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 ascompare whether the vaccine is causing a greater activation of platelets and anti-PF4than the mRNA vaccines.The Danish Medicines Agency has approved the vaccine from J&J for use in Denmark, howeverit is not currently part of the national vaccine programme.The design is an open-labelled, non-randomised, parallel group, phase IV study withhistorical controls. A sub-study will be embedded within this master protocol addressingbasic and translational research questions requiring additional sampling of biologicalmaterial (under separate participant informed consent).
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.
Biological: Johnson & Johnson
Vaccination with the Johnson & Johnson vaccine which is NOT part of the Danish National
Government programme
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)
Aarhus Universitetshospital, Skejby
Aarhus 2624652, Aarhus N, Denmark
Aalborg Universitetshospital Syd
Aalborg 2624886, Denmark
Hvidovre Hospital
Hvidovre 2619528, Denmark
Odense Universitetshospital
Odense 2615876, Denmark
Sjællandsuniversitetshospital
Roskilde 2614481, Denmark
Jens Lundgren, Professor, Study Chair
Rigshospitalet, Denmark