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

NCT06066294 | Unknown Phase 3

• 1 other identifier: KIMSCM01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Regimen 1

EXPERIMENTAL

WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7

Biological: Regimen 1

Regimen 2

ACTIVE COMPARATOR

Government of India currently recommended PrEP Schedule, 0.1ml 3 visits, on day 0, day 7 and day 28

Biological: Regimen 2

Interventions

Regimen 1 BIOLOGICAL

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

Regimen 1

Regimen 2 BIOLOGICAL

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

Regimen 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects willing to volunteer and sign written informed consent for the study.
• Subjects should be available for the follow-up period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kempegowda Institute of Medical Sciences, Bangalore: lead

Study Sites (1)

Kempegowda Institute Of Medical Sciences Hospital and Research Center

Bengaluru, Karnataka, 560002, India

RECRUITING

Study Officials

• Deekshith J Reddy, MBBS

  Kempegowda Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramesh NR Masthi, MBBS, MD

CONTACT

+919845759992; ramesh.masthi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Department, Department of Community Medicine

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: April 3, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

IN (1)