NCT05145348|Unknown
Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome.
PRIDE
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PRIDE
Sponsor study identifier
observational
640
1 country
1
Study Start
February 3, 2021
Actual (reported)Primary Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The risk of severe course of SARS-CoV-2 infection in people with Down Syndrome is substantially increased. The risk of death is 3-10 fold higher than in healthy people. SARS-CoV-2 vaccines have been registered for adults and adolescents but none of them have been studied in people with Down Syndrome. Vaccine responses in people with Down Syndrome are known to be suboptimal. Therefor the objective of this study is to assess the immunogenicity of SARS-CoV-2 vaccination in people with Down syndrome. To do so, the antibody response, cellulair and mucosal immuneresponse in people with Down syndrome after the SARS-CoV-2 vaccination will be evaluated and compared to healthy controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2021
Actual (reported)December 3, 2021
Actual (reported)December 6, 2021
Actual (reported)June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Antibody based immune response to vaccination against COVID-19 28 days (t=3) after the second vaccination as compared to controls.
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. The percentage of responders in the DS cohort will be compared with the percentage responders in the HS cohort.
28 days after the second vaccination
Longevity of SARS-CoV-2 specific antibodies
1 year after the second vaccination
SARS-CoV2 specific T cell response
Number of T cells will be measured at baseline, at 21-28 days after the first vaccination and at 28 days after the second vaccination
Mucosal SARS-CoV-2 specific antibodies
Mucosal antibodies will be measured 28 days and 12 months after the second vaccination.
Determination of fucosylation, sialylation, galactosylation and bisection of IgG in patients with a history of COVID-19.
All time points
Age-specific T-cell immunophenotyping
All time points
Neutralizing capacity of SARS-CoV-2 antibodies
Measurements at baseline, 21-28 days after first vaccination and 28 days, and 12 months after second vaccination.
Adults and adolescents with Down syndrome \>16 years old.
Healthy adults and adolescents without Down syndrome \> 16 years old. Without any significant comorbidities.
Children with Down syndrome \< 16 years old.
Healthy children without Down syndrome \< 16 years old. Without any significant comorbidities.
The vaccination is not part of the study, but part of the national immunization programme of the Netherlands. Blood will be drawn at 4 time points: baseline (t=1, \<2 months prior to first vaccination); t=2: 21-28 days after first vaccination and prior to second vaccination; t=3: 28 (21-42) days after second vaccination; t=4: 12 months (+/- 1 month) after second vaccination. Mucosal Lining Fluid (MLF) samples will be collected at 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Down syndrome: The patient population will either live in institutions or outside these facilitys depending on the cognitive functions and additional care needed. Children will mostly live with their parents. All participants will live in the Netherlands Healthy control: All healthy control participants will live in the Netherlands, no specific region.
UMC utrecht
Utrecht, 3584 CX, Netherlands
Hensen LCM, Streng BMM, van Wijk F, Nierkens S, Wildenbeest JG, Bont LJ, Delemarre EM; PRIDE study group. T-cell responses to primary SARS-CoV-2 vaccination in Down syndrome - From childhood to adulthood. Hum Vaccin Immunother. 2026 Dec 31;22(1):2670839. doi: 10.1080/21645515.2026.2670839. Epub 2026 Jun 1.
Streng BMM, Hensen LCM, Delemarre EM, Binnendijk RS, Smits G, den Hartog G, van der Klis FR, de Vries E, Burger JA, van Gils MJ, Coppus AMW, Weijerman ME, Lamberts R, de Graaf G, Bont LJ, Wildenbeest JG. Antibody concentration and function following SARS-CoV-2 vaccination decrease with age in adults and children with Down syndrome. Vaccine. 2026 Feb 15;73:128079. doi: 10.1016/j.vaccine.2025.128079. Epub 2025 Dec 24.
Serum, Whole blood, PBMC's, mucosal nose swab
Louis J Bont, MD, PhD
UMC Utrecht
First Submitted
December 3, 2021
First Posted
December 6, 2021
Study Start
February 3, 2021
Actual (reported)Primary Completion
June 30, 2022
Estimated (date passed)Adaptive Immune Response to COVID-19 Vaccination
Contact the study team to confirm eligibility.
Hensen LCM, Streng BMM, van Wijk F, Nierkens S, van Binnendijk RS, Buisman AM, Coppus AMW, Geurts van Kessel CH, de Graaf G, van der Klis FR, Lamberts R, Vidarsson G, Ruckwardt TJ, de Vries E, de Vries RD, Weijerman ME, Weinberger DM, Wildenbeest JG, Bont LJ, Delemarre EM. T-cell responses to SARS-CoV-2 vaccinations in adults with Down syndrome - a prospective cohort study. Hum Vaccin Immunother. 2025 Dec;21(1):2583416. doi: 10.1080/21645515.2025.2583416. Epub 2025 Nov 6.
Streng BMM, Bont M, Delemarre EM, Binnendijk RS, Smit G, den Hartog G, Coppus AMW, de Vries E, Weijerman ME, Lamberts R, de Graaf G, van der Klis FR, Vidarsson G, Rave N, Bont LJ, Wildenbeest JG. Decreased Antibody Response After Severe Acute Respiratory Syndrome Coronavirus 2 Vaccination in Patients With Down Syndrome. J Infect Dis. 2022 Sep 4;226(4):673-677. doi: 10.1093/infdis/jiac235.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 30, 2021
Record last verified: 2021-12
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