Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04723706
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 24.4
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hematologic Disorders and Bone Marrow Failure, Hematopoietic Stem Cell Transplantation (HSCT) or Cellular Therapy (CART)	Diagnostic Test: COVID-19 serology IgG

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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immunological Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients
• Actual Study Start Date: Mar 19, 2021
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Outcome Measures

Primary Outcome Measures

1. estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine [up to one year post vaccine]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• any SCT or CART post COVID vaccine

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Health System	Detroit	Michigan	United States	48202

Sponsors and Collaborators

• Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shatha Farhan, MD clinical assistant professor, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT04723706
• Other Study ID Numbers: 14632
• First Posted: Jan 26, 2021
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shatha Farhan, MD clinical assistant professor, Henry Ford Health System: vaccine
• Additional relevant MeSH terms: Bone Marrow Failure Disorders; Pancytopenia; Hematologic Diseases

Study Results

No Results Posted as of Jul 21, 2022