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Review Article
Clinical Studies of Rabies Vaccines in India: A Review and Pooled Analysis of Immunogenicity and Safety Outcomes
Shaitan Singh1
Nidhi Tyagi2
Nitin Kumar3
1 2 3 Department of Pharmacology, Saraswathi College of Pharmacy, Anwarpur, Uttar Pradesh, India.
Published Online: May-June 2026
Pages: 55-65
Cite this article
↗ https://www.doi.org/10.59256/ijrtmr.20260603007References
[1]. World Health Organization. WHO Expert Consultation on Rabies: Third Report. WHO Technical Report Series No. 1012. Geneva:
WHO; 2018.
[2]. Hampson K, Coudeville L, Lembo T, Sambo M, Kieffer A, Attlan M, et al. Estimating the global burden of endemic canine rabies. PLoS
Negl Trop Dis. 2015;9(4):e0003709.
[3]. Menezes R. Rabies in India. CMAJ. 2008;178(5):564–566.
[4]. Sudarshan MK, Mahendra BJ, Madhusudana SN, Ashwath Narayana DH, Rahman A, Rao NS, et al. An epidemiological study of animal
bites in India: results of a WHO sponsored national multi-centric rabies survey. J Commun Dis. 2006;38(1):32–39.
[5]. World Health Organization. Rabies vaccines: WHO position paper – April 2018. Wkly Epidemiol Rec. 2018;93(16):201–220.
[6]. National Centre for Disease Control, India. National Rabies Control Programme: guidelines for prevention and control of rabies in India.
New Delhi: Ministry of Health and Family Welfare; 2019.
[7]. Knobel DL, Cleaveland S, Coleman PG, Fèvre EM, Meltzer MI, Miranda MEG, et al. Re-evaluating the burden of rabies in Africa and
Asia. Bull World Health Organ. 2005;83(5):360–368.
[8]. Madhusudana SN, Tripathi KK, Bhatt DL, et al. Evaluation of post-exposure prophylaxis using intradermal rabies vaccination regimens
in subjects bitten by rabid animals in India. Int J Infect Dis. 2001;5(4):189–193.
[9]. Sudarshan MK, Madhusudana SN, Mahendra BJ, et al. Safety and immunogenicity of a new purified chick embryo cell rabies vaccine
(Rabipur) in children. Hum Vaccin. 2005;1(4):152–155.
[10]. Ashwathnarayana DH, Madhusudana SN, Sampath G, Sathpathy DM, Mankeshwar R, Ravish HS, et al. A comparative study on the
safety and immunogenicity of purified duck embryo vaccine (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCECV,
Rabipur) and purified Vero cell rabies vaccine (PVRV, Verorab). Vaccine. 2010;28(13):2574–2578.
[11]. Sampath G, Bhatt M, Reddy P, et al. Safety and immunogenicity of Indirab, an indigenous Vero cell rabies vaccine in post-exposure
prophylaxis. Vaccine. 2010;28(47):7525–7529.
[12]. Sudarshan MK, Ashwath Narayana DH, Madhusudana SN, Holla R, et al. Evaluation of a one week intradermal regimen for rabies post-
exposure prophylaxis: results of a randomized, open label, active-controlled trial in healthy adult volunteers in India. Hum Vaccin
Immunother. 2012;8(8):1077–1081.
[13]. Narayana DHA, Ravish HS, Sudarshan MK, et al. Safety and immunogenicity of a next-generation purified Vero cell rabies vaccine
(Vaxirab-N) in healthy Indian adults: results from multiple ICH-GCP compliant clinical studies. Hum Vaccin Immunother.
2014;10(9):2461–2467.
[14]. Narayana DHA, Madhusudana SN, Ravish HS, et al. Safety and immunogenicity of purified chick embryo cell vaccine versus purified
Vero cell rabies vaccine using the intradermal route: a Phase III non-inferiority randomized controlled trial. Vaccine. 2015;33(30):3551–
3556.
[15]. Bose A, Tripathi SC, Aggarwal N, et al. Non-inferiority immunogenicity and safety of an indigenous purified chick embryo cell rabies
vaccine (Rabivax-S) versus standard reference vaccine: a randomized controlled trial. Hum Vaccin Immunother. 2016;12(12):3068–
3073.
[16]. Haradanahalli RS, Abhilash KPP, Varghese GM, et al. Effectiveness and immunogenicity of 4-dose intramuscular rabies post-exposure
prophylaxis regimen in comparison to 5-dose Essen regimen: an Indian comparative study. Vaccine. 2021;39(26):3529–3534.
[17]. Singh R, Arora NK, Vashisht P, et al. Non-inferiority of a single-visit intradermal pre-exposure prophylaxis schedule for rabies compared
to standard 3-visit regimen: a Phase III randomized controlled trial. Lancet Infect Dis. 2025 [forthcoming].
[18]. Rupprecht CE, Briggs D, Brown CM, et al. Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human
rabies: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2010;59(RR-2):1–9.
[19]. National Centre for Disease Control, India. National Rabies Control Programme operational guidelines. New Delhi: Ministry of Health
and Family Welfare, Government of India; 2019.[20]. Sudarshan MK, Madhusudana SN, Mahendra BJ, et al. Assessing the burden of human rabies in India: results of a national multi-center
epidemiological survey. Int J Infect Dis. 2007;11(1):29–35.
[21]. Shanbag P, Shah N, Kulkarni M, Juvekar M, Madhusudana SN, Vakil HB, et al. Protecting Indian schoolchildren against rabies: pre-
exposure vaccination with purified chick embryo cell vaccine (PCECV) or purified Vero cell rabies vaccine (PVRV). Hum Vaccin.
2008;4(5):365–369.
[22]. Zero by 30: The Global Strategic Plan to End Human Deaths from Dog-Mediated Rabies by 2030. Geneva: World Health Organization,
World Organisation for Animal Health, Food and Agriculture Organization, Global Alliance for Rabies Control; 2018.
[23]. O'Brien KL, Nolan T; SAGE Working Group on Rabies. The WHO position on rabies immunization – 2018 updates. Vaccine.
2019;37(Suppl 1):A85–A87.
WHO; 2018.
[2]. Hampson K, Coudeville L, Lembo T, Sambo M, Kieffer A, Attlan M, et al. Estimating the global burden of endemic canine rabies. PLoS
Negl Trop Dis. 2015;9(4):e0003709.
[3]. Menezes R. Rabies in India. CMAJ. 2008;178(5):564–566.
[4]. Sudarshan MK, Mahendra BJ, Madhusudana SN, Ashwath Narayana DH, Rahman A, Rao NS, et al. An epidemiological study of animal
bites in India: results of a WHO sponsored national multi-centric rabies survey. J Commun Dis. 2006;38(1):32–39.
[5]. World Health Organization. Rabies vaccines: WHO position paper – April 2018. Wkly Epidemiol Rec. 2018;93(16):201–220.
[6]. National Centre for Disease Control, India. National Rabies Control Programme: guidelines for prevention and control of rabies in India.
New Delhi: Ministry of Health and Family Welfare; 2019.
[7]. Knobel DL, Cleaveland S, Coleman PG, Fèvre EM, Meltzer MI, Miranda MEG, et al. Re-evaluating the burden of rabies in Africa and
Asia. Bull World Health Organ. 2005;83(5):360–368.
[8]. Madhusudana SN, Tripathi KK, Bhatt DL, et al. Evaluation of post-exposure prophylaxis using intradermal rabies vaccination regimens
in subjects bitten by rabid animals in India. Int J Infect Dis. 2001;5(4):189–193.
[9]. Sudarshan MK, Madhusudana SN, Mahendra BJ, et al. Safety and immunogenicity of a new purified chick embryo cell rabies vaccine
(Rabipur) in children. Hum Vaccin. 2005;1(4):152–155.
[10]. Ashwathnarayana DH, Madhusudana SN, Sampath G, Sathpathy DM, Mankeshwar R, Ravish HS, et al. A comparative study on the
safety and immunogenicity of purified duck embryo vaccine (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCECV,
Rabipur) and purified Vero cell rabies vaccine (PVRV, Verorab). Vaccine. 2010;28(13):2574–2578.
[11]. Sampath G, Bhatt M, Reddy P, et al. Safety and immunogenicity of Indirab, an indigenous Vero cell rabies vaccine in post-exposure
prophylaxis. Vaccine. 2010;28(47):7525–7529.
[12]. Sudarshan MK, Ashwath Narayana DH, Madhusudana SN, Holla R, et al. Evaluation of a one week intradermal regimen for rabies post-
exposure prophylaxis: results of a randomized, open label, active-controlled trial in healthy adult volunteers in India. Hum Vaccin
Immunother. 2012;8(8):1077–1081.
[13]. Narayana DHA, Ravish HS, Sudarshan MK, et al. Safety and immunogenicity of a next-generation purified Vero cell rabies vaccine
(Vaxirab-N) in healthy Indian adults: results from multiple ICH-GCP compliant clinical studies. Hum Vaccin Immunother.
2014;10(9):2461–2467.
[14]. Narayana DHA, Madhusudana SN, Ravish HS, et al. Safety and immunogenicity of purified chick embryo cell vaccine versus purified
Vero cell rabies vaccine using the intradermal route: a Phase III non-inferiority randomized controlled trial. Vaccine. 2015;33(30):3551–
3556.
[15]. Bose A, Tripathi SC, Aggarwal N, et al. Non-inferiority immunogenicity and safety of an indigenous purified chick embryo cell rabies
vaccine (Rabivax-S) versus standard reference vaccine: a randomized controlled trial. Hum Vaccin Immunother. 2016;12(12):3068–
3073.
[16]. Haradanahalli RS, Abhilash KPP, Varghese GM, et al. Effectiveness and immunogenicity of 4-dose intramuscular rabies post-exposure
prophylaxis regimen in comparison to 5-dose Essen regimen: an Indian comparative study. Vaccine. 2021;39(26):3529–3534.
[17]. Singh R, Arora NK, Vashisht P, et al. Non-inferiority of a single-visit intradermal pre-exposure prophylaxis schedule for rabies compared
to standard 3-visit regimen: a Phase III randomized controlled trial. Lancet Infect Dis. 2025 [forthcoming].
[18]. Rupprecht CE, Briggs D, Brown CM, et al. Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human
rabies: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2010;59(RR-2):1–9.
[19]. National Centre for Disease Control, India. National Rabies Control Programme operational guidelines. New Delhi: Ministry of Health
and Family Welfare, Government of India; 2019.[20]. Sudarshan MK, Madhusudana SN, Mahendra BJ, et al. Assessing the burden of human rabies in India: results of a national multi-center
epidemiological survey. Int J Infect Dis. 2007;11(1):29–35.
[21]. Shanbag P, Shah N, Kulkarni M, Juvekar M, Madhusudana SN, Vakil HB, et al. Protecting Indian schoolchildren against rabies: pre-
exposure vaccination with purified chick embryo cell vaccine (PCECV) or purified Vero cell rabies vaccine (PVRV). Hum Vaccin.
2008;4(5):365–369.
[22]. Zero by 30: The Global Strategic Plan to End Human Deaths from Dog-Mediated Rabies by 2030. Geneva: World Health Organization,
World Organisation for Animal Health, Food and Agriculture Organization, Global Alliance for Rabies Control; 2018.
[23]. O'Brien KL, Nolan T; SAGE Working Group on Rabies. The WHO position on rabies immunization – 2018 updates. Vaccine.
2019;37(Suppl 1):A85–A87.
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