| CTRI Number |
CTRI/2024/06/068665 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Antirabies vaccine using two dose ,two site subcutaneous route in children who are not exposed to rabies |
|
Scientific Title of Study
|
Immunogenicity of two dose, two site subcutaneous anti-rabies vaccine as a pre-exposure prophylaxis in children. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suriyanarayanan R |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 19A
Department of Pediatrics
Maulana Azad Medical College
2,Bahadurshah zafar marg, New Delhi -02.
New Delhi
DELHI
110002
India |
| Phone |
8870407065 |
| Fax |
|
| Email |
shaganshahsuriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Pediatrics,
Maulana Azad Medical College,
2,Bahadurshah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Pediatrics,
Maulana Azad Medical College,
2,Bahadurshah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College , New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
2,Bahadurshah Zafar Marg ,New Delhi -02 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suriyanarayanan R |
Lok Nayak Hospital |
Room No.516
Pediatrics OPD
Fifth Floor, OPD Building
Maulana Azad Medical college and Associated Lok Nayak Hospital.
New Delhi
DELHI |
8870407065
shaganshahsuriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals(Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research hospital, Guru nanak Eye Centre, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AntiRabies Vaccine |
Antirabies Vaccine will be administered as Two doses 0.1 ml each on Day 0 and Day 7 via Subcutaneous route on two sites over each Deltoid as Preexposure prophylaxis |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and Adolescents between 2 to 18 years presenting to Lok Nayak Hospital OPD for minor ailments. |
|
| ExclusionCriteria |
| Details |
1. Children with prior rabies immunization or history of animal bite.
2. Children with animal bite during the study period.
3. Children with known chronic illnesses.
4. Children receiving any vaccine less than a month ago.
5. Children on immunosuppressive drugs
6. Children with known Allergy to any of the components of the vaccine.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Proportion of children with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml after 2 doses of subcutaneous Pre-Exposure Rabies Prophylaxis on day 28 in children and adolescents between 2 to 18 years of age. |
On Day 28+7
where Day 0 is the day of first dose of Antirabies vaccine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of children with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml after 2 doses of subcutaneous Pre-Exposure Rabies Prophylaxis on day 90 in children & adolescents between 2 to 18 years of age.
2. Proportion of subjects having various kinds of adverse effects after two dose two site subcutaneous preexposure prophylaxis regimen using rabies cell culture vaccine.
|
On Day 90 plus 7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/06/2024 |
| Date of Study Completion (India) |
20/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Rabies is an infectious zoonotic viral disease that is almost always fatal following the onset of clinical symptoms. It remains a significant cause of mortality in many endemic countries in marginalized populations. World Health Organization (WHO) recommends Intramuscular (IM) or Intradermal (ID) routes of administration for Antirabies vaccine for Preexposure prophylaxis (PrEP) and Postexposure prophylaxis (PEP).Given the importance of preexposure prophylaxis of rabies in resource poor settings, it becomes inevitable to explore a cost friendly and technically feasible route of administration in these settings. Intramuscular route is costly and Intradermal route needs expertise to administer both of which are scarce in a country like India especially in peripheral and rural settings.Subcutaneous route doesn’t require highly skilled personnel as compared to ID route and can be administered even by ground level health care workers.
This is a single arm interventional study in assessing the immunogenicity of two dose two site Subcutaenous route of Antirabies vaccine as a Preexpsoure prophylaxis with primary outcome of protective titres of Antirabies Virus glycoprotein on day 28 and secondary outcome being protective titres on day 90 and proportion of subjects having adverse effects after vaccination.
This Study provides the necessary data in the utility of Subcutaneous route of Antirabies vaccine in resource poor settings. |