Vaccine Reaction Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 115 |
Est. completion date | November 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Kempegowda Institute Of Medical Sciences Hospital and Research Center | Bengaluru | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Kempegowda Institute of Medical Sciences, Bangalore |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the seroconversion (>0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375. | 5ml of venous blood will be collected from the ante-cubital vein on day-0 (before vaccination), day-35 and day 365. For subjects who have received 0.1 ml booster dose on day 365, 5ml blood sample will be collected on day 372 and for those subjects, who have received 0.1ml booster dose on day 365 and 368, 5ml blood sample will be collected on day 375 to estimate rabies virus neutralizing antibody(RVNA) titres. The Rapid fluorescent focus inhibition test (RFFIT) is done at the Department of Neurovirology, National Institute of Mental Health and Neuro Sciences, Bangalore which is the WHO collaborating centre for reference and research on rabies, to estimate RVNA titres. The results obtained from RFFIT will be shared to the volunteers. | Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375 |
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