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Clinical Trial Summary

COVID-19 vaccinations are predicted to be a huge success in pandemic control. However, the majority of the studies were conducted on healthy individuals, and the efficiency of COVID-19 vaccination in post-transplant patients is uncertain. In the setting of HSCT, the extreme immunosuppression caused by the conditioning regimen and the graft versus host disease (GvHD) preventive regimen clearly has an impact on the efficacy and immunogenicity of the COVID-19 vaccine. The purpose of this single-center observational study is to analyze the immunological reconstitution and anti-S1 IgG serologic response to COVID-19 vaccination in post-transplant patients. In addition, factors correlated with a poor or good response to vaccination will be found. The findings of this study will serve to guide future COVID-19 vaccination recommendations in this population, such as the optimal starting time, interval time, and so on.

Clinical Trial Description

From the start of the study until the sample size of 100 patients is attained, all consecutive adult patients at the Hematology, Oncology, and Stem Cell Transplantation Research Center who are transplant candidates and agree to receive post-transplant COVID-19 vaccine will be enrolled. Patients will receive COVID-19 vaccines beginning 3 months after transplantation, according to the EBMT guideline (version 7.0), and immune response will be assessed by measuring SARS-CoV-2 specific IgG (anti-S1) and immune subsets count at the following schedule: SARS-CoV-2 specific IgG (anti-S1) will be assessed before conditioning regimen, before the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine. Multicolor flow cytometry will be used to quantify immune subsets such as T cells, NK cells, B cells, and dendritic cells before to HSCT as well as 30, 100, and 180 days after allogeneic HSCT. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05185817
Study type Observational [Patient Registry]
Source Tehran University of Medical Sciences
Contact Maryam Barkhordar, MD
Phone 0098 913 1856733
Email [email protected]
Status Recruiting
Start date November 1, 2021
Completion date July 1, 2023

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