Clinical Research Directory

A Comparison of Safety and Immunogenicity of Rabies Pre Exposure Prophylaxis Regimen Between Gvt of India Approved and WHO Approved.

Sponsor: Kempegowda Institute of Medical Sciences, Bangalore

Summary

The goal of this clinical trial is to compare WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 and Government of India currently recommended PrEP Schedule, 0.1ml 3 doses on day 0, day 7 and day 28 in Healthy subjects above 18years of age, willing to volunteer and sign written informed consent for the study. The main questions it aims to answer are: * To assess the seroconversion (? 0.5 IU/mL) of the study subjects following primary \& boosting vaccination on Day 35 ,Day 365, Day 372/375. * To assess the incidence of adverse events(immediate/delayed, local/systemic) among subjects. Participants will be administerd with WHO Pre-qualified rabies vaccine (Rabivax-S) . Researchers will compare the two regimens mentioned above.

Official title: A Randomized Controlled Trial on Safety and Immunogenicity of Purified Verocell Rabies Vaccine as Pre-exposure Prophylaxis Via Intradermal Two Visits (2-0-2-0-0) Verses Three Visits (1-0-1-0-1) Regimen on Healthy Volunteers

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