Vaccination Against Covid in Primary Immune Deficiencies - VACOPID

Erasmus University Medical Center0 个研究点目标入组 700 人开始时间: 2021年2月5日最近更新: 2021年4月5日

试验速览

暂无简介。

•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
•- Selective IgG subclass deficiency
•- 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

•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.

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