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

Primary Purpose

Vaccine Reaction

Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Regimen 1
Regimen 2
Sponsored by
Kempegowda Institute of Medical Sciences, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccine Reaction focused on measuring Immunogenicity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kempegowda Institute Of Medical Sciences Hospital and Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regimen 1

Regimen 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2023
Last Updated
October 4, 2023
Sponsor
Kempegowda Institute of Medical Sciences, Bangalore
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1. Study Identification

Unique Protocol Identification Number
NCT06066294
Brief Title
A Comparison of Safety and Immunogenicity of Rabies Pre Exposure Prophylaxis Regimen Between Gvt of India Approved and WHO Approved.
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kempegowda Institute of Medical Sciences, Bangalore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will be conducted among healthy adult volunteers visiting the Anti Rabies Clinic, Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital& Research Centre, Bangalore and visits to other institutes/places in bangalore. Step-1: Selection of Volunteers: The healthy volunteers who agreed to participate in the study will be screened for the inclusion and exclusion criteria and subsequently explained regarding the vaccination regimen, benefits due to vaccine and informed consent will be taken. The selected volunteers will be randomized into two groups-study and control group. Step-2: Collection of Data: A pre tested semi structured questionnaire will be used for collection of data about Socio demographic profile and other related variables. Step-3: Vaccination of Volunteers: The volunteers will be given WHO Pre-qualified rabies vaccine (Rabivax-S, purchased from open market) 0.1ml each in 2 sites on Day 0 & 7 intradermal for the study group and 0.1 ml of rabies vaccine at 1 site intradermal route on Day 0, 7 & 28 for the control group. Later, in each group, 50% of the subjects will be provided a booster dose of vaccine i.e. 0.1 ml, one site on day 365(one visit); for another 50 % of the subjects, booster dose of vaccine i.e. 0.1 ml, one site on days 365 and 368(two visits). Step 4: Safety evaluation: After each vaccination dose, subject will be observed for an hour, to find out any adverse drug reactions (ADRs) and then, a follow-up card will be given to enter any ADRs during the entire period of vaccination and one week after the last dose. All the reported ADRs will be recorded and analysed. The adverse events will be classified according to the revised adverse events following immunization (AEFI) guidelines.12 Step 5: Collection of Sample and immunogenicity analysis: 5ml of venous blood will be collected from the ante-cubital vein on day-0 (before vaccination), day-35 (after last dose of vaccination) 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 samples collected from the volunteers are centrifuged, serum separated and stored in -200 Centigrade at the Anti Rabies Clinic, Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital& Research Centre, Bangalore. The serum will be transported in cold chain to 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, where the Rapid fluorescent focus inhibition test (RFFIT) is done to estimate RVNA titres. The results obtained from RFFIT will be shared to the volunteers. Information regarding next dose and sample collection will be given to the subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Reaction
Keywords
Immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1
Arm Type
Experimental
Arm Description
WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7
Arm Title
Regimen 2
Arm Type
Active Comparator
Arm Description
Government of India currently recommended PrEP Schedule, 0.1ml 3 visits, on day 0, day 7 and day 28
Intervention Type
Biological
Intervention Name(s)
Regimen 1
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Regimen 2
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess the seroconversion (>0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375.
Description
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.
Time Frame
Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramesh NR Masthi, MBBS, MD
Phone
+919845759992
Email
ramesh.masthi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deekshith J Reddy, MBBS
Organizational Affiliation
Kempegowda Institute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kempegowda Institute Of Medical Sciences Hospital and Research Center
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramesh NR Masthi, MBBS, MD
Phone
+919845759992
Email
ramesh.masthi@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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