Clinical trial
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
Name
KIMSCM01
Description
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.
Trial arms
Trial start
2023-04-03
Estimated PCD
2023-11-01
Trial end
2024-11-01
Status
Recruiting
Phase
Early phase I
Treatment
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
Arms:
Regimen 1
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
Arms:
Regimen 2
Size
115
Primary endpoint
To assess the seroconversion (>0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375.
Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375
Eligibility criteria
Inclusion Criteria:
* Healthy subjects willing to volunteer and sign written informed consent for the study.
* Subjects should be available for the follow-up period.
Exclusion Criteria:
* Received Anti rabies vaccine or RIG or RMAb anytime in the past.
* Participation in any other clinical trial in the past three months.
* Severely immunocompromised subjects, pregnant and lactating women.
* Subjects with known history of allergy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 115, 'type': 'ESTIMATED'}}
Updated at
2023-10-06
1 organization
2 products
1 indication
Product
Regimen 1Indication
Adverse Reaction to ImmunizationProduct
Regimen 2