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

被引：6

作者：

Mahendra, Bangalore Jayakrishnappa ^{[1
]}

Madhusudana, Shampur Narayan ^{[2
]}

Ashwathnarayana, Doddabele Hanumanthaiah ^{[1
]}

Sampath, Gadey ^{[3
]}

datta, Soma Subhra ^{[4
]}

Sudarshan, Mysore Kalappa ^{[1
]}

Venkatesh, Gonibeedu Manjunatah ^{[1
]}

Muhamuda, Kader ^{[2
]}

Bilagumba, Gangaboraiah ^{[1
]}

Shamanna, Manjula ^{[5
]}

机构：

[1] Kempegowda Inst Med Sci, Dept Community Med, Bangalore 560004, Karnataka, India

[2] Natl Inst Mental Hlth & Neurosci, Dept Neurovirol, Bangalore 560029, Karnataka, India

[3] Inst Prevent Med, Hyderabad, Andhra Pradesh, India

[4] Inst Pasteur, Kolkata, India

[5] Zudus Cadila Hlth Care Ltd, Bangalore, Karnataka, India

来源：

VACCINE | 2007年 / 25卷 / 50期

关键词：

rabies; rabies vaccines; rabies prophylaxis; purified duck embryo vaccine;

D O I：

10.1016/j.vaccine.2007.10.002

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. (c) 2007 Elsevier Ltd. All rights reserved.

引用

页码：8405 / 8409

页数：5

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