NCT04723706

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Hematologic Disorders and Bone Marrow Failure, Hematopoietic Stem Cell Transplantation (HSCT) or Cellular Therapy (CART)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	COVID-19 serology IgG	patients with SCT or CART who decide to get their vaccines we 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

Timeline

• Start date: 2021-03-19
• Primary completion: 2023-12-02
• Completion: 2024-01-02
• First posted: 2021-01-26
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States