| CTRI Number |
CTRI/2024/10/075093 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Rabies Vaccine Schedules: A Study on Two Different Pre-Exposure Methods |
|
Scientific Title of Study
|
Comparative Analysis of Pre-Exposure Prophylaxis (PrEP) Schedules for Rabies Vaccination : A Randomized Non-Inferiority Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMAN DEV SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Rajindra Hospital Patiala |
| Address |
40 Mohindra Complex New Officer Colony, Street No 2
Patiala
PUNJAB
147001
India |
| Phone |
7837809884 |
| Fax |
|
| Email |
adsingh44rssb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMAN DEV SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Rajindra Hospital Patiala |
| Address |
40 Mohindra Complex New Officer Colony, Street No 2
Patiala
PUNJAB
147001
India |
| Phone |
7837809884 |
| Fax |
|
| Email |
adsingh44rssb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMAN DEV SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Rajindra Hospital Patiala |
| Address |
40 Mohindra Complex New Officer Colony, Street No 2
Patiala
PUNJAB
147001
India |
| Phone |
7837809884 |
| Fax |
|
| Email |
adsingh44rssb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and Rajindra Hospital Sangrur Road ,Patiala,Punjab 147001 |
|
|
Primary Sponsor
|
| Name |
AMAN DEV SINGH |
| Address |
Government medical college and Rajindra Hospital Sangrur Road ,Patiala,Punjab 147001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rohit Batish |
New Acaedemic Building Department of Community Medicine |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAman Dev Singh |
Government Medical College and Rajindra Hospital,Patiala,Punjab |
OPD No-3,Anti Rabies Clinic Rajindra Hospital,
Patiala
PUNJAB
Patiala
PUNJAB |
7837809884
adsigh44rssb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Medical College,PATIALA-147001(PUNJAB)INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Rabies |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pre-Exposure prophylaxis as per WHO guidelines |
This group will receive 2 doses of Pre-Exposure anti Rabies vaccine at a dose of 0.1 ml on each deltoid on day 0 and 7 as per WHO guidelines. |
| Intervention |
Single visit 4 site Pre-Exposure Prophylaxis. |
This group will receive single visit 4 dose of anti-rabies vaccine at a dose of 0.1ml on each deltoid and each supraclavicular region. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Immunologically naive healthy human volunteers who have never received anti-rabies treatment in the past and are willing to give verbal consent will be included in study. |
|
| ExclusionCriteria |
| Details |
Those who have received anti-rabies treatment in the past whether complete or incomplete will be excluded from study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| analysis of rabies antibody Titre on day 28th by ELISA method for in both groups and comparison of differences in antibody titre if any. |
analysis of rabies antibody Titre on day 28th by ELISA method for in both groups and comparison of differences in antibody titre if any. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
01/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is aimed at comparing the different Pre-Exposure Prophylaxis schedule and find out the most practical and scientifically sound method.Current PrEP guidelines revised by WHO in 2018 recommends 2 visit for vaccination. This research aims to investigate whether a single visit PrEP could be as effective potentially eliminating need for Rabies Immunoglobulins which is hard to obtain in many regions. The research addresses WHO priority on optimising rabies vaccination in endemic regions. |