COVID-19 Vaccine in Patients After Allogeneic HCT, CAR-T Therapy and With Primary Immune Deficiency

NCT04724642 | Unknown

• 1 other identifier: 1067-20
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19). The purpose of the study is to confirm the accepted hypothesis from the recommendations of The European Society for Blood and Marrow Transplantation, that the vaccine for COVID-19 is safe and has good efficacy in immunocompromised patients after a bone marrow transplant from a donor / cellular therapy.

Conditions

Allogenic Hematopoietic Cell Transplant; CAR-T Therapy; Primary Immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of side effects in patients

  Incidence of side effects in patients post allogeneic bone marrow transplantation after COVID-19 vaccination

  10 weeks counting since first vaccination is initiated.

Secondary Outcomes (1)

• Prevalence of severe adverse reactions

  10 weeks counting since first vaccination is initiated.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

70 patients after allogeneic bone marrow transplant or after CART therapy and 40 patients with a primary immunodeficiency.

You may qualify if:

• Patients aged 18 and over
• Patient sex - male and female
• Bone marrow transplant from a donor (sibling or unrelated) or after cell therapy (CART) at least 3 months before vaccination.
• Patients with primary immunodeficiency syndrome.
• Patients who are able to sign an informed consent form

You may not qualify if:

• Patients under 18 years of age
• Patients who are unable to give informed consent
• Patients with acute GVHD who require steroid therapy above 0.5 mg / kg or who have been diagnosed in the last month.
• Patients with chronic GVHD who require steroid therapy above 0.5 mg / kg
• Patients treated with rituximab / immunoglobulins / mesenchymal cells during the last month.
• Patients whose disease is not completely cured and receive dedicated treatment for the disease.
• Patients receiving maintenance treatment for the underlying disease (excluding TKIs such as sorfenib, midostaurin, guiltritinib or cranolinib).
• Patients who have previously had COVID19.
• Patients with severe allergy to one of the vaccine components.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ron Ram, Prof

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Ram, Prof.

CONTACT

972-3-6973782; ronr@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 26, 2021
• Study Start: December 28, 2020
• Primary Completion: May 28, 2021
• Study Completion: December 28, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

IL (1)