National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)

Jens D Lundgren, MD7,600 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

7,600

Conditions

SARS-CoV Infection

Interventions

COMIRNATY - BioNTech Manufacturing GmbHBIOLOGICAL

Vaccination as part of the the Danish national government programme

COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECHBIOLOGICAL

Vaccination as part of the the Danish national government programme

COVID-19 Vaccine AstraZeneca suspension for injectionBIOLOGICAL

Vaccination as part of the the Danish national government programme

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Aarhus Universitetshospital, Skejby

Aarhus, Aarhus N, Denmark

Aalborg Universityhospital Syd

Aalborg, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Odense Universityhospital

Odense, Denmark

Outcomes

Primary Outcomes

Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines

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.

Time frame: The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month

Secondary Outcomes

Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines

Number of confirmed positive SARS-CoV-2 tests reported via the national testing system.

Time frame: The change from first vaccination until 24 month

Assessment of the safety of the vaccines will be compared between groups

Reports of participants with local and systemic reactions to the vaccination will be collected

Time frame: From first vaccine until Day 90

Assessment of any Adverse Event from the vaccines will be compared between groups

Reports of participants with grade 3 and 4 Adverse Events and any Serious Adverse will be collected

Time frame: From first vaccine until Day 90

Data from ClinicalTrials.gov

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