Primary Immune Deficiencies
Conditions
Interventions
Study participants will receive the COVID-19 Vaccine Moderna ccording to
manufacturer's protocol, which requires two injections of 0.5 mL each, by
intramuscular injection, with interval of 28 days
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subjects must meet the Inclusion Criteria for enrollment into the study. 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)
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 (e.g., anaphylaxis) to any component of the study intervention(s). Women who are pregnant or breastfeeding Active (hematological) 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 |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. Evaluation of the antibody and cellular response in a group of subjects that receive a 3rd SARS-CoV-2 vaccination, not part of this protocol, by the Municipal Public Health Services (GGDs), at day 28-42 after 3rd vaccination. | — |
Countries
Netherlands
Outcome results
None listed