Evaluation of the COVID-19 vaccine efficacy following allogeneic stem cell transplantatio

Phase 2

Recruiting

• Conditions: Allogeneic stem cells transplantation.; Stem cells transplant status; Z94.84

• Registration Number: IRCT20140818018842N22
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Allogeneic stem cell transplantation
successfully engraftment with full donor chimerism
Age >=18
between 3 to 12 months after Allo-HSCT

Exclusion Criteria

grade 3,4 acute GvHD or severe extensive chronic GvHD
Patients who do not consent to vaccination after transplantation
receive more than 0.5 mg/kg/day prednisolone
positive RT-PCR test for COVID-19 during the last three months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 specific IgG (anti-S1) titer. Timepoint: four weeks after the second vaccine. Method of measurement: ??Enzyme-linked immunosorbent assay.;B lymphocyte count. Timepoint: Three months after allogeneic transplantation. Method of measurement: multicolor flow cytometry.;NK cell count. Timepoint: Three months after allogeneic transplantation. Method of measurement: multicolor flow cytometry.;T cell count. Timepoint: Three months after allogeneic transplantation. Method of measurement: multicolor flow cytometry.;Cumulative incidence of COVID-19. Timepoint: 12 months following bone marrow transplantation. Method of measurement: RT-PCR test.;Acute graft versus host disease. Timepoint: 100 days following bone marrow transplantation. Method of measurement: Physical exam, biopsy, lab test.;Overall survival. Timepoint: 12 months following bone marrow transplantation. Method of measurement: electronic data bank.

Secondary Outcome Measures

Name	Time	Method
Overall survival. Timepoint: One-year post transplantation. Method of measurement: Time.;Acute Graft versus Host Disease. Timepoint: 100 days post-transplantation. Method of measurement: physical exam, lab test, and biopsy.;Relapse. Timepoint: One-year post-transplantation. Method of measurement: bone marrow aspiration and biopsy.