Persons with Down syndrome
Conditions
Interventions
Trade Name: Comirnaty
COVID-19 mRNA Vaccine (nucleoside modified)
Pharmaceutical Form: Concentrate for dispersion for injection
Trade Name: COVID-19 Vaccine Moderna
Pharmaceutical Form: Dispersion fo
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - durability of the antibody response - SARS-CoV-2-specific T and B cell response - adverse events -Mucosal antibody response and correlation with the antibody response in serum ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Longevity of SARS-CoV-2 specific antibodies 12 months after the second vaccination will be compared between cohorts. • 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). • 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. ;Timepoint(s) of evaluation of this end point: 28 days after the first and second COVID-19 vaccination 12 months after the second COVID-19 vaccination | — |
Countries
Netherlands
Contacts
Public ContactPRIDE study
University Medical Center Utrecht
Outcome results
None listed