SARS-CoV Infection
Conditions
Keywords
COVID-19, Vaccination
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).
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
Interventions
BIOLOGICALCOMIRNATY - BioNTech Manufacturing GmbH
Vaccination as part of the the Danish national government programme
BIOLOGICALCOVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
Vaccination as part of the the Danish national government programme
BIOLOGICALCOVID-19 Vaccine AstraZeneca suspension for injection
Vaccination as part of the the Danish national government programme
Sponsors
Ministry of the Interior and Health, Denmark
Jens D Lundgren, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent obtained before any trial related procedures are performed 2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan) 3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
Exclusion criteria
1. Male and female under the age of 18 2. Any subgroup of individuals for which the vaccines are contraindicated 3. Previous SARS-CoV-2 vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed