Patients with primary immunodeficiency disease, also known as inborn errors pf immunity, are vaccinated against COVID-19 using COVID-19 Vaccine Moderna. The vaccine has been approved for use in the Netherlands and all adults in the Netherlands are vaccinated according the the National Vaccination Campaign that started in January 2021 MedDRA version: 20.0 Level: HLT Classification code 10036700 Term: Primary immunodeficiency syndromes System Organ Class: 100000004870
Conditions
Interventions
Trade Name: COVID-19 Vaccine Moderna
Pharmaceutical Form: Dispersion for injection
Sponsors
Erasmus University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible for the study if all of the following apply: 1. All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer. 2. Age of 18 years or older 3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) 4. A diagnosis of either one of the IUIS criteria based diagnoses below: - CVID, with or without use of immunosuppressive therapy - CID - CGD - XLA - Selective IgG subclass deficiency - SADNI - Partners, sibling or other family member from patient (not suffering from a PID) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). Women who are pregnant or breastfeeding Active (haematological) malignancy HIV (Human Immunodeficiency Virus) Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Patients will receive two vacinations, according tomanufacturer's protocol, with an interval of 28 days. Primary endpoint will be evaluated at day 28 after second vaccination.;Main Objective: To assess immunogenicity and safety of SARS-CoV-2 vaccination in patients with isolated antibody deficiencies, i.e. patients with immunoglobulin G (IgG) subclass deficiency and patients with selective antibody deficiency with normal immunoglobulins (SADNI), which are clinically characterized by an increased risk of infections. To explore immunogenicity and safety of SARS-CoV-2 vaccination in patients with Common Variable Immune Deficiency (CVID), Combined Immunodeficiency (CID), Chronic Granulomatous Disease (CGD) and X-linked agammaglobulinemia (XLA), which are clinically characterized by an increased risk of infections and immune dysregulation The primary endpoint is the antibody response in patients with an isolated antibody deficiency (selective IgG subclass deficiency or SADNI) on day 28 after vaccination;Secondary Objective: Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity. Other secondary endpoints include monitoring of occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses. Evaluation of the antibody response in patients with CVID, CID, CGD or XLA on day 28 after vaccination will be a secondary endpoint of this study. Other secondary endpoints for patients with CVID, CID, CGD or XLA include safety, occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary endpints wil be determined after 6 months and 12 months of start study;Secondary end point(s): Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity. Other secondary endpoints include monitoring of occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses. Evaluation of the antibody response in patients with CVID, CID, CGD or XLA on day 28 after vaccination will be a secondary endpoint of this study. Other secondary endpoints for patients with CVID, CID, CGD or XLA include safety, occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses | — |
Countries
Netherlands
Contacts
Public ContactProf.dr. R.P. Peeters
Erasmus University Medical Center
Outcome results
None listed