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

NCT06066294 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

  • Vaccine Reaction

Interventions

BIOLOGICAL

Regimen 1

WHO Pre-qualified rabies vaccine (Rabivax-S), WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7

BIOLOGICAL

Regimen 2

WHO Pre-qualified rabies vaccine (Rabivax-S), Government of India approved vaccination schedule, 3 visits, 0.1ml 1 site on day 0, 7 and 28

Sponsors & Collaborators

  • Kempegowda Institute of Medical Sciences, Bangalore

    lead OTHER_GOV

Principal Investigators

  • Deekshith J Reddy, MBBS · Kempegowda Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2023-11-30
Completion
2024-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06066294 on ClinicalTrials.gov