A comparative study on the safety and immunogenicity of purified duck embryo cell vaccine (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCEC, Rabipur) and purifed vero cell rabies vaccine (PVRV, Verorab)

作者: Doddabele Hanumantaiah Ashwathnarayana , Shampur Narayana Madhusudana , Gadey Sampath , Durga Madhab Sathpathy , Ranjit Mankeshwar

DOI: 10.1016/J.VACCINE.2009.09.090

关键词:

摘要: Rabies is a fatal but preventable disease. Cell culture vaccines (CCV) and purified duck embryo (PDEV) are currently recommended by WHO for post-exposure prophylaxis. In India, PDEV (Vaxirab) being manufactured in use since 2003. the present study, we have evaluated safety, immunogenicity tolerance of this vaccine with two other approved CCVs, viz., chick cell (PCEC, Rabipur) vero rabies (PVRV, Veroroab). This study was an open label, randomized phase IV comparative clinical trial. A total 152 people bitten dogs animals were recruited from 4 different centres India. They randomly assigned to receive one Essen intramuscular regimen (52 subjects received Vaxirab 50 each Rabipur Verorab) immunoglobulin also administered all category III exposures. Their blood samples collected on day 0 (prior vaccination), 14, 28, 90 180. Side effects if any monitored. The neutralizing antibody titers their estimated rapid fluorescent focus inhibition test (RFFIT). Subjects three groups had 14 (>0.5 IU/mL) geometric mean (GMT) observed days tested did not vary significantly (p > 0.5). minimal among groups. results indicate that as safe, tolerable immunogenic both PCEC (Rabipur) PVRV (Verorab). Thus can be good alternative CCVs

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