National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)
Study Details
Study Description
Brief Summary
National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU, and which are being offered at participating units.
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
First phase will enrol 10,000 persons initiating vaccination (assuming 4 vaccines). If more vaccines become available additional 2,500 persons per vaccine will be included. Subsequent phases with larger sections of the population included may be implemented.
Participants will have 6 study visits and be followed for 2 years after the first vaccination, which offers the participants an extra close follow up on vaccine effectiveness. Safety data will be collected at study visits until 3 months after the first vaccination. Research samples will be collected at each study visit during the two year follow-up
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Vaccine A - COMIRNATY COVID-19 vaccine COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528 |
Biological: COMIRNATY - BioNTech Manufacturing GmbH
Vaccination as part of the the Danish national government programme
|
| Active Comparator: Vaccine B - Moderna COVID-19 vaccine COVID-19 Vaccine Moderna dispersion for injection (COVID-19, mRNA Vaccine) by MODERNA BIOTECH SPAIN S.L. Marketing Authorisation EU/1/20/1507/001 |
Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
Vaccination as part of the the Danish national government programme
|
| Active Comparator: Vaccine C - Astra-Zeneca COVID-19 vaccine COVID-19 Vaccine AstraZeneca suspension for injection (ChAdOx1-S [recombinant]) by AstraZeneca AB Marketing Authorisation EU/1/21/1529/001 and /002 |
Biological: COVID-19 Vaccine AstraZeneca suspension for injection
Vaccination as part of the the Danish national government programme
|
Outcome Measures
Primary Outcome Measures
- Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines [The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month]
Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.
Secondary Outcome Measures
- Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines [The change from first vaccination until 24 month]
Number of confirmed positive SARS-CoV-2 tests reported via the national testing system.
- Assessment of the safety of the vaccines will be compared between groups [From first vaccine until Day 90]
Reports of participants with local and systemic reactions to the vaccination will be collected
- Assessment of any Adverse Event from the vaccines will be compared between groups [From first vaccine until Day 90]
Reports of participants with grade 3 and 4 Adverse Events and any Serious Adverse will be collected
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent obtained before any trial related procedures are performed
-
Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
-
The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
Exclusion Criteria:
-
Male and female under the age of 18
-
Any subgroup of individuals for which the vaccines are contraindicated
-
Previous SARS-CoV-2 vaccination
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus Universitetshospital, Skejby | Aarhus | Aarhus N | Denmark | 8200 |
| 2 | Aalborg Universityhospital Syd | Aalborg | Denmark | 9000 | |
| 3 | Hvidovre Hospital | Hvidovre | Denmark | 2600 | |
| 4 | Odense Universityhospital | Odense | Denmark | 5000 | |
| 5 | Sjællandsuniversitetshospital | Roskilde | Denmark | 4000 |
Sponsors and Collaborators
- Jens D Lundgren, MD
- Ministry of the Interior and Health, Denmark
Investigators
- Study Chair: Jens Lundgren, Professor, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENFORCE