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

作者：Mahendra Bangalore Jayakrishnappa; Madhusudana Shampur Narayan^*; Ashwathnarayana Doddabele Hanumanthaiah; Sampath Gadey; datta Soma Subhra; Sudarshan Mysore Kalappa; Venkatesh Gonibeedu Manjunatah; Muhamuda Kader; Bilagumba Gangaboraiah; Shamanna Manjula

来源：Vaccine, 2007, 25(50): 8405-8409.

DOI：10.1016/j.vaccine.2007.10.002

• rabies
• rabies vaccines
• rabies prophylaxis
• purified duck embryo vaccine

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.

• 出版日期2007-12-5
• 单位河北医科大学