title: 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.
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.affiliation: Department of Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), K.R. road, Bangalore 560004, India.
authors.forename: Bangalore Jayakrishnappa
authors.initials: BJ
authors.lastname: Mahendra
authors.forename: Shampur Narayan
authors.initials: SN
authors.lastname: Madhusudana
authors.forename: Doddabele Hanumanthaiah
authors.initials: DH
authors.lastname: Ashwathnarayana
authors.forename: Gadey
authors.initials: G
authors.lastname: Sampath
authors.forename: Soma Subhra
authors.initials: SS
authors.lastname: datta
authors.forename: Mysore Kalappa
authors.initials: MK
authors.lastname: Sudarshan
authors.forename: Gonibeedu Manjunatah
authors.initials: GM
authors.lastname: Venkatesh
authors.forename: Kader
authors.initials: K
authors.lastname: Muhamuda
authors.forename: Gangaboraiah
authors.initials: G
authors.lastname: Bilagumba
authors.forename: Manjula
authors.initials: M
authors.lastname: Shamanna
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002460:Cell Line; D018890:Chemoprevention; D006224:Cricetinae; D004372:Ducks / Q000196:embryology; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D011820:Rabies virus / Q000276:immunology; D013557:Switzerland
chemical_list: D000914:Antibodies, Viral; D011819:Rabies Vaccines