title: 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).
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.affiliation: Dept. of Community Medicine, Kempegowda Institute of Medical Sciences, Bangalore 560004, India.
authors.forename: Doddabele Hanumantaiah
authors.initials: DH
authors.lastname: Ashwathnarayana
authors.forename: Shampur Narayana
authors.initials: SN
authors.lastname: Madhusudana
authors.forename: Gadey
authors.initials: G
authors.lastname: Sampath
authors.forename: Durga Madhab
authors.initials: DM
authors.lastname: Sathpathy
authors.forename: Ranjit
authors.initials: R
authors.lastname: Mankeshwar
authors.forename: Haradana Halli Shankariah
authors.initials: HH
authors.lastname: Ravish
authors.forename: Padinjaremattathil Thankappan
authors.initials: PT
authors.lastname: Ullas
authors.forename: Tapas Ranjan
authors.initials: TR
authors.lastname: Behra
authors.forename: Mysore Kalappa
authors.initials: MK
authors.lastname: Sudarshan
authors.lastname: Gangaboraiah
authors.forename: Manjula
authors.initials: M
authors.lastname: Shamanna
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002642:Chick Embryo; D002648:Child; D002675:Child, Preschool; D002522:Chlorocebus aethiops; D004285:Dogs; D004372:Ducks; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D056990:Post-Exposure Prophylaxis; D011818:Rabies / Q000276:immunology / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000009:adverse effects / Q000276:immunology*; D014709:Vero Cells; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines