| CTRI Number |
CTRI/2024/02/063054 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative effectiveness of standrad versus double doses of hepatitis B vaccine in patients with chronic kidney disease |
|
Scientific Title of Study
|
Double-blind, placebo-controlled, randomized trial to compare antibody response to four
standard- versus double-dose schedule of hepatitis B vaccine in pre-dialysis patients with
eGFR<60 ml/min |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Goel |
| Designation |
Professor and Head of Hepatology Department |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) |
| Address |
Department of Hepatology;
5th Floor;
Center for Hepatobiliary Diseases and Liver Transplantation;
Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Raebareilly Road-226014
Lucknow
Department of Hepatology;
5th Floor;
Center for Hepatobiliary Diseases and Liver Transplantation;
Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Raebareilly Road-226014
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
919936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Goel |
| Designation |
Professor and Head of Hepatology Department |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) |
| Address |
Department of Hepatology;
5th Floor;
Center for Hepatobiliary Diseases and Liver Transplantation;
Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Raebareilly Road-226014
Lucknow
Department of Hepatology;
5th Floor;
Center for Hepatobiliary Diseases and Liver Transplantation;
Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Raebareilly Road-226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
919936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Goel |
| Designation |
Professor and Head of Hepatology Department |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) |
| Address |
Department of Hepatology;
5th Floor;
Center for Hepatobiliary Diseases and Liver Transplantation;
Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Raebareilly Road-226014
Lucknow
Department of Hepatology;
5th Floor;
Center for Hepatobiliary Diseases and Liver Transplantation;
Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Raebareilly Road-226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
919936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi, India (ICMR Project ID: IIRP-2023-2192/F1) |
|
|
Primary Sponsor
|
| Name |
Amit Goel |
| Address |
Professor and Head
Department of Hepatology
5th Floor
Liver Transplant Building
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow (UP)-226014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Amit Goel |
SGPGIMS |
Professor and Head
Department of Hepatology
5th Floor
Liver Transplant Building
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow (UP)-226014
Lucknow
UTTAR PRADESH |
919936275741
agoel.ag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGPGI Institute Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
Four doses (2.0 ml each) of recombinant hepatitis B vaccine will be administered intramusculalrly at 0,1, 2 and at 6 months. In one ml of vaccine contain 20 micro grams of antigen. Two injections of 1.0 ml each will be administered intramusculalrly in deltoid region, one in each arm. Participants will be followed upto 3 months after the administration of fourth dose of vaccine to test for anti-HBs titer. Each participant will be followed for a maximum duration of 9 months from the date of administration of the first dose of hepatitis B vaccine |
| Intervention |
Intervention arm |
Each participant will be given 1.0 ml vaccine and 1.0 ml sterile normal saline as placebo intramusculalrly at 0,1, 2 and at 6 months. In one ml of vaccine contain 20 micro grams of antigen. Both, vaccine and placebo, will be administered intramusculalrly in deltoid region in upper arms, both side (vaccine in one arm and placebo in another arm). Participants will be followed upto 3 months after the administration of fourth dose of vaccine to test for anti-HBs titer. Each participant will be followed for a maximum duration of 9 months from the date of administration of the first dose of hepatitis B vaccine
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. people with chronic kidney disease with estimated GFR between 60 and 15 ml per min
2. who are not on maintenance hemodialysis (MHD)
3. age between 19 and 65 years
4. are unlikely to need MHD in next 18 months
5. not received hepatitis B vaccination
6. HBsAg and anti-HBs antibody negative
7. body mass index (BMI) more than 18.5 Kg per M2
|
|
| ExclusionCriteria |
| Details |
1. Hepatitis C virus or HIV coinfection
2. Post-organ transplant recipients
3. On immunosuppressive medication, regardless of indication
4. Any immunodeficiency conditions
5. Presence of malignancy, regardless of its nature and stage of disease
6. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients who could achieve sero-protection, i.e. achieved anti-HBs titer ≥10 mIU per mL, following four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccine |
4-12 weeks after the administration of fourth dose of the vaccine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the proportion of patients who could achieve sero-conversion (anti-HBs antibody detected) after four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccine |
4-12 weeks after the administration of fourth dose of the vaccine |
| Compare the geometrical mean titer of anti-HBs antibody achieved after four standard or double doses of hepatitis B vaccine in those who could achieve seroprotection |
4-12 weeks after the administration of fourth dose of the vaccine |
| Identify the risk factors associated with poor vaccine response (seroconversion, seroprotection) |
4-12 weeks after the administration of fourth dose of the vaccine |
| Compare the qualitative and quantitative durability of vaccine induced antibody response (seroprotection as well as anti-HBs titer) at one year from the administration of first dose of the vaccine. |
12 to 15 months after the administration of first dose of vaccine |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Background: Chronic
kidney disease (CKD) is staged as I, ≥ 90; II, 60-89; III, 30-59; IV, 15-29; V,
<15 ml/min of eGR). Stage V patients require maintenance hemodialysis (MHD)
and are vaccinated with four 2.0 ml doses (0, 1, 2 and 6 months) of hepatitis B
vaccine. Standard vaccination schedule for healthy adults comprises of three
1.0 ml doses (0,1, and 6 months). In lack of data on vaccine efficacy in
pre-dialysis population, same recommendation is practiced for pre-dialysis CKD
patients also.
Novelty: This will be
first randomized controlled trial, with adequate power and sample size, in pre-dialysis
CKD patients.
Objective: To compare
the seroconversion, seroprotection, and anti-HBs antibody titers obtained with
1.0 ml versus 2.0 ml four dose schedule in pre-dialysis patients
Methods: Adult (n=400) with eGFR between 60 and 15 ml
per min, who are not on MHD, will be randomized in ‘Intervention arm’ (1.0 ml
vaccine plus 1.0 ml placebo at 0, 1, 2, and 6 months) or ‘Control arm’ (2 x 1.0
ml vaccine at 0, 1, 2, and 6 months). Serum anti-HBs titer will be measured at 4,
8, 12-24, 28-36, and 48-64 weeks from the first dose of vaccine. Anti-HBs titre
>10 mIU/mL at any time after four doses of vaccine will define seroprotection.
Expected
outcomes: Results will compare
the antibody response with standard or double dose of vaccine in pre-dialysis
patients. It will help us to estimate the additional benefit obtained by using extra
volume of vaccine in pre-dialysis population. |