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

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).

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Key information

Conditions

SARS CoV 2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus Universitetshospital, Skejby, Aarhus, Aarhus N, Denmark

About this study

Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. In this way the participants will be offered an extra close follow up on vaccine effectiveness.

Safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination.

Research samples will be collected at each study visit during the two-year follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 'Tilvalgsordningen')
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 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)

Treatment and study plan

Johnson & Johnson

Biological

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

Primary outcomes

Assessment of the J& J vaccine

Time frame: The change from base-line to after 24 month

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

Sponsors and collaborators

Lead sponsor

Jens D Lundgren, MD

Other

Collaborators

Ministry of the Interior and Health, Denmark

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 11, 2024
Registry last updated: Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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