SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in HCW

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2023-08-30

Brief Summary

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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?"

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Detailed Description

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Conditions

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Covid-19 Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Direct boost mRNA

Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.

Group Type ACTIVE_COMPARATOR

Direct boost mRNA

Intervention Type DRUG

Participants will be boosted with a covid-19 vaccin after priming with mRNA

Direct boost adeno

Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.

Group Type ACTIVE_COMPARATOR

Direct boost adeno

Intervention Type DRUG

Participants will be boosted with a covid-19 vaccin after priming with adeno

Post-poned boost mRNA

Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.

Group Type ACTIVE_COMPARATOR

Post-poned boost mRNA

Intervention Type DRUG

Participants will be boosted with a covid-19 vaccin after priming with mRNA

Post-poned boost adeno

Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.

Group Type ACTIVE_COMPARATOR

Post-poned boost adeno

Intervention Type DRUG

Participants will be boosted with a covid-19 vaccin after priming with adeno

Interventions

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Direct boost mRNA

Participants will be boosted with a covid-19 vaccin after priming with mRNA

Intervention Type DRUG

Direct boost adeno

Participants will be boosted with a covid-19 vaccin after priming with adeno

Intervention Type DRUG

Post-poned boost mRNA

Participants will be boosted with a covid-19 vaccin after priming with mRNA

Intervention Type DRUG

Post-poned boost adeno

Participants will be boosted with a covid-19 vaccin after priming with adeno

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes