- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04723706
Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients
April 5, 2023 updated by: Shatha Farhan, Henry Ford Health System
Immunological Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients
For many patients with hematologic disorders and bone marrow failure, hematopoietic stem cell transplantation (HSCT) or cellular therapy (CART) offers a curative treatment option.
Patients after SCT or CART have a variable period of immune deficiency in the post-treatment period.
The response to vaccination may affect the outcome of the transplant patients.
the immunogenicity of vaccines in this immunosuppressed population is uncertain and variable.
HSCT and CAR-T recipients are in a COVID-19 high-risk group and conferring immunity by vaccination at the earliest effective timepoint is desirable.
At present, the immunogenicity and efficacy of SARS-CoV-2 vaccines in immune-impaired patients including autologous and allogeneic HSCT recipients is unknown.
Furthermore, the impact of GvHD and IST on SARS-CoV-2 vaccine immunogenicity is unknown.
the investigators aim to evaluate the vaccination response to COVID vaccines after SCT and CART
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
so for participants with SCT or CART who decide to get their vaccines, the investigators will measure response by therapy by measuring COVID-19 serology IgG at the following schedule: Baseline +5 days after vaccination; 1 month +/- 10 days (after the first dose), 2 months +/- 10 days (after the 2nd dose), 3 months +/- 10 days, 6 months +/- 10 days and 12 months +/- 10 days In addition, also the investigators will collect CD4 and Total IgG which is the standard of care of these patients post SCT and CART
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shatha Farhan, MD
- Phone Number: 313 713 3910
- Email: sfarhan1@hfhs.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
any SCT or CART post COVID vaccine
Description
Inclusion Criteria:
- any SCT or CART post COVID vaccine
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine
Time Frame: up to one year post vaccine
|
up to one year post vaccine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2021
Primary Completion (Anticipated)
April 1, 2024
Study Completion (Anticipated)
April 1, 2024
Study Registration Dates
First Submitted
January 20, 2021
First Submitted That Met QC Criteria
January 20, 2021
First Posted (Actual)
January 26, 2021
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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