- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471440
SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in HCW (SWITCHON)
February 13, 2023 updated by: Hugo van der Kuy, Erasmus Medical Center
SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial
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?"
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
431
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amsterdam, Netherlands, 1105AZ
- AmsterdamUMC
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Groningen, Netherlands, 9713GZ
- UMCG
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Leiden, Netherlands, 2333ZA
- LUMC
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Rotterdam, Netherlands, 3015 GD
- Erasmus MC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant is willing and able to give written informed consent for participation in the trial.
- Adult (male/female) between 18 and 65 years old
- Sufficient level of the Dutch language to undertake all study requirements
Exclusion Criteria:
- Adults younger than 18 or older than 65 years.
- Adults primed with another vaccine than Janssen, Moderna or Pfizer.
- 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).
- Adults that are pregnant.
- Currently being treated for cancer.
- Severe kidney failure or dialyses dependent.
- Status after organ-, stem cell- or bone marrow transplantation.
- Use of immunosuppressant's.
- Epilepsy.
- HIV.
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following IM injections of vene puncture.
- Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc).
- Participants who are currently participating in another research trial.
- All regular contra-indications of the vaccines will be applied.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Participants will be boosted with a covid-19 vaccin after priming with mRNA
|
Active Comparator: 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.
|
Participants will be boosted with a covid-19 vaccin after priming with adeno
|
Active Comparator: 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.
|
Participants will be boosted with a covid-19 vaccin after priming with mRNA
|
Active Comparator: 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.
|
Participants will be boosted with a covid-19 vaccin after priming with adeno
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?
Time Frame: 28 days
|
Outcome: Level and fold change of antibodies determined by a quantitative IgG assay comparing the Janssen primed and mRNA-based primed HCW.
|
28 days
|
Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?
Time Frame: 28 days
|
Outcome: Level and fold change of antibodies and T-cell responses determined by a quantitative IgG assay and whole blood IFNγ release assay, respectively, comparing day 7 and 28 post-boost.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?
Time Frame: 28 days
|
Outcome: Level of antibodies and T-cell responses 7 and 28 days post boost in DB versus PPB group.
|
28 days
|
What is the breadth of the immune responses after booster vaccination?
Time Frame: 28 days
|
Outcome: PRNT against relevant variants in a random selection of study participants.
|
28 days
|
What is the predictive value of immune responses on day 7 post boost?
Time Frame: 28 days
|
Outcome: Correlation between antibodies and T-cell responses on day 7 and 28 post boost in % of the 28 day response for both level of antibodies and T-cell responses
|
28 days
|
What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?
Time Frame: 7 days
|
Outcome: Adverse events (AE) first 7 days after an additional boost between Janssen and mRNA primed HCW.
|
7 days
|
Initial examination of breakthrough infections before and during study period
Time Frame: 1 year
|
Outcome: Database of breakthrough infections in included participants based on positive PCR, self-reported positive lateral flow test, or detection of N-specific antibodies.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene expression profiles associated with recall response (PAXgene tube)
Time Frame: 28 days
|
28 days
|
|
SARS-CoV-2-specific T-cell responses
Time Frame: 28 days
|
PBMC, assessed by activation-induced marker assay and / or TCRbeta sequencing
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2022
Primary Completion (Actual)
September 15, 2022
Study Completion (Anticipated)
August 30, 2023
Study Registration Dates
First Submitted
July 17, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 22, 2022
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC-2022-0462
- 2022-002560-73 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data will be shared upon a reasonable request to the PI of the study.
IPD Sharing Time Frame
These data will become available 3 months after the start of the trial
IPD Sharing Access Criteria
a reasonable request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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