The primary objective of the study is to assess if the SARS-CoV-2 vaccine Johnson & Johnson/Janssen results in change in number and activation of platelets and anti-PF4 level. As well as to compare whether the Johnson & Johnson/Janssen vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines. The Danish Medicines Agency has approved the vaccine from Johnson & Johnson/Janssen for use in Denmark, however it is not currently part of the national vaccine programme. M
Conditions
Interventions
Trade Name: COVID-19 Vaccine Janssen suspension for injection
COVID-19 vaccine(AD26.CoV2-S [recombinant])
Product Name: COVID-19 Vaccine Janssen
Pharmaceutical Form: Suspension for injection
INN or Pr
Sponsors
CHIP - Rigshospitalet - University of Copenhagen
Eligibility
Sex/Gender
All
Inclusion 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 national vaccination plan/Tilvalgsordningen) 3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Male and female under the age of 18 2. Any subgroup of individuals for which the vaccines are 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to clarify whether vaccination with the Johnson & Johnson/Janssen vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the Johnson & Johnson/Janssen vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies than mRNA vaccines;Secondary Objective: The secondary objectives are changes in the following biomarkers: •Platelet count, D-dimer, fibrinogen (lab. VITT) •Platelet activity: TGFß, P-selectin •Possibly thrombus generation •Vascular and immunological markers ;Primary end point(s): The primary endpoint is the change in the level of anti-PF4-antibodies from pre- to post vaccination. ;Timepoint(s) of evaluation of this end point: MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24. The exact value of the MPNAT is currently not precisely defined, but is expected to be documented within short periods of time based on analyses across the ongoing phase III trials, associating titre levels with risk of breakthrough infection in the actively vaccinated group. As the exact value of the MPNAT remains to be determined, and until that time point has arisen, a priori (i.e. while remaining blinded to the actually obtained data) of the actually defined cut-offs in neutralising titres that reasonable can serve as proxy for the MPNAT will be recommended by an expert advisory panel, and endorsed by the study leadership | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See under objectives;Timepoint(s) of evaluation of this end point: As above | — |
Countries
Denmark
Contacts
Public ContactJens Lundgren
CHIP - Rigshospitalet, University of Copenhagen
Outcome results
None listed