Comparing the level of protection induced by giving two different vaccination schedules for dog bites among healthy volunteers in India. A multi Centre study
- Registration Number
- CTRI/2023/10/058418
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a) Healthy males or females
b) Aged between 18 to 45 years
c) Willing to give blood samples on days 0,14,28,42,180 and 365
a) History of dog bite
b) History of rabies immunization
c) Anti-malarial drug treatment during the last two months
d) Treatment with parenteral or oral steroids / immunosuppressive drugs during the last two months
e) Receiving immunoglobulins
f) Suffering from an autoimmune disease or any other immunological disorder
g) History of hypersensitivity to any vaccine
h) History of drug abuse or alcohol abuse
i) Psychological condition rendering the volunteer unable to understand the nature, scope, and consequence of the study
j) Participation in other investigational trials at the same time
k) Pregnant women and lactating mothers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary outcome measure will be geometric mean titres of Rabies Virus Neutralizing Antibody on Day 42 from the start of the vaccination scheduleTimepoint: On Day 42 from the start of the vaccination schedule
- Secondary Outcome Measures
Name Time Method Geometric mean titres of Rabies Virus Neutralizing Antibody ConcentrationsTimepoint: on Day Days 14, 28, 180 & 365 from start of the vaccination schedule;Safety outcome measures will comprise of solicited post-vaccination reactions, vaccine-related SAEs, & unsolicited vaccine-related AEsTimepoint: pre-defined time points from vaccination till 4 weeks after last vaccine dose.;Seroconversion rates (Rabies Virus Neutralizing Antibody Concentrations Equal & Above 0.5 IU/ml)Timepoint: on Days 14, 28, 42, 180 & 365 from the start of the vaccine schedule