Clinical trial NCT05471440: SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in HCW
Official title: SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid-19 Vaccination
Keywords: Covid-19
Boost
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Leiden University Medical Center
name: University Medical Center Groningen
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2022-07-22
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

Brief summary: 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?"


Eligibility criteria: 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.

Primary outcomes:
measure: Is there an increase in antibody levels between day of boost and 28 days after boosting HCW that were initially primed with either the Janssen or an mRNA-based vaccine?
timeFrame: 28 days
measure: Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?
timeFrame: 28 days
Secondary outcomes:
measure: What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?
timeFrame: 28 days
measure: What is the breadth of the immune responses after booster vaccination?
timeFrame: 28 days
measure: What is the predictive value of immune responses on day 7 post boost?
timeFrame: 28 days
measure: What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?
timeFrame: 7 days
measure: Initial examination of breakthrough infections before and during study period
timeFrame: 1 year
Other outcomes:
measure: Gene expression profiles associated with recall response (PAXgene tube)
timeFrame: 28 days
measure: SARS-CoV-2-specific T-cell responses
timeFrame: 28 days
Locations:
city: Amsterdam
country: Netherlands
facility: AmsterdamUMC
city: Groningen
country: Netherlands
facility: UMCG
city: Leiden
country: Netherlands
facility: LUMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus MC, Rotterdam
name: Hugo van der Kuy, PharmD
role: PRINCIPAL_INVESTIGATOR
References: