A Phase 4 interventional study of Johnson & Johnson in SARS CoV 2 Infection, sponsored by Jens D Lundgren, MD. Completed at 5 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Jens D Lundgren, MD · Phase 4, Interventional, and Other
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).
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 25 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Jens D Lundgren, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Previous SARS-CoV-2 vaccination
Specific for the Johnson \& Johnson vaccine:
Johnson \& Johnson/Janssen Covid-19 vaccine.
Biological: Johnson & Johnson
Vaccination with the Johnson \& Johnson vaccine which is NOT part of the Danish National Government programme
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
Time frame: The change from base-line to after 24 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Jens D Lundgren, MD