Effectivity of COVID-19 vaccination in people with Down syndrome

Phase 1

• Conditions: Persons with Down syndrome; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-002613-34-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

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

Exclusion Criteria

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
Plus
•Active medical care for inherited or acquired immune deficiency
•Any severe comorbidity for which regular medical care is needed (e.g. heart failure, COPD, diabetes)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antibody response after mRNA (Pfizer/Biontech, Moderna) and viral vector-based (AstraZeneca) SARS-CoV-2 vaccination in people =16 years and children with Down syndrome;Secondary Objective: To assess in adults and children with DS after SARS-CoV 2 vaccination:<br>- durability of the antibody response<br>- SARS-CoV-2-specific T and B cell response<br>- adverse events<br>-Mucosal antibody response and correlation with the antibody response in serum<br>;Primary end point(s): The primary study parameter is the antibody based immune response to vaccination against COVID-19 28 days after the second vaccination as compared to controls. ;Timepoint(s) of evaluation of this end point: 28 days after second vaccination with a COVID-19 vaccine

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Longevity of SARS-CoV-2 specific antibodies 12 months after the second vaccination will be compared between cohorts. <br>•SARS-CoV2 specific T cell response will be measured at baseline, at 21-28 days after the first vaccination and at 28 days after the second vaccination and expressed as the number of IFN-? producing SARS-CoV2 specific T cells/million PBMC (mean of 3 measures). <br>•Mucosal SARS-CoV-2 specific antibodies will be measured 28 days and 12 months after the second vaccination. Antibody titers will be compared between cohorts and with antibody titers in blood. <br>;Timepoint(s) of evaluation of this end point: 28 days after the first and second COVID-19 vaccination<br>12 months after the second COVID-19 vaccination