Protocol summary

Study aim
Comparing safety and serological response following homologous vs. heterologous COVID-19 booster vaccine in patients receiving autologous hematopoietic stem cell transplants(AHSCT)
Design
This is a phase 2-3 double-blind, randomized controlled clinical trial to compare the serological response of the homologous COVID-19 vaccine versus the heterologous booster dose in 90 adult patients receiving AHSCT. For randomization, a balanced block randomization list was generated using the research institute's Web-based software, after entering the sample size and number of each block.
Settings and conduct
Eligible adult patients receiving AHSCT in a research institute for oncology, hematology, and cell therapy, will be invited four weeks (±7 days) after the 2nd dose. After obtaining the written informed consent, COVID-19 rapid test and antibody titer test will be performed, afterward, the national code enter into the system, and the vaccine code will be announced. The vaccine will be injected. Antibody titer and Side effects are evaluated four weeks (±7 days) after the vaccination.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age: 18-70 Time interval: 6 to 12 months after AHSCT Receiving two doses of Pastocovac vaccine, Exclusion criteria: Relapse of underlying disease
Intervention groups
Group A is a homologous vaccine (Pastocovac), and group B is a heterologous vaccine (Sinopharm ). In both groups, the rapid COVID-19 test will be performed, and then the blood sample will be tested to measure the COVID-19 antibody titer. The patient will randomly receive the vaccine, and after four weeks (±7 days), the patient's blood sample will test for antibody titer, and the vaccine's side effects will be recorded.
Main outcome variables
SARS-CoV-2 Anti SPIKE IgG titer three weeks (±7 days) following homologous versus heterologous booster vaccine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140818018842N24
Registration date: 2022-07-22, 1401/04/31
Registration timing: registered_while_recruiting

Last update: 2022-07-22, 1401/04/31
Update count: 0
Registration date
2022-07-22, 1401/04/31
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
2022-07-22, 1401/04/31
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the serological response to the heterologous versus homologous booster vaccinationin in patients receiving autologous hematopoietic stem cell transplantation
Public title
Evaluation of the serological response to booster vaccinationin in patients receiving autologous hematopoietic stem cell transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have undergone autologous hematopoietic stem cell transplantation Between 6 months and 12 months after transplantation They have received two initial doses of Pastocovac vaccine At least one month after receiving the second dose
Exclusion criteria:
Treatment with rituximab during last 6 months Relapse of underlying disease Positive rapid COVID-19 test before booster dose vaccination Patients who do not consent to vaccination
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning to the study groups is a parallel; group A is considered the intervention group of homologous vaccine (Pastocovac vaccine), and group B is the intervention group of heterologous vaccine (Sinopharm vaccine). The balanced block randomization list will be generated through the research institute's web-based software; after entering the sample size 90 and considering the block size of 4, according to this balanced block randomization list, a sequence of numbers is created, and this sequence of numbers is defined in the system. If the patients meet the criteria of the study after obtaining informed consent, their national code will be entered into the system, and the software will announce the code of each patient. Patients receive one of two vaccines randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to ethical considerations, a placebo arm will not be used. 10-dose vials of both types of vaccines are given to a person outside the research team. At pre-determined times when some patients come to inject a booster dose, each vial of 10-dose Sinopharm or Pastocococ vaccine is poured into ten insulin syringes as a single dose by the responsible person and is coded by the sequence of numbers according to a random list and considering the cold chain. The code label has already been prepared and is provided to that person. Coded vaccine syringes will be placed in a special refrigerator at a temperature of 2-4 degrees until the time of injection, which should be half an hour. Apart from the above person, all the research team members, including the Care provider, the person responsible for injecting the vaccine, the person responsible for collecting information, the analyst, and the patient, are not aware of the type of vaccine.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer
Street address
Kargar shomali Ave., Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1401.005

Health conditions studied

1

Description of health condition studied
Multiple myeloma
ICD-10 code
C90
ICD-10 code description
Multiple myeloma and malignant plasma cell neoplasms

2

Description of health condition studied
Non-Hodgkin lymphoma
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma

3

Description of health condition studied
Hodgkin lymphoma
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma

4

Description of health condition studied
Myelodysplastic syndrome
ICD-10 code
D46
ICD-10 code description
Myelodysplastic syndromes

Primary outcomes

1

Description
SARS-CoV-2 antibody titers
Timepoint
before the start of the intervention and 4 weeks (±7 days) after the injection of the booster dose vaccine
Method of measurement
ChemoBind SARS-CoV-۲ IgG Test

Secondary outcomes

1

Description
Probable Side effect: local pain, fever, fatigue, headache and sore throat
Timepoint
One week after vaccination
Method of measurement
Vaccine side effects checklist

Intervention groups

1

Description
Intervention group 1: injection of one homologous booster dose of Pastocovac 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly 0.5 ml into the deltoid muscle
Category
Treatment - Other

2

Description
Intervention group 2: injection of one heterologous booster dose of Sinopharm 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly 0.5 ml into the deltoid muscle
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Reseach Institute for Oncology ,Hematology and Cell Therapy, Tehran University of Medical Sci
Full name of responsible person
Maryam Barkhordar
Street address
Shariati hospital, Kargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
barkhordarm.n@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Vaezi
Street address
Shariati hospital, Kargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
vaezi.mohammad@yahoo.com
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 Assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Manoochehr Karami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Shahid Beheshti university of Medical Sciences School of Public Health and Safety, Shahid Shahriari Sq, Yaman St., Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 2040
Email
man.karami@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
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

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
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