Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down Syndrome - PRIDE study

niversity Medical Center Utrecht0 sites640 target enrollmentJune 11, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects are eligible for the study if all of the following apply:
•Willing to receive routine COVID\-19 vaccination with Pfizer, Moderna or AstraZeneca vaccine.
•Age: \=16 years or \<16 years once vaccine is recommended for routine use in this age group
•Either Down syndrome or household contacts without Down syndrome of participant with Down syndrome
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 260
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 340
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 40

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Down syndrome cohort
•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).
•Organ transplant recipients
•Active malignancy or completion of treatment for malignancy in previous 3 months
•Infection with Human Immunodeficiency Virus (HIV)
•Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
•Healthy control cohort
•As in Down Syndrome cohort
•Active medical care for inherited or acquired immune deficiency