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Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome.

NCT05145348 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 640

Last updated 2021-12-30

No results posted yet for this study

Summary

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.

Conditions

  • Down Syndrome
  • SARS-CoV-2 Vaccination

Interventions

BIOLOGICAL

Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • National Institute for Public Health and the Environment (RIVM)

    collaborator OTHER_GOV

  • Stichting Downsyndroom (SDS)

    collaborator UNKNOWN

  • Sanquin Research & Blood Bank Divisions

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Louis J Bont, MD, PhD · UMC Utrecht

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145348 on ClinicalTrials.gov