Primary Immunodeficiency Clinical Trial
Official title:
Efficacy and Safety of COVID-19 Vaccine in Patients After Allogeneic Hamatopoietic Cell Transplantation, CAR-T Therapy and With Primary Immune Deficiency - a Post Marketing Prospective Cohort Study
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.
The study population will be allogeneic bone marrow transplant patients and those who have received CART therapy - immunocompromised patients who are vaccinated with COVID-19 in a commercial preparation, regardless of the study. The following procedures are routinely performed before receiving the vaccine in the bone marrow transplant unit - 1. Blood count and lymphocyte subgroup counts before vaccination (up to 48 hours before vaccination). 2. Evaluation of GVHD activity and accompanying toxicity. 3. Receipt of a letter confirming the vaccination to the HMO. 4. One-week follow-up after vaccination including blood count, complete chemistry, GVHD evaluation, and review of adverse reactions that may be vaccine-related. 5. Referral for a second dose of the vaccine. 6. One week follow-up after vaccination including blood count, complete chemistry, GVHD evaluation, review of side effects that may be vaccine related. The following procedures are performed only as part of the study - 1. Serology test (IgG AntiS) two weeks after the second dose of the vaccine to test the effectiveness of the vaccine. Cell separation two weeks after the second vaccination and execution - 2. ELISpot test to test for the release of interferon gamma in response to the stimulation of cells separated with the SARS-COV-2 virus peptides (stimulation with S peptides to evaluate vaccine response, and stimulation with M peptides as a control). All data collected in the study will be typed into Excel and analyzed using SPSS version 25.0. Continuous data will be described using averages and standard deviations, and categorical data will be described using prevalence and percentages. The distribution of the continuous variables will be presented using an outline graph and will be examined using the Kolmogorov Smirnov test. An attempt will be made to perform subgroup analysis (depending on the frequency of the groups in the sample) for the patient group: Patients after bone marrow transplantation with acute GVHD Patients after bone marrow transplantation with chronic GVHD Patients after bone marrow transplantation without immunosuppressive therapy Patients after Cell Therapy (CART) Patients lack primary immunization ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04561115 -
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
|
Phase 3 | |
| Recruiting |
NCT06355323 -
Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
|
N/A | |
| Completed |
NCT04566692 -
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
|
Phase 4 | |
| Completed |
NCT01465958 -
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency
|
Phase 4 | |
| Completed |
NCT01581593 -
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
|
Phase 3 | |
| Completed |
NCT02881437 -
IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
|
Phase 4 | |
| Recruiting |
NCT06092528 -
Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency
|
N/A | |
| Active, not recruiting |
NCT03576742 -
Severe Immune Cytopenia Registry Www.Sic-reg.Org
|
||
| Completed |
NCT03907241 -
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
|
Phase 3 | |
| Not yet recruiting |
NCT04902807 -
Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
|
||
| Completed |
NCT02806986 -
Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency
|
Phase 3 | |
| Completed |
NCT03339778 -
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
|
N/A | |
| Enrolling by invitation |
NCT00895271 -
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
|
||
| Recruiting |
NCT03206099 -
NIAID Centralized Sequencing Protocol
|
||
| Completed |
NCT02503293 -
A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push
|
Phase 4 | |
| Recruiting |
NCT03610802 -
Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies
|
||
| Completed |
NCT03815357 -
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
|
||
| Completed |
NCT02269163 -
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
|
Phase 3 | |
| Terminated |
NCT03733249 -
Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT02123615 -
ASIS for GAMMAGARD in Primary Immunodeficiency
|
Phase 1/Phase 2 |