Clinical trial NCT06360744: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines.
Official title: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines (ENFORCE PLUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: SARS CoV 2 Infection
Keywords: COVID-19
Vaccination
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
First posted: 2024-04-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
Primary purpose: OTHER

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).

Detailed description: 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.

Eligibility 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 'Tilvalgsordningen')
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 vaccine is contra-indicated
3. Previous SARS-CoV-2 vaccination

   Specific for the Johnson \& Johnson vaccine:
4. Experience of a serious allergic reaction after injection of any other vaccine
5. 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
6. Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
7. Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

Primary outcomes:
measure: Assessment of the J& J vaccine
timeFrame: The change from base-line to after 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Aarhus N
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital Syd
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Sjællandsuniversitetshospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens Lundgren, Professor
role: STUDY_CHAIR
References: