Vaccination Against Covid in Primary Immune Deficiencies

Phase 1

• Conditions: 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: 20.0Level: HLTClassification code 10036700Term: Primary immunodeficiency syndromesSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-000515-24-NL
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-05
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified