| CTRI Number |
CTRI/2024/07/071408 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Better Rabies Shots: Which Method Works Best? |
|
Scientific Title of Study
|
Enhancing Rabies Immunity: A Comparative Study of Antibody Responses Post-3rd Vaccine Dose with Different Immunoglobulin Approaches. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMANDEV SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Rajindra Hospital Patiala |
| Address |
New Academic Building, 1st Floor Department of Community Medicine,GMC Patiala Punjab
New Academic Building, 1st Floor Department of Community Medicine,GMC Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
7837809884 |
| Fax |
|
| Email |
adsingh44rssb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMANDEV SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Rajindra Hospital Patiala |
| Address |
New Academic Building, 1st Floor Department of Community Medicine,GMC Patiala Punjab
New Academic Building, 1st Floor Department of Community Medicine,GMC Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
7837809884 |
| Fax |
|
| Email |
adsingh44rssb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMANDEV SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Rajindra Hospital Patiala |
| Address |
New Academic Building, 1st Floor Department of Community Medicine,GMC Patiala Punjab
New Academic Building, 1st Floor Department of Community Medicine,GMC Patiala Punjab
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 |
AMANDEV SINGH |
| Address |
Government medical college and Rajindra Hospital Sangrur Road ,Patiala,Punjab 147001 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 |
| Aman Dev Singh |
Government Medical College and Rajindra Hospital,Patiala,Punjab |
Anti Rabies Clinic OPD no -3
Patiala
PUNJAB |
7837809884
adsingh44rssb@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 |
| Patients |
(1) ICD-10 Condition: A829||Rabies, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Weigh based rabies immunoglobulin |
We will give weight based immunoglobulin in one group and 4 dose anti rabies vaccine and antibody titre estimation on day 14th i.e 7 days after 3rd vaccine.Total period-28 days |
| Intervention |
Wound only Rabies immunoglobulin |
We will give wound only rabies immunoglobulin in one group with 4 dose anti rabies vaccine and estimation of antibody titre on 14th day i.e 7 days after 3rd dose.Total period 28 days |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All new cases of animal bites with no prior history of exposure to animal bite and willing to continue treatment from our Centre will be included in study. |
|
| ExclusionCriteria |
| Details |
1) Those patients found reactive to equine immunoglobulin test dose.
2) Individuals with compromised immune systems.(HIV/TB/RA/DM/HCV/others)
3) Pregnant women.
4) Previous documented immunization against rabies.
5) Patients not adhering to ARV schedule as prescribed will be excluded.
6) Referred from other Centre for only RIG infiltration. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antibody titres via RFFIT on day 14 i.e 7 days after 3rd dose of anti rabies vaccine. |
Antibody titres via RFFIT on day 14 i.e 7 days after 3rd dose of anti rabies vaccine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of antibody titre amongst group receiving wound only RIG compared to group receiving weight based RIG. |
After receiving antibody titre results |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Rabies is a 100% fatal yet 100% vaccine preventable disease of central nervous system.Globally and especially in India cases of animal bite are on the rise with an estimated 55000 deaths globally and 20000 alone in India.The high number of deaths can be attributed to lack of awareness about management and seriousness of disease amongst people and also due to non adherence to post exposure prophylaxis which involves 4 dose of anti rabies vaccine with or without RIG over a period of 1 month. National immunization technical advisory group are advised to review their policies for post exposure prophylaxis and consider adopting intradermal vaccination of shorter duration of 0,3 and 7 as recommended by pasteur institute of cambodia reducing time of schedule from 1 month to 1 week by eliminating 4th dose which is also the most commonly missed dose by patients as advocated by many studies.Also Who in its position paer on Rabies in April 2018 has again advocated for wound only infiltration of RIG/RMAB which not only saves biologicals and patients but is also non inferior to giving any remaining RIG in site distant from site of bite which results in wastage of biologicals. With above in mind we wish to evaluate - 1) Estimation of Antibody titre on day 14 by RFFIT with weight based RIG in one group and wound based RIG in another. 2) To know socio demographic profile and treatment seeking behaviour amongst these patients. |