SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial

MEC-2022-0462

Eighty percent of the Dutch population has completed a primary COVID-19 vaccination regimen, and 60% of the population received a booster vaccination. Waning immunity, combined with the emergence of antigenically distinct SARS-CoV-2 variants, has led to the consideration of additional booster vaccinations in the Dutch population by autumn 2022. However, despite efforts of the Dutch policymakers, the public's willingness to repeatedly receive COVID-19 booster vaccinations is declining. This is mainly due to a reduced burden of disease by COVID-19, fewer hospitalizations, and fewer deaths. However, population immunity might be one of the major factors responsible for this reduced burden of disease, possibly emphasizing the need for booster vaccinations. In this proposal we will address an important question asked by policymakers: "Are booster vaccinations in autumn recommended for the healthy population?"

2022-08-20

2022-09-15

2023-08-30

Active (not recruiting)

431

Inclusion Criteria: 1. Participant is willing and able to give written informed consent for participation in the trial. 2. Adult (male/female) between 18 and 65 years old 3. Sufficient level of the Dutch language to undertake all study requirements Exclusion Criteria: 1. Adults younger than 18 or older than 65 years. 2. Adults primed with another vaccine than Janssen, Moderna or Pfizer. 3. History of allergic reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed ingredients of the Janssen/Pfizer/Moderna vaccine). 4. Adults that are pregnant. 5. Currently being treated for cancer. 6. Severe kidney failure or dialyses dependent. 7. Status after organ-, stem cell- or bone marrow transplantation. 8. Use of immunosuppressant's. 9. Epilepsy. 10. HIV. 11. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following IM injections of vene puncture. 12. Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc). 13. Participants who are currently participating in another research trial. 14. All regular contra-indications of the vaccines will be applied.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A multicenter, randomized, controlled trial comparing immune responses 7 and 28 days after an additional COVID-19 booster vaccination between Janssen and mRNA primed HCWs to describe the immune response in a cohort representative of the Dutch population, in order to eventually provide data for Dutch policy makers', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 431, 'type': 'ACTUAL'}}

2023-02-15