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

Primary Purpose

SARS-CoV Infection

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
COMIRNATY - BioNTech Manufacturing GmbH
COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
COVID-19 Vaccine AstraZeneca suspension for injection
Sponsored by
Jens D Lundgren, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS-CoV Infection focused on measuring COVID-19, Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus Universitetshospital, SkejbyRecruiting
  • Aalborg Universityhospital SydRecruiting
  • Hvidovre HospitalRecruiting
  • Odense UniversityhospitalRecruiting
  • SjællandsuniversitetshospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Vaccine A - COMIRNATY COVID-19 vaccine

Vaccine B - Moderna COVID-19 vaccine

Vaccine C - Astra-Zeneca COVID-19 vaccine

Arm Description

COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528

COVID-19 Vaccine Moderna dispersion for injection (COVID-19, mRNA Vaccine) by MODERNA BIOTECH SPAIN S.L. Marketing Authorisation EU/1/20/1507/001

COVID-19 Vaccine AstraZeneca suspension for injection (ChAdOx1-S [recombinant]) by AstraZeneca AB Marketing Authorisation EU/1/21/1529/001 and /002

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
February 8, 2021
Last Updated
April 11, 2022
Sponsor
Jens D Lundgren, MD
Collaborators
Ministry of the Interior and Health, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04760132
Brief Title
National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)
Acronym
ENFORCE
Official Title
National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens D Lundgren, MD
Collaborators
Ministry of the Interior and Health, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection
Keywords
COVID-19, Vaccination

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccine A - COMIRNATY COVID-19 vaccine
Arm Type
Active Comparator
Arm Description
COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528
Arm Title
Vaccine B - Moderna COVID-19 vaccine
Arm Type
Active Comparator
Arm Description
COVID-19 Vaccine Moderna dispersion for injection (COVID-19, mRNA Vaccine) by MODERNA BIOTECH SPAIN S.L. Marketing Authorisation EU/1/20/1507/001
Arm Title
Vaccine C - Astra-Zeneca COVID-19 vaccine
Arm Type
Active Comparator
Arm Description
COVID-19 Vaccine AstraZeneca suspension for injection (ChAdOx1-S [recombinant]) by AstraZeneca AB Marketing Authorisation EU/1/21/1529/001 and /002
Intervention Type
Biological
Intervention Name(s)
COMIRNATY - BioNTech Manufacturing GmbH
Intervention Description
Vaccination as part of the the Danish national government programme
Intervention Type
Biological
Intervention Name(s)
COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
Intervention Description
Vaccination as part of the the Danish national government programme
Intervention Type
Biological
Intervention Name(s)
COVID-19 Vaccine AstraZeneca suspension for injection
Intervention Description
Vaccination as part of the the Danish national government programme
Primary Outcome Measure Information:
Title
Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines
Description
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 Outcome Measure Information:
Title
Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines
Description
Number of confirmed positive SARS-CoV-2 tests reported via the national testing system.
Time Frame
The change from first vaccination until 24 month
Title
Assessment of the safety of the vaccines will be compared between groups
Description
Reports of participants with local and systemic reactions to the vaccination will be collected
Time Frame
From first vaccine until Day 90
Title
Assessment of any Adverse Event from the vaccines will be compared between groups
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorthe Raben
Phone
+45 3545 5757
Email
dorthe.raben@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte B Nielsen
Phone
+45 3545 5757
Email
charlotte.bjernved.nielsen.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Lundgren, Professor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Østergaard, Professor
Phone
+45 7845 2800
Email
Larsoest@rm.dk
First Name & Middle Initial & Last Name & Degree
Nina B Stærke, MD
Email
NINASE@rm.dk
Facility Name
Aalborg Universityhospital Syd
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Nielsen, MD
Phone
+45 9766 3900
Email
henrik.nielsen@rn.dk
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas L Benfield, Professor
Phone
+45 3862 2302
Email
thomas.lars.benfield@regionh.dk
Facility Name
Odense Universityhospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isik S Johansen, Professor
Phone
45 6541 2652
Email
isik.somuncu.johansen@rsyd.dk
Facility Name
Sjællandsuniversitetshospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lothar Wiese, MD
Phone
+45 4532 3200
Email
low@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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