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A comparative study on the safety and immunogenicity of Purified duck embryo vaccine [corrected] (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCEC, Rabipur) and purifed vero cell rabies vaccine (PVRV, Verorab).
Vaccine. 2009 Dec 10; 28(1):148-51.V

Abstract

Rabies is a fatal but preventable disease. Cell culture vaccines (CCV) and purified duck embryo vaccines (PDEV) are currently recommended by WHO for post-exposure prophylaxis. In India, a PDEV (Vaxirab) is being manufactured and is in use since 2003. In the present study, we have evaluated the safety, immunogenicity and tolerance of this vaccine with two other WHO approved CCVs, viz., purified chick embryo cell vaccine (PCEC, Rabipur) and purified vero cell rabies vaccine (PVRV, Veroroab). This study was an open label, randomized phase IV comparative clinical trial. A total of 152 people bitten by dogs and other animals were recruited from 4 different centres from India. They were randomly assigned to receive one of the vaccines by Essen intramuscular regimen (52 subjects received Vaxirab and 50 each Rabipur and Verorab) and rabies immunoglobulin was also administered in all category III exposures. Their blood samples were collected on day 0 (prior to vaccination), 14, 28, 90 and 180. Side effects if any were monitored. The rabies neutralizing antibody titers in their blood samples were estimated by the rapid fluorescent focus inhibition test (RFFIT). Subjects in all three groups had neutralizing antibody titers by day 14 (>0.5 IU/mL) and geometric mean titers (GMT) observed for different vaccines on all days tested did not vary significantly (p>0.5). Side effects observed were minimal and did not vary significantly among the groups. The results of the present study indicate that PDEV (Vaxirab) is as safe, tolerable and immunogenic as both PCEC (Rabipur) and PVRV (Verorab). Thus this vaccine can be a good alternative to WHO approved CCVs for rabies post-exposure prophylaxis.

Authors+Show Affiliations

Dept. of Community Medicine, Kempegowda Institute of Medical Sciences, Bangalore 560004, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19818720

Citation

Ashwathnarayana, Doddabele Hanumantaiah, et al. "A Comparative Study On the Safety and Immunogenicity of Purified Duck Embryo Vaccine [corrected] (PDEV, Vaxirab) With Purified Chick Embryo Cell Vaccine (PCEC, Rabipur) and Purifed Vero Cell Rabies Vaccine (PVRV, Verorab)." Vaccine, vol. 28, no. 1, 2009, pp. 148-51.
Ashwathnarayana DH, Madhusudana SN, Sampath G, et al. A comparative study on the safety and immunogenicity of Purified duck embryo vaccine [corrected] (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCEC, Rabipur) and purifed vero cell rabies vaccine (PVRV, Verorab). Vaccine. 2009;28(1):148-51.
Ashwathnarayana, D. H., Madhusudana, S. N., Sampath, G., Sathpathy, D. M., Mankeshwar, R., Ravish, H. H., Ullas, P. T., Behra, T. R., Sudarshan, M. K., Gangaboraiah, ., & Shamanna, M. (2009). A comparative study on the safety and immunogenicity of Purified duck embryo vaccine [corrected] (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCEC, Rabipur) and purifed vero cell rabies vaccine (PVRV, Verorab). Vaccine, 28(1), 148-51. https://doi.org/10.1016/j.vaccine.2009.09.090
Ashwathnarayana DH, et al. A Comparative Study On the Safety and Immunogenicity of Purified Duck Embryo Vaccine [corrected] (PDEV, Vaxirab) With Purified Chick Embryo Cell Vaccine (PCEC, Rabipur) and Purifed Vero Cell Rabies Vaccine (PVRV, Verorab). Vaccine. 2009 Dec 10;28(1):148-51. PubMed PMID: 19818720.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative study on the safety and immunogenicity of Purified duck embryo vaccine [corrected] (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCEC, Rabipur) and purifed vero cell rabies vaccine (PVRV, Verorab). AU - Ashwathnarayana,Doddabele Hanumantaiah, AU - Madhusudana,Shampur Narayana, AU - Sampath,Gadey, AU - Sathpathy,Durga Madhab, AU - Mankeshwar,Ranjit, AU - Ravish,Haradana Halli Shankariah, AU - Ullas,Padinjaremattathil Thankappan, AU - Behra,Tapas Ranjan, AU - Sudarshan,Mysore Kalappa, AU - Gangaboraiah,, AU - Shamanna,Manjula, Y1 - 2009/10/08/ PY - 2009/04/02/received PY - 2009/07/13/revised PY - 2009/09/23/accepted PY - 2009/10/13/entrez PY - 2009/10/13/pubmed PY - 2010/1/29/medline SP - 148 EP - 51 JF - Vaccine JO - Vaccine VL - 28 IS - 1 N2 - Rabies is a fatal but preventable disease. Cell culture vaccines (CCV) and purified duck embryo vaccines (PDEV) are currently recommended by WHO for post-exposure prophylaxis. In India, a PDEV (Vaxirab) is being manufactured and is in use since 2003. In the present study, we have evaluated the safety, immunogenicity and tolerance of this vaccine with two other WHO approved CCVs, viz., purified chick embryo cell vaccine (PCEC, Rabipur) and purified vero cell rabies vaccine (PVRV, Veroroab). This study was an open label, randomized phase IV comparative clinical trial. A total of 152 people bitten by dogs and other animals were recruited from 4 different centres from India. They were randomly assigned to receive one of the vaccines by Essen intramuscular regimen (52 subjects received Vaxirab and 50 each Rabipur and Verorab) and rabies immunoglobulin was also administered in all category III exposures. Their blood samples were collected on day 0 (prior to vaccination), 14, 28, 90 and 180. Side effects if any were monitored. The rabies neutralizing antibody titers in their blood samples were estimated by the rapid fluorescent focus inhibition test (RFFIT). Subjects in all three groups had neutralizing antibody titers by day 14 (>0.5 IU/mL) and geometric mean titers (GMT) observed for different vaccines on all days tested did not vary significantly (p>0.5). Side effects observed were minimal and did not vary significantly among the groups. The results of the present study indicate that PDEV (Vaxirab) is as safe, tolerable and immunogenic as both PCEC (Rabipur) and PVRV (Verorab). Thus this vaccine can be a good alternative to WHO approved CCVs for rabies post-exposure prophylaxis. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/19818720/A_comparative_study_on_the_safety_and_immunogenicity_of_Purified_duck_embryo_vaccine_[corrected]__PDEV_Vaxirab__with_purified_chick_embryo_cell_vaccine__PCEC_Rabipur__and_purifed_vero_cell_rabies_vaccine__PVRV_Verorab__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)01437-6 DB - PRIME DP - Unbound Medicine ER -