Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04723706 |
| Other study ID # |
14632 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 19, 2021 |
| Est. completion date |
January 2, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Henry Ford Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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
