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CTRI Number  CTRI/2025/02/081059 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Vaccine
Other (Specify) [Hepatitis B vaccination by two different routes of administration. (Efficacy of vaccine)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Hepatitis B vaccination in hemodialysis patients  
Scientific Title of Study   An open label, non-inferiority randomized controlled trial of intradermal versus intramuscular administration of Hepatitis B vaccine in failed response to previous standard intramuscular schedule of Hepatitis B vaccination in patients of end stage renal disease on haemodialysis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tukaram Jamale 
Designation  Professor and Head of department 
Affiliation  Seth GSMC & KEM Hospital 
Address  34 A third floor, Department of Nephrology, Old building, KEM Hospital Parel, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9167460362  
Fax    
Email  tukaramjamale@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tukaram Jamale 
Designation  Professor and Head of department 
Affiliation  Seth GSMC & KEM Hospital 
Address  34 A third floor, Department of Nephrology, Old building, KEM Hospital Parel, Mumbai-400012


MAHARASHTRA
400012
India 
Phone  9167460362  
Fax    
Email  tukaramjamale@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sayali Thakare 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEM hospital, Mumbai 
Address  34 A third floor, Department of Nephrology, Old building, KEM Hospital Parel, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9702841818  
Fax    
Email  thakare.sayali@gmail.com  
 
Source of Monetary or Material Support  
Department of Nephrology Seth GSMC and KEM Hospital Parel Mumbai 400012 
 
Primary Sponsor  
Name  Seth GSMC and KEM Hospital 
Address  Ward 34A Third floor Department of Nephrology Old building Seth GSMC and KEM Hospital Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tukaram Jamale  KEM Hospital Mumbai  34 A third floor Department of Nephrology Old building KEM Hospital Parel Mumbai 400012 Parel, Mumbai-400012
Mumbai
MAHARASHTRA 		 9167460362

tukaramjamale@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hepatitis B vaccine [ID]  10 micro gram (0.5 ml) of Hepatitis B vaccine will be administered to the enrolled patients by trained qualified personnel intradermally at week 0, 1, 2, 3, 4, 5, 6 and 7. 
Comparator Agent  Hepatitis B vaccine [IM]  40 micro gram (2 ml) of Hepatitis B vaccine will be administered to the enrolled patients by trained qualified personnel intramuscularly at 0 month, 1 month, 2 month and 6 month interval. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Chronic kidney disease patients on MHD for a minimum of 3 months with age 18 years or above.
Have undergone a complete previous primary series of IM double dose vaccination i.e. 40 microgram of recombinant hepatitis B vaccine at 0, 1, 2 and 6 months after initiation of hemodialysis.
Previously vaccinated patients who currently have Anti-HbsAb titres less than 10mIU/ml.
Patients on regular follow up and complete records.
Patients agreeing to participate in this study by signing informed consent forms. 
 
ExclusionCriteria 
Details  CKD patients not on maintenance haemodialysis or on peritoneal dialysis.
Patients eligible for renal transplant within next 6 months.
Patients with anti-HBs antibody titres greater than 10 mIU/mL.
Patients found to be HbsAg positive
Vaccinated with any other vaccine within 2 weeks.
Patients who have been administered a booster dose of Hep B vaccine irrespective of timeline.
Patients not willing to participate in the study.
Pregnant or breastfeeding females.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the responses i.e. anti-HBsAb titres greater than 10 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination.
To compare the development of protective responses i.e. anti-HBsAb titres greater than 100 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination.
 		 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change in titres at predefined time points prior to completion of vaccination schedule i.e at Week 4 for ID and Month 3 for IM and at Week 12 for ID and Month 7 for IM.
To determine factors affecting response to vaccination.
 		 12 months 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/03/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 aims to investigate the effectiveness of intradermal versus intramuscular adminstration of Hepatitis B vaccine in patients with chronic kidney disease (CKD). The study is an open label, non-inferiority randomized controlled trial, focusing on patients who have already completed their primary vaccination schedule of 4 doses and have not developed any protective titres or those with very low (<10 mIU/ml). The study is part of CDC’s guidelines for CKD patients, which recommend a specific vaccine and schedule. The vaccine is generally given intramuscularly in the deltoid region of arm, with standard dose scheduled at 0, 1, 2 and 6 month intervals. While the intradermal route currently gaining attention will be studied simultaneously in the study population and the response to both vaccination methods along with factors, influencing the response will be studied. 
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