hemodialysis patients
Conditions
Interventions
Trade Name: Spikevax (Moderna)
Product Code: J07BX03
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: NAP
CAS Number: 2430046-03-8
Current Sponsor code: mRN
Sponsors
AZ Sint-Jan Brugge-Oostende AV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A consecutive series of hemodialysis patients which received 2 doses of a mRNA vaccine against Covid-19 and are willing to participate to the trial. Patients are eligible for inclusion 6 months after receiving the first dose. A target of around 800 patients is envisioned. Participants will be recruited in 5 participating centers (AZ Sint-Jan, AZ Damiaan, ZOL, OLV Aalst and AZ Groeninghe). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: i. Younger than 18 years old ii. No informed consent iii. No previous vaccination with two mRNA Covid-19 vaccines, according to the scheme mentioned in the SmPC. iv. Individuals who are suffering from acute severe febrile illness or acute infection. People with a minor infection and/or low-grade fever should not be excluded. (This exclusion criteria is based on the SmPC of Comirnaty and COVID-19 vaccine Moderna, however, vaccination will be performed according to standard medical practice and at the discretion of the treating physician). v. Subjects with a history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study intervention (This exclusion criteria is based on the SmPC of COVID-19 vaccine Moderna, however, vaccination will be performed according to standard medical practice and at the discretion of the treating physician). vi. Unable to provide informed consent or not competent to understand the informed consent procedure and no legal representative vii. Not eligible to abovementioned inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to determine the rate of breakthrough infections in a population of hemodialysis patients which will receive a third vaccination against Covid-19 with the mRNA-1273 Covid-19 vaccine 6 months after the first vaccine and compare this with a control population. To this end, the figures of the ‘Nederlandstalige Belgische Vereniging voor Nefrologie’ (NBVN) registration will be used, which monitors the Covid-19 infections of all hemodialysis patients in the Flemish region.;Secondary Objective: Analysis of side effects and predictive factors for breakthrough infections;Primary end point(s): Incidence rate and severity of breakthrough infections;Timepoint(s) of evaluation of this end point: From day of vaccination until 24 weeks after. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Analysis of baseline clinical predictive factors for breakthrough infections in hemodialysis patients 2. Analysis of adverse events 3. Analysis of variants of concern;Timepoint(s) of evaluation of this end point: From day of vaccination until 24 weeks after. | — |
Countries
Belgium
Contacts
Public ContactCTC
Clinical Trial Center
Outcome results
None listed