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A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers.
Vaccine. 2007 Dec 05; 25(50):8405-9.V

Abstract

Purified duck embryo vaccine (PDEV, Vaxirab) for rabies prophylaxis is now indigenously manufactured in India under technology transfer from Berna Biotech who made the original PDEV (Lyssavac). In the present study we have compared the two vaccines in terms of safety, immunogenicity and tolerance. The study was conducted in 220 adult healthy volunteers. It was observed that both vaccines produced neutralizing antibody titers (as determined by rapid fluorescent focus inhibition test, RFFIT) more than 0.5 IU/mL (minimum level for seroconversion) on all days tested but the titers on days 90 and 180 were significantly higher with Lyssavac. The adverse reactions produced were slightly more with Lysssavac but both vaccines were well tolerated. In conclusion, the indigenously produced PDEV (Vaxirab) was found to be equally safe and immunogenic as the original PDEV (Lyssavac) manufactured at Switzerland.

Authors+Show Affiliations

Department of Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), K.R. road, 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 available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

17981377

Citation

Mahendra, Bangalore Jayakrishnappa, et al. "A Comparative Study On the Immunogenicity, Safety and Tolerance of Purified Duck Embryo Vaccine (PDEV) Manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a Randomized Simulated Post-exposure Study in Healthy Volunteers." Vaccine, vol. 25, no. 50, 2007, pp. 8405-9.
Mahendra BJ, Madhusudana SN, Ashwathnarayana DH, et al. A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers. Vaccine. 2007;25(50):8405-9.
Mahendra, B. J., Madhusudana, S. N., Ashwathnarayana, D. H., Sampath, G., datta, S. S., Sudarshan, M. K., Venkatesh, G. M., Muhamuda, K., Bilagumba, G., & Shamanna, M. (2007). A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers. Vaccine, 25(50), 8405-9.
Mahendra BJ, et al. A Comparative Study On the Immunogenicity, Safety and Tolerance of Purified Duck Embryo Vaccine (PDEV) Manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a Randomized Simulated Post-exposure Study in Healthy Volunteers. Vaccine. 2007 Dec 5;25(50):8405-9. PubMed PMID: 17981377.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers. AU - Mahendra,Bangalore Jayakrishnappa, AU - Madhusudana,Shampur Narayan, AU - Ashwathnarayana,Doddabele Hanumanthaiah, AU - Sampath,Gadey, AU - datta,Soma Subhra, AU - Sudarshan,Mysore Kalappa, AU - Venkatesh,Gonibeedu Manjunatah, AU - Muhamuda,Kader, AU - Bilagumba,Gangaboraiah, AU - Shamanna,Manjula, Y1 - 2007/10/22/ PY - 2007/07/24/received PY - 2007/10/03/revised PY - 2007/10/03/accepted PY - 2007/11/6/pubmed PY - 2008/2/27/medline PY - 2007/11/6/entrez SP - 8405 EP - 9 JF - Vaccine JO - Vaccine VL - 25 IS - 50 N2 - Purified duck embryo vaccine (PDEV, Vaxirab) for rabies prophylaxis is now indigenously manufactured in India under technology transfer from Berna Biotech who made the original PDEV (Lyssavac). In the present study we have compared the two vaccines in terms of safety, immunogenicity and tolerance. The study was conducted in 220 adult healthy volunteers. It was observed that both vaccines produced neutralizing antibody titers (as determined by rapid fluorescent focus inhibition test, RFFIT) more than 0.5 IU/mL (minimum level for seroconversion) on all days tested but the titers on days 90 and 180 were significantly higher with Lyssavac. The adverse reactions produced were slightly more with Lysssavac but both vaccines were well tolerated. In conclusion, the indigenously produced PDEV (Vaxirab) was found to be equally safe and immunogenic as the original PDEV (Lyssavac) manufactured at Switzerland. SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/17981377/A_comparative_study_on_the_immunogenicity_safety_and_tolerance_of_purified_duck_embryo_vaccine__PDEV__manufactured_in_India__Vaxirab__and_Switzerland__Lyssavac_N_:_a_randomized_simulated_post_exposure_study_in_healthy_volunteers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(07)01141-3 DB - PRIME DP - Unbound Medicine ER -