Protocol summary
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Study aim
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Evaluation of the immunologic effects of COVID-19 vaccination following allogeneic stem cell transplantation
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Design
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A single-arm, phase 2 clinical study to assess the efficacy of the COVID-19 vaccine following allogeneic HSCT on 40 consecutive patients enrolled between 01/2022 and 09/2022 and followed for one year
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Settings and conduct
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َAll patients who underwent allo-HSCT at the Stem Cell Transplantation Research Center of Tehran University are enrolled from 3 to 12 months after Allo-HSCT and are vaccinated with the three doses of Pastucovac. SARS-CoV-2 specific IgG (anti-S1) and immune subsets reconstitution are measured to assess the immune response.
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Participants/Inclusion and exclusion criteria
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All recipients of Allo-HSCT who meet the criteria, including; "age ≥ 18 years, successfully engraftment with full donor chimerism, absence of grade 3,4 acute GvHD or severe extensive chronic GvHD, no receive more than 0.5 mg/kg prednisolone, and no positive RT-PCR test for COVID-19 during the last three months" are enrolled to study from 3 to 12 months after Allo-HSCT.
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Intervention groups
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All patients who underwent allo-HSCT and have inclusion criteria are enrolled from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. The blood samples are collected before the first vaccine and three weeks (± one week) after each dose of vaccine to assess serologic response.
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Main outcome variables
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To assess the serologic response, by measurement of SARS-CoV-2 binding antibody titer 3-week (±7 days) after the second dose of vaccine; To describe vaccine-related adverse reactions until 14 days after administration of each vaccine dose.
General information
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Reason for update
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Adding Pasture Institute of Iran as one of the study"s sponsors
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Acronym
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ESVIRHSCT
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IRCT registration information
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IRCT registration number:
IRCT20140818018842N22
Registration date:
2022-01-12, 1400/10/22
Registration timing:
prospective
Last update:
2022-05-31, 1401/03/10
Update count:
2
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Registration date
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2022-01-12, 1400/10/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-15, 1400/10/25
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Expected recruitment end date
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2022-10-23, 1401/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of safety and immunogenicity of the SARS-CoV-2 recombinant spike RBD protein vaccine in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial
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Public title
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Evaluation of the COVID-19 vaccine efficacy following allogeneic stem cell transplantation
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Allogeneic stem cell transplantation
successfully engraftment with full donor chimerism
Age >=18
between 3 to 12 months after Allo-HSCT
Exclusion criteria:
grade 3,4 acute GvHD or severe extensive chronic GvHD
Patients who do not consent to vaccination after transplantation
receive more than 0.5 mg/kg/day prednisolone
positive RT-PCR test for COVID-19 during the last three months
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
4
Sampling for SARS-CoV-2 specific IgG (anti-S1) titers will be performed for recipients of allo-HSCT before the conditioning regimen, prior to the first vaccine, and three weeks (± one week) after each dose of vaccine.
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-29, 1400/08/07
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Ethics committee reference number
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IR.TUMS.HORCSCT.REC.1400.021
Health conditions studied
1
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Description of health condition studied
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Allogeneic stem cells transplantation
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ICD-10 code
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Z94.84
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ICD-10 code description
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Stem cells transplant status
Primary outcomes
1
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Description
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SARS-CoV-2 specific IgG (anti-S1) titer
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Timepoint
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four weeks after the second vaccine
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Method of measurement
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ٍٍEnzyme-linked immunosorbent assay
2
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Description
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B lymphocyte count
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Timepoint
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Three months after allogeneic transplantation
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Method of measurement
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multicolor flow cytometry
3
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Description
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NK cell count
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Timepoint
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Three months after allogeneic transplantation
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Method of measurement
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multicolor flow cytometry
4
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Description
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T cell count
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Timepoint
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Three months after allogeneic transplantation
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Method of measurement
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multicolor flow cytometry
5
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Description
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Cumulative incidence of COVID-19
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Timepoint
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12 months following bone marrow transplantation
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Method of measurement
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RT-PCR test
6
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Description
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Acute graft versus host disease
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Timepoint
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100 days following bone marrow transplantation
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Method of measurement
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Physical exam, biopsy, lab test
7
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Description
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Overall survival
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Timepoint
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12 months following bone marrow transplantation
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Method of measurement
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electronic data bank
Secondary outcomes
1
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Description
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Overall survival
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Timepoint
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One-year post transplantation
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Method of measurement
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Time
2
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Description
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Acute Graft versus Host Disease
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Timepoint
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100 days post-transplantation
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Method of measurement
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physical exam, lab test, and biopsy
3
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Description
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Relapse
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Timepoint
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One-year post-transplantation
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Method of measurement
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bone marrow aspiration and biopsy
Intervention groups
1
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Description
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All consecutive adult patients who are candidates for Allo-HSCT at HORCSCT are recruited. They sign an informed consent to administer the Pastocovac vaccine and take blood samples. All patients who meet the inclusion criteria are enrolled to study from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. Peripheral blood samples are collected before conditioning and before the first dose of vaccine to test particular lymphocyte subpopulations and SARS-CoV-2 IgG titers. The blood samples are also collected three weeks (± one week) after each dose of vaccine to assess serologic response by SARS-CoV-2 IgG titer.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Pasture Institute of Iran
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Proportion provided by this source
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30
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available