Evaluation of SARS-CoV-2 Vaccine Effectiveness and serologic response in Patients Receiving Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial
Evaluation of the immunologic effects of COVID-19 vaccination following allogeneic stem cell transplantation
Design
A single-arm, phase 2 clinical study to assess the efficacy of the COVID-19 vaccine following allogeneic HSCT on 100 consecutive patients enrolled between 01/2022 and 09/2022 and followed for one year
Settings and conduct
َAll consecutive adult patients who are a candidate for transplant at the Stem Cell Transplantation Research Center will be enrolled. Patients will receive two doses of COVID-19 vaccines at 3 and 4 months post-transplant according to the EBMT recommendation (version 7.0). SARS-CoV-2 specific IgG (anti-S1) and immune subsets reconstitution will be measured to assess the immune response.
Participants/Inclusion and exclusion criteria
All patients >=18 years
recipient of allogeneic stem cells transplant (ASCT)
A transplant from a related or unrelated donor
A transplant from HLA-matched or mismatched
Intervention groups
All consecutive patients who are a candidate for ASCT and agree to receive post-transplant COVID-19 vaccines will be enrolled. From 3 months post-transplant in the absence of grade 3,4 acute GVHD, patients will receive an approved COVID-19 vaccine according to the EBMT guideline (version 7.0) and a second dose will receive after four weeks (±7 days) interval. The serologic response will be assessed by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
Main outcome variables
SARS-CoV-2 vaccine effectiveness by measuring of SARS-CoV-2 IgG (anti-S1) titer at 4 weeks post second COVID-19 vaccine;
Measuring how early Immune cells reconstitution at 3 months post-HSCT (T cells, NK cells, B cells) could predict the response to the covid-19 vaccine.
General information
Reason for update
Acronym
ESVIRHSCT
IRCT registration information
IRCT registration number:IRCT20140818018842N22
Registration date:2022-01-12, 1400/10/22
Registration timing:prospective
Last update:2022-01-12, 1400/10/22
Update count:2
Registration date
2022-01-12, 1400/10/22
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
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of SARS-CoV-2 Vaccine Effectiveness and serologic response in Patients Receiving Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial
Public title
Evaluation of the COVID-19 vaccine efficacy following allogeneic stem cell transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Allogeneic stem cell transplantation
Related or unrelated donor
Age >=18
Matched or mismatched HLA typing between patients and donors
malignant and non-malignant underline disease
Exclusion criteria:
Patients who are not candidates for the COVID-19 vaccine after transplantation due to severe complications.
Patients who do not consent to vaccination after transplantation
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 prior to the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-10-29, 1400/08/07
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1400.021
Health conditions studied
1
Description of health condition studied
Allogeneic stem cells transplantation
ICD-10 code
Z94.84
ICD-10 code description
Stem cells transplant status
Primary outcomes
1
Description
SARS-CoV-2 specific IgG (anti-S1) titer
Timepoint
four weeks after the second vaccine
Method of measurement
ٍٍEnzyme-linked immunosorbent assay
2
Description
B lymphocyte count
Timepoint
Three months after allogeneic transplantation
Method of measurement
multicolor flow cytometry
3
Description
NK cell count
Timepoint
Three months after allogeneic transplantation
Method of measurement
multicolor flow cytometry
4
Description
T cell count
Timepoint
Three months after allogeneic transplantation
Method of measurement
multicolor flow cytometry
5
Description
Cumulative incidence of COVID-19
Timepoint
12 months following bone marrow transplantation
Method of measurement
RT-PCR test
6
Description
Acute graft versus host disease
Timepoint
100 days following bone marrow transplantation
Method of measurement
Physical exam, biopsy, lab test
7
Description
Overall survival
Timepoint
12 months following bone marrow transplantation
Method of measurement
electronic data bank
Secondary outcomes
1
Description
Overall survival
Timepoint
One-year post transplantation
Method of measurement
Time
2
Description
Acute Graft versus Host Disease
Timepoint
100 days post-transplantation
Method of measurement
physical exam, lab test, and biopsy
3
Description
Relapse
Timepoint
One-year post-transplantation
Method of measurement
bone marrow aspiration and biopsy
Intervention groups
1
Description
All consecutive patients who are a candidate for ASCT and agree to receive post-transplant COVID-19 vaccines will be enrolled. From three months post-transplant in the absence of grade 3,4 acute GVHD, patients will receive an approved COVID-19 vaccine according to the EBMT guideline (version 7.0) and a second dose will receive after four weeks (±7 days) interval. The serologic response will be assessed by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Maryam Barkhordar
Street address
Shariati hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Street address
Shariati hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
+98 21 8800 4140
Email
mbarkhordar@sina.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 Assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
00982288004140
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
Maryam Barkhordar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
mbarkhordar@sina.tums.ac.ir
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 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