E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hemodialysis patients |
hemodialyse patiënten |
|
E.1.1.1 | Medical condition in easily understood language |
patients with renal failure requiring renal function replacement therapy (i.e. hemodialysis) |
patiënten met nierfalen die niervervangende therapie nodig hebben |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Analysis of side effects and predictive factors for breakthrough infections |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence rate and severity of breakthrough infections |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From day of vaccination until 24 weeks after. |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From day of vaccination until 24 weeks after. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Hemodialysis patients who did no receive a booster vaccine (data from NBVN) |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |