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

Status: Unknown
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• Healthy subjects willing to volunteer and sign written informed consent for the study.

• Subjects should be available for the follow-up period.

Locations
Other Locations
India
Kempegowda Institute Of Medical Sciences Hospital and Research Center
RECRUITING
Bengaluru
Contact Information
Primary
Ramesh NR Masthi, MBBS, MD
ramesh.masthi@gmail.com
+919845759992
Time Frame
Start Date: 2023-04-03
Completion Date: 2024-11
Participants
Target number of participants: 115
Treatments
Experimental: Regimen 1
WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7
Active_comparator: Regimen 2
Government of India currently recommended PrEP Schedule, 0.1ml 3 visits, on day 0, day 7 and day 28
Related Therapeutic Areas
Sponsors
Leads: Kempegowda Institute of Medical Sciences, Bangalore

This content was sourced from clinicaltrials.gov