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OpenTrials
Completed

NCT Number: NCT04723706

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any SCT or CART post COVID vaccine

Exclusion criteria

  • none

Treatment and study plan

COVID-19 serology IgG

Diagnostic Test

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

Primary outcomes

  1. estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine

    Time frame: up to one year post vaccine

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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