A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines.

NCT06360744 | Completed Phase 4

• 1 other identifier: ENFORCE PLUS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines. The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme. 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).

Conditions

SARS CoV 2 Infection

Keywords

COVID-19; Vaccination

Outcome Measures

Primary Outcomes (1)

• Assessment of the J& J vaccine

  To clarify whether vaccination with the J\&J vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the J\&J vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies compared to mRNA vaccines. Included is also questionnaires

  The change from base-line to after 24 month

Study Arms (1)

Vaccine Johnson and Johnson/Janssen Covid-19 vaccine

OTHER

Johnson \& Johnson/Janssen Covid-19 vaccine.

Biological: Johnson & Johnson

Interventions

Johnson & Johnson BIOLOGICAL

Vaccination with the Johnson \& Johnson vaccine which is NOT part of the Danish National Government programme

Vaccine Johnson and Johnson/Janssen Covid-19 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 'Tilvalgsordningen')
• The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

You may not qualify if:

• Male and female under the age of 18
• Any subgroup of individuals for which the vaccine is contra-indicated
• Previous SARS-CoV-2 vaccination
• Specific for the Johnson \& Johnson vaccine:
• Experience of a serious allergic reaction after injection of any other vaccine
• Serious infection with high fever (\> 38 0C) A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
• Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
• Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

Sponsors & Collaborators

• Jens D Lundgren, MD: lead
• Ministry of the Interior and Health, Denmark: collaborator

Study Sites (5)

Aarhus Universitetshospital, Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

Aalborg Universitetshospital Syd

Aalborg, 8000, Denmark

Location

Hvidovre Hospital

Hvidovre, 2600, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Sjællandsuniversitetshospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jens Lundgren, Professor

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: April 11, 2024
• Study Start: July 5, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)