Down syndroom Corona vaccination immune respons
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
No minimum to 99 Years
Inclusion criteria
Inclusion criteria: 1. All patients have opted to receive routine COVID-19 vaccination. 2. Age: >=16 years or
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the serum concentration of SARS-CoV-2-specific antibodies (against the spike protein) at t=3 (on day 28 after the second vaccination) as measured by the multiplex immune assay (MIA) by the National Institute for Public Health and the Environment (RIVM). Participants will be classified as responders or non-responders. The definition of response will be based on the latest available data from the pivotal studies and will be defined prior to data analyses and the first database lock. We will inform the IRB about this definition and add this information to ClinicalTrials.gov. The percentage of responders in the Down Syndrome versus the healthy controls will be compared. Part 2 The primary endpoint of the second part of the study is the serum concentration of SARS-CoV-2-specific antibodies (against the spike protein) at t=5 (on day 28 after the third vaccination) as measured by the multiplex immune assay (MIA) by the National Institute for Public Health and the Environment (RIVM). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: - longevity of the immune response at 6 months after the last vaccination and 1 to 1,5 years after the intitial vaccination series. - mucosal antibody response at 28 days and 6 months after second vaccination and 1 to 1,5 years after the intitial vaccination series. - adverse events and - levels of SARS-CoV-2 specific T and B cell responses and their durability 1 to 1,5 years after the intitial vaccination series Other parameters: - the association between baseline (immune) parameters and the immune response to SARS-CoV-2 vaccination - the neutralizing capacity of anti-COVID-19 antibodies against ancestral SARS-CoV-2 and novel variants - the incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 12 months after SARS-CoV-2 vaccination. Part 2 The secondary endpoints of the second part of the study include - mucosal antibody response at 28 days, 6 months after the 1st booster vaccination (=3rd vaccination) - adverse events and - levels of SARS-CoV-2 specific T and B cell responses (subset of participants) | — |
Countries
Netherlands
Outcome results
None listed