Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down syndrome

Phase 4

Recruiting

• Conditions: Down syndroom; Corona vaccination; immune respons; 10027665; 10047438

• Registration Number: NL-OMON54387
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 640

Inclusion Criteria

1. All patients have opted to receive routine COVID-19 vaccination.
2. Age: >=16 years or <16 years if vaccine is recommended for routine use for
that age group
3. Either Down syndrome or healthy household contact

Part 2
- All participants who participated in part 1 of the study and who have opted
to receive a third SARS-CoV-2 vaccination by the studyteam or the Dutch
government.

Additional Durability time point: All individuals already participating in the
PRIDE study are eligble to participate in this additional time point

Exclusion Criteria

Down syndrome cohort: History of severe adverse reaction associated with a
vaccine and/or severe allergic reaction (eg, 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 plus active care for
inherited or acquired immune deficiency, any moderate to severe comorbidity for
which regular medical care is needed (pe heart failure, COPD, diabetes).

Part 2
Anaphylactic reaction to previous COVID-19 vaccination

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified