Protocol summary
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Study aim
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Evaluation of the immunologic effects of COVID-19
vaccination following autologous stem cell transplantation
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Design
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A phase 2 controlled clinical trial on
62 transplanted patients and 62 healthy people enrolled between 01/1401 and
11/1401 and followed for one year.
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Settings and conduct
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The study would be conducted at the Hematology-Oncology and Stem Cell Transplantation Research Center of Tehran University. All subjects will receive two doses of pastocovac and a booster dose at four weeks (±7 days) intervals starting from 3 months post-transplant. The efficacy of post- HSCT vaccination will be assessed through serologic responses by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
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Participants/Inclusion and exclusion criteria
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All consecutive adult patients more than 18 years old who underwent autologous SCT and agree to receive post-transplant COVID-۱۹ vaccines, provided they do not receive Rituximab for the past six months.
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Intervention groups
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All patients who underwent autologous SCT and have inclusion criteria will be enrolled and will receive the first dose of pastocovac from 3 months post-transplant. The second dose will receive at four weeks (±7 days) interval of the first dose and the booster will receive at four weeks (±7 days) interval of the second dose. The serologic responses will be assessed by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
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Main outcome variables
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SARS-CoV-2 vaccine immunologic response by measuring SARS-CoV-2 IgG (anti-S1) titer at four weeks post second COVID-19 vaccine than pre vaccination titer in autologous HSCT recipients compared to a healthy population
General information
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Reason for update
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Adding a healthy control group to compare the serological response following vaccine between transplanted recipients with the healthy group
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Acronym
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ESVَََAHSCT
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IRCT registration information
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IRCT registration number:
IRCT20140818018842N23
Registration date:
2022-04-03, 1401/01/14
Registration timing:
registered_while_recruiting
Last update:
2022-08-21, 1401/05/30
Update count:
1
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Registration date
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2022-04-03, 1401/01/14
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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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2022-04-03, 1401/01/14
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Expected recruitment end date
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2023-02-03, 1401/11/14
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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 SARS-CoV-۲ Vaccine (Pastocovac) effectiveness and serologic response in Patients Receiving Hematopoietic Autologous Stem Cell Transplantation compared to control group: A clinical trial
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Public title
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Evaluation of the Pastocovac (COVID-19 vaccine) efficacy following autologous 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:
َAll autologous stem cell transplantation
Age >=18
Exclusion criteria:
patients who received Rituximab during the past six months.
Patients who do not consent to vaccination after transplantation
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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:
124
More than 1 sample in each individual
Number of samples in each individual:
4
Sampling for SARS-CoV-2 specific IgG (anti-S1) titers in post autologous transplantation, as well in a healthy population, as follows: before the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
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Randomization (investigator's opinion)
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Not randomized
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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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Parallel
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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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2022-03-15, 1400/12/24
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Ethics committee reference number
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IR.TUMS.HORCSCT.REC.1400.035
Health conditions studied
1
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Description of health condition studied
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Autologous stem cell transplantation
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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SARS-CoV-2 vaccine efficacy
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ICD-10 code
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ICD-10 code description
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SARS-CoV-2 vaccine effectiveness
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
Secondary 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 first 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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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
Intervention groups
1
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Description
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Intervention group: All patients who underwent autologous SCT and have inclusion criteria will be enrolled and will receive the first dose of pastocovac from 3 months post-transplant. The second dose will receive at four weeks (±7 days) interval of the first dose and the booster will receive at four weeks (±7 days) interval of the second dose. The serologic responses will be assessed by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
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Category
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Prevention
2
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Description
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Control group: The control group includes healthy people who have received two doses of Pastococcal vaccine with the same formula and dose as the intervention group, and the antibody titer is measured before and after each dose of the vaccine
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Category
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Prevention
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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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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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information"
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available