COVID-19 vaccine Antibody response from natural infection or after vaccination in patients with Cystic Fibrosis (CF) MedDRA version: 20.0 Level: LLT Classification code 10021433 Term: Immunization System Organ Class: 100000004865 MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Comirnaty concentrate for dispersion for injection
COVID-19 mRNA Vaccine (nucleoside modified)
Product Name: Comirnaty
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: To
Sponsors
Medical University of Innsbruck, University Clinic for Pediatrics III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consenting people with CF (pwCF) of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population. Are the trial subjects under 18? yes Number of subjects for this age range: 2450 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2525 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: There are no specific exclusion criteria other than refusal to give informed consent, or contraindication to venipuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the following objectives: 1.SARS-CoV-2 seroprevalence in an international CF cohort 2.Examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in people with CF 3.Longitudinal comparison of the development and progression of anti-SARS-CoV-2 antibodies in people with CF following natural infection and vaccination SARS-CoV-2 Optional study objective: Storage of samples for future analysis on the impact of COVID-19 immune response in people with CF ;Primary end point(s): Potential endpoint(s) to include to investigate objective •Proportion of pwCF with at least 1 seropositive result over the 2-year period •Seroprevalence according to age group •Seroprevalence according to geographical area •Seroprevalence according to CF disease genotype and severity. •Change in seroprevalence over time •Risk factors for infection in pwCF •Incidence of symptomatic COVID-19 over the 2 year study period and symptom severity •Proportion of seropositive pwCF with subsequent CF exacerbations compared to pwCF who are seronegative •Morbidity and mortality in pwCF with at least 1 seropositive result compared to pwCF who are seronegative •Levels and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 •Analysis of these samples could include proteomic and genetic analysis and relating this to clinical outcome and antibody data collected as part of main study. ;Timepoint(s) of evaluation of this end point: Analyses will be performed after 12 months and at the study end (24 months). Blood samples will be collected at Day 0 (baseline), and Months 6, 12 and 24 post enrollment.;Secondary Objective: n.a. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a. | — |
Countries
Austria, Canada, European Union, Ireland, United Kingdom, United States
Contacts
Public ContactAss. Prof. Dr. Helmut Elemunter
Medical University of Innsbruck, Paediatrics Department, Cystic Fibrosis Center
Outcome results
None listed