Vaccination Against Covid in Primary Immune Deficiencies

Recruiting

Conditions: Primary Immune Deficiencies
inborn errors of immunity
10021460

Registration Number: NL-OMON52126

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 700

Inclusion Criteria

Subjects must meet the Inclusion Criteria for enrollment into the study.

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the antibody response in patients with an isolated<br /><br>antibody deficiency (selective IgG subclass deficiency or SADNI) on day 28<br /><br>after vaccination</p><br>

Secondary Outcome Measures