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

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).

Full Title of Study: “National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

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

  • Biological: COMIRNATY – BioNTech Manufacturing GmbH
    • Vaccination as part of the the Danish national government programme
  • Biological: COVID-19 Vaccine Moderna dispersion for injection – MODERNA BIOTECH
    • Vaccination as part of the the Danish national government programme
  • Biological: COVID-19 Vaccine AstraZeneca suspension for injection
    • Vaccination as part of the the Danish national government programme

Arms, Groups and Cohorts

  • Active Comparator: Vaccine A – COMIRNATY COVID-19 vaccine
    • COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines
    • Time Frame: 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 Measures

  • Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: From first vaccine until Day 90
    • Reports of participants with grade 3 and 4 Adverse Events and any Serious Adverse will be collected

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jens D Lundgren, MD
  • Collaborator
    • Ministry of the Interior and Health, Denmark
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jens D Lundgren, MD, Professor – Rigshospitalet, Denmark
  • Overall Official(s)
    • Jens Lundgren, Professor, Study Chair, Rigshospitalet, Denmark
  • Overall Contact(s)
    • Dorthe Raben, +45 3545 5757, dorthe.raben@regionh.dk

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