dis 2006; 38:32-9; PMID:17370688
4. WHO expert consultation on rabies. First report. WHO Technical Report series 931, Geneva 2005; 3-4.
5. Wiktor TJ, Koprowski H. Successful immunization of primates with rabies vaccine prepared in human diploid cell strain WI-38. Proc Soc Exp Biol Med 1965; 118:1069-73; PMID:14280692; http://dx.doi.org/10.3181/00379727-118-30048
6. Barth R, Gruschkau H, Bijok U, Hilfenhaus J, Hinz J, Milcke L, Moser H, Jaeger O, Ronneberger H, Weinmann E. A new inactivated tissue culture rabies vaccine for use in man. Evaluation of PCEC-vaccine by laboratory tests. J Biol Stand 1984; 12:29-46; PMID:6199357; http://dx.doi.org/10.1016/S0092-1157(84) 80019-0
7. Wasi C, Chaiprasithikul P, Chavanich L, Puthavathana P, Thongcharoen P, Trishanananda M. Purified chick embryo cell rabies vaccine. Lancet 1986; 1:40; PMID:2867280; http://dx.doi.org/10.1016/S0140-6736(86)91918-5
8. Sehgal S, Bhattacharya D, Bhardwaj M. Ten year longitudinal study of efficacy and safety of purified chick embryo cell vaccine for pre- and post-exposure prophylaxis of rabies in Indian population. J Commun Dis 1995; 27:36-43; PMID:7636151
9. Benjavongkulchai M, Kositprapa C, Limsuwun K, Khawplod P, Thipkong P, Chomchey P, Yountong C, Naraporn N, Ayuthya AB, Raksakate S, et al. An immunogenicity and efficacy study of purified chick embryo cell culture rabies vaccine manufactured in Japan. Vaccine 1997; 15:1816-9; PMID:9413087; http://dx.doi.org/10.1016/S0264-410X(97)00143-6
10. Sudarshan MK, Bharadwaj S, Mehta JM, Parasuramalu BG, Mahendra BJ. Gangaboraiah. Clinical evaluation of safety and efficacy of PCEC rabies vaccine (Kaketsuken) in post exposure treatment. Indian J Matern Child Health 1996; 7:49-52
11. Suntharasamai P, Chanthavanich P, Warrell MJ, Looareesuwan S, Karbwang J, Supanaranond W, Phillips RE, Jansawan W, Xueref C, Pouradier-Duteil X, et al. Purified Vero cell rabies vaccine and human diploid cell strain vaccine: comparison of neutralizing antibody responses to post-exposure regimens. J Hyg (Lond) 1986; 96: 483-9; PMID:3734433; http://dx.doi.org/10.1017/ S0022172400066286
12. Ajjan N, Pilet C. Comparative study of the safety and protective value, in pre-exposure use, of rabies vaccine cultivated on human diploid cells (HDCV) and of the new vaccine grown on Vero cells. Vaccine 1989; 7:125-8; PMID:2665351; http://dx.doi.org/10.1016/0264-410X(89)90050-9
13. Sampath G, Madhusudana SN, Sudarshan MK, Ashwathnarayana DH, Mahendra BJ, Ullas TP, Mohan K, Madhusudhan SK, Ravish HS. Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine. Vaccine 2010; 28:4086-90; PMID:20403351; http://dx.doi.org/10.1016/j.vaccine. 2010.03.064
14. http://www.faqs.org/patents/app/20100189746#b; accessed on 27.1.2013, 22:00 hrs.
15. Plotkin SA, Koprowski H, Rupprecht CE. Rabies vaccines. In: Plotkin SA, Orensterin WA, Offit PA, eds. Vaccines, 5th edition, Saunders Elsevier, 2008, 687-714.
16. Barth R, Franke V, Müller H, Weinmann E. Purified chick-embryo-cell (PCEC) rabies vaccine: its potency performance in different test systems and in humans. Vaccine 1990; 8:41-8; PMID:2316283; http://dx.doi.org/10.1016/0264- 410X(90)90176-M
17. Moore SM, Ricke TA, Davis RD, Briggs DJ. The influence of homologous vs. heterologous challenge virus strains on the serological test results of rabies virus neutralizing assays. Biologicals 2005; 33:269-76; PMID:16168666; http://dx.doi.org/10.1016/j.biologicals.2005.06.005
18. Finke S, Karger A, Freuling C, Müller T. Assessment of inactivated human rabies vaccines: biochemical characterization and genetic identification of virus strains. Vaccine 2012; 30:3603-9; PMID:22469862; http://dx.doi.org/10. 1016/j.vaccine.2012.03.047
19. Smith JS, Yager PA, Baer GM. A rapid fluorescent focus inhibition test (RFFIT) for determining rabies virus-neutralizing antibody. In: Meslin FX, Kaplan MM, Koprowski H, editors. Laboratory techniques in rabies. 4th ed. World Health Organization 1996; 181-91.