Comparing two rabies vaccination schedules for safety and immune response
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
This study is testing two different rabies vaccination schedules to see which one is safer and helps people build better immunity against the virus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kempegowda Institute of Medical Sciences, Bangalore Government |
| Locations | 1 site (Bengaluru, Karnataka) |
| Trial ID | NCT06066294 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and immunogenicity of two rabies pre-exposure prophylaxis (PrEP) regimens: one recommended by the Government of India and the other by the World Health Organization (WHO). Healthy adult volunteers will be randomized into two groups, receiving either the WHO-approved schedule or the Indian government schedule. The study will assess seroconversion rates and the incidence of adverse events following vaccination. Participants will be monitored for safety after each dose and followed up for a year to evaluate long-term immune response.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults over 18 years who are willing to participate and provide informed consent.
Not a fit: Patients who have previously received rabies vaccination or are severely immunocompromised, pregnant, or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize rabies vaccination protocols, potentially improving protection against rabies for individuals at risk.
How similar studies have performed: While there have been studies on rabies vaccination, this specific comparison of the two regimens is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bengaluru, Karnataka
- Kempegowda Institute Of Medical Sciences Hospital and Research Center — Bengaluru, Karnataka, India (Recruiting)
Study contacts
- Principal investigator: Deekshith J Reddy, MBBS — Kempegowda Institute of Medical Sciences
- Study coordinator: Ramesh NR Masthi, MBBS, MD
- Email: ramesh.masthi@gmail.com
- Phone: +919845759992
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.