To compare the serum anti-HBs seroconversion rates in hematopoietic stem cell transplant (HSCT) recipients who receive three doses of the hepatitis B vaccine 12 months post-transplant (control group) versus those who receive it 6 months post-transplant (intervention group).
Design
A clinical trial with a control group, parallel groups, single-blind design, randomized, Phase 3 involving 440 patients. Randomization was conducted using STATA software.
Settings and conduct
The study will be conducted at the Stem Cell Therapy and HSCT Research Center, Shariati Hospital. The hepatitis B vaccine will be administered at the standard dose (20 µg) in three doses at 0, 1, and 6 months. HBs Ab levels will be measured using the ELISA method before the first vaccine dose, three weeks after the first dose, and one to two months after the third dose. Only the data analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age 18 years or older.
Underwent allogeneic or autologous HSCT.
At least 6 months have passed since the transplantation.
Negative HBs Ag and HBC Ab titers.
Exclusion Criteria:
Use of immunosuppressive medication.
Active GVHD grade 3 or 4.
History of chronic hepatitis B.
Prophylactic treatment with tenofovir due to positive HBc Ab.
Lack of consent
Intervention groups
In the control group, patients will receive the hepatitis B vaccination one year after transplantation, while in the intervention group, patients will receive it six months post-transplant, provided they do not receive immunosuppressive medications (no occurrence of GVHD)
Main outcome variables
HBs Ab titer
General information
Reason for update
Acronym
IHR-HBV-BMT-SH-RCT
IRCT registration information
IRCT registration number:IRCT20140818018842N45
Registration date:2025-01-19, 1403/10/30
Registration timing:prospective
Last update:2025-01-19, 1403/10/30
Update count:0
Registration date
2025-01-19, 1403/10/30
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-13, 1403/11/25
Expected recruitment end date
2027-02-14, 1405/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the immune response to hepatitis B vaccine in patients undergoing bone marrow transplantation: a randomized clinical trial
Public title
Study on the Immune Response to Hepatitis B Vaccine in Bone Marrow Transplant Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years old
Participants must have undergone either allogeneic or autologous bone marrow transplantation.
At least 6 months must have passed since the date of transplantation.
Hepatitis Test Results: Participants must have negative HBs Ag and HBC Ab titers.
Exclusion criteria:
Use of immunosuppressive medication
Active GVHD grade 3 and 4
History of chronic hepatitis B
Prophylactic treatment with tenofovir due to positive HBc Ab
Lack of consent
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
440
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocation to study groups will be designed in a parallel fashion, with Group A designated as the intervention group (receiving the hepatitis vaccine 6 months post-transplant) and Group B as the control group (receiving the hepatitis vaccine 12 months post-transplant). A balanced block randomization list will be generated using STATA software, after entering the number 440 as the sample size and considering blocks of 8. Based on this balanced block randomization list, a sequence of numbers will be created, and according to the list of transplanted patients in the research institute's registry, participants will be divided into two groups. Those who meet the inclusion criteria and provide written informed consent will receive the vaccine.
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study only data analyser is blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Research Institute of Oncology, Hematology, and Cell Therapy - Tehran Univer
Street address
Jaleh Al Ahmad St. North Kargar S ,Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2024-11-27, 1403/09/07
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1403.060
Health conditions studied
1
Description of health condition studied
Hepatitis B vaccine
ICD-10 code
Y59.0
ICD-10 code description
viral vaccine
2
Description of health condition studied
Bone marrow transplant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anti-HBs seroconversion
Timepoint
Before the administration of the first dose of the vaccine, three weeks after the first dose, and one to two months after the third dose.
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Patients in the intervention group will receive hepatitis B vaccinations, six months after transplantation, provided they are not receiving immunosuppressive medications (absence of GVHD). The hepatitis B vaccine is administered at the standard dose of 20 µg in three doses at 0, 1, and 6 months. HBS antibody levels will be measured using the ELISA method before the first vaccine dose, three weeks after the second dose, and one to two months following the third dose. Anti-HBS seroconversion is defined as having HBS antibody levels equal to or greater than 10 mIU/ml. If seroconversion does not occur after the three doses of the vaccine, a fourth dose should be administered, and HBS antibody levels will be measured one to two months later. For patients who still do not achieve adequate antibody levels after the fourth dose, two additional vaccine doses will be given, with antibody levels assessed one to two months after the last dose. If there is no antibody response, these patients will be classified as non-responders.
Category
Prevention
2
Description
Control group:In the control group, patients will receive hepatitis B vaccinations, one year after transplantation, provided they are not receiving immunosuppressive medications (absence of GVHD). The hepatitis B vaccine is administered at the standard dose of 20 µg in three doses at 0, 1, and 6 months. HBS antibody levels will be measured using the ELISA method before the first vaccine dose, three weeks after the second dose, and one to two months after the third dose.Anti-HBS seroconversion is defined as having HBS antibody levels equal to or greater than 10 mIU/ml. If seroconversion does not occur after the three doses of the vaccine, a fourth dose should be administered, and HBS antibody levels will be measured one to two months later. For patients who still do not achieve adequate antibody levels after the fourth dose, two additional vaccine doses will be given, with antibody levels assessed one to two months after the last dose. If there is no antibody response, these patients will be classified as non-responders.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Neda Alijani
Street address
Shariati hospital, North Kargar St
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
horcbmt@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd, Qods Square
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 912 697 2683
Email
ramin_kordi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
research specialist
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
ctu@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Alijani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
n-alijani@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohaddese Marzban
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 43, 5th St, Ashrafi Esfahani Ave.
City
Tehran
Province
Tehran
Postal code
1469665167
Phone
+98 21 4448 1081
Email
mhd.marzban@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available