COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000515-24/NL

Erasmus University Medical Center - Prof.dr. R.P. Peeters

r.peeters@erasmusmc.nl

2021-02-05

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

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) Een van onderstaande diagnoses: CVID, met of zonder gebruik van afweeronderdrukkende medicatie immuunsuppresiva CID CGD XLA Selectieve IgG subklasse deficiëntie SADNI 18 jaar of ouder. In staat toestemming te geven

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. Kwaadaardige ziekte die op dit moment onvolledig genezen is HIV (Humaan Immunodeficiency Virus) Zwanger of borstvoeding gevend Eerdere ernstige allergische reactie op een vaccin Aandoening waarbij een hoger bloedingsrisico bestaat, waardoor een injectie in de spieren kan leiden tot complicaties

1

Erasmus University Medical Center

18

100

Netherlands

High risk patients

N/A

700

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 Primair eindpunt is de antistof respons in patiënten met een geïsoleerde antistof deficiëntie (selectieve IgG subklasse deficiëntie of selectieve antistof deficiëntie met normale immuunglobulinen) op dag 28 na vaccinatie

nan

Phase 4

[{"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]