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

Evaluation of safety and immunogenicity of the SARS-CoV-2 recombinant spike RBD protein vaccine in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N22

Enrollment

Registered

2022-01-12

Start date

2022-01-15

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic stem cells transplantation. Stem cells transplant status

Interventions

All consecutive adult patients who are candidates for Allo-HSCT at HORCSCT are recruited. They sign an informed consent to administer the Pastocovac vaccine and take blood samples. All patients who me

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeyla Sharifi Aliabadi

Tehran University of Medical Sciences

ctu@sina.tums.ac.ir00982288004140

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026