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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760132
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : April 12, 2022
Sponsor:
Collaborator:
Ministry of the Interior and Health, Denmark
Information provided by (Responsible Party):
Jens D Lundgren, MD, Rigshospitalet, Denmark

Study Description
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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
SARS-CoV Infection Biological: COMIRNATY - BioNTech Manufacturing GmbH Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH Biological: COVID-19 Vaccine AstraZeneca suspension for injection 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760132


Contacts
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Contact: Dorthe Raben +45 3545 5757 dorthe.raben@regionh.dk
Contact: Charlotte B Nielsen +45 3545 5757 charlotte.bjernved.nielsen.01@regionh.dk

Locations
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Denmark
Aarhus Universitetshospital, Skejby Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Lars Østergaard, Professor    +45 7845 2800    Larsoest@rm.dk   
Contact: Nina B Stærke, MD       NINASE@rm.dk   
Aalborg Universityhospital Syd Recruiting
Aalborg, Denmark, 9000
Contact: Henrik Nielsen, MD    +45 9766 3900    henrik.nielsen@rn.dk   
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2600
Contact: Thomas L Benfield, Professor    +45 3862 2302    thomas.lars.benfield@regionh.dk   
Odense Universityhospital Recruiting
Odense, Denmark, 5000
Contact: Isik S Johansen, Professor    45 6541 2652    isik.somuncu.johansen@rsyd.dk   
Sjællandsuniversitetshospital Recruiting
Roskilde, Denmark, 4000
Contact: Lothar Wiese, MD    +45 4532 3200    low@regionsjaelland.dk   
Sponsors and Collaborators
Jens D Lundgren, MD
Ministry of the Interior and Health, Denmark
Investigators
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Study Chair: Jens Lundgren, Professor Rigshospitalet, Denmark
More Information
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Responsible Party: Jens D Lundgren, MD, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04760132    
Other Study ID Numbers: ENFORCE
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jens D Lundgren, MD, Rigshospitalet, Denmark:
COVID-19
Vaccination
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs