Covid-19 VaccinationSWITCHONNCT05471440
SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in HCW
A study testing Direct boost mRNA, Direct boost adeno and Post-poned boost mRNA in people with Covid-19 Vaccination, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19 Vaccination
- What is being tested?
- Direct boost mRNA, Direct boost adeno and Post-poned boost mRNA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 4 sitesNetherlands
- Study dates
- 20 Aug 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
AmsterdamUMC
Amsterdam, 1105AZ
UMCG
Groningen, 9713GZ
LUMC
Leiden, 2333ZA
Erasmus MC
Rotterdam, 3015 GD
About this study
Official title: 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?"
- Conditions
- Covid-19 Vaccination
- Being tested
- Direct boost mRNA, Direct boost adeno, Post-poned boost mRNA, Post-poned boost adeno
- Keywords
- Covid-19, Boost
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct boost mRNADrug
Participants will be boosted with a covid-19 vaccin after priming with mRNA
Direct boost adenoDrug
Participants will be boosted with a covid-19 vaccin after priming with adeno
Post-poned boost mRNADrug
Participants will be boosted with a covid-19 vaccin after priming with mRNA
Post-poned boost adenoDrug
Participants will be boosted with a covid-19 vaccin after priming with adeno
| Study group | Role | What they receive |
|---|---|---|
| Direct boost mRNA | Active comparator | 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. Receives: Drug: Direct boost mRNA |
| Direct boost adeno | Active comparator | 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. Receives: Drug: Direct boost adeno |
| Post-poned boost mRNA | Active comparator | 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. Receives: Drug: Post-poned boost mRNA |
| Post-poned boost adeno | Active comparator | 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. Receives: Drug: Post-poned boost adeno |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Outcome: Level and fold change of antibodies determined by a quantitative IgG assay comparing the Janssen primed and mRNA-based primed HCW.
Measured: 28 days
Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?
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.
Measured: 28 days
Secondary outcomes (5)
What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?
Outcome: Level of antibodies and T-cell responses 7 and 28 days post boost in DB versus PPB group.
Measured: 28 days
What is the breadth of the immune responses after booster vaccination?
Outcome: PRNT against relevant variants in a random selection of study participants.
Measured: 28 days
What is the predictive value of immune responses on day 7 post boost?
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
Measured: 28 days
What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?
Outcome: Adverse events (AE) first 7 days after an additional boost between Janssen and mRNA primed HCW.
Measured: 7 days
Initial examination of breakthrough infections before and during study period
Outcome: Database of breakthrough infections in included participants based on positive PCR, self-reported positive lateral flow test, or detection of N-specific antibodies.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start20 Aug 2022
- Primary completion15 Sep 2022
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid-19 VaccinationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Leiden University Medical Center, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Hugo van der Kuy, Erasmus Medical Center
- Investigators
- Hugo van der Kuy, PharmD, Principal investigator, Erasmus MC, Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471440
- Sponsor's protocol ID
- MEC-2022-0462
- Other IDs
- 2022-002560-73
- Acronym
- SWITCHON
- Status last verified
- Feb 2023
- First submitted
- 17 Jul 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared upon a reasonable request to the PI of the study.
Publications
Tan NH, Lafeber M, Sablerolles RSG, Veerman Roders I, van de Hoef A, van Grafhorst K, Visser LG, Postma DF, Goorhuis A, Rietdijk WJR, van der Kuy PHM. Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial. Trials. 2024 Aug 7;25(1):528. doi: 10.1186/s13063-024-08367-4.
PubMed 39107860Tan NH, Geers D, Sablerolles RSG, Rietdijk WJR, Goorhuis A, Postma DF, Visser LG, Bogers S, van Dijk LLA, Gommers L, van Leeuwen LPM, Boerma A, Nijhof SH, van Dort KA, Koopmans MPG, Dalm VASH, Lafeber M, Kootstra NA, Huckriede ALW, van Baarle D, Zaeck LM, GeurtsvanKessel CH, de Vries RD, van der Kuy PHM; SWITCH ON Research Group. Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON): results from the direct boost group of an open-label, multicentre, randomised controlled trial. Lancet Infect Dis. 2023 Aug;23(8):901-913. doi: 10.1016/S1473-3099(23)00140-8. Epub 2023 Apr 21.
PubMed 37088096Tan NH, Sablerolles RSG, Rietdijk WJR, Goorhuis A, Postma DF, Visser LG, Bogers S, Geers D, Zaeck LM, Koopmans MPG, Dalm VASH, Kootstra NA, Huckriede ALW, van Baarle D, Lafeber M, GeurtsvanKessel CH, de Vries RD, van der Kuy PM. Analyzing the immunogenicity of bivalent booster vaccinations in healthcare workers: The SWITCH ON trial protocol. Front Immunol. 2022 Nov 29;13:1067749. doi: 10.3389/fimmu.2022.1067749. eCollection 2022.
PubMed 36524126
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT05471440
- Acronym / sponsor ID
- SWITCHON / MEC-2022-0462
- Conditions
- Covid-19 Vaccination
- Keywords
- Covid-19, Boost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Leiden University Medical Center, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Direct boost mRNA | Active comparator | Drug: Direct boost mRNAParticipants 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. |
| Direct boost adeno | Active comparator | Drug: Direct boost adenoParticipants 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. |
| Post-poned boost mRNA | Active comparator | Drug: Post-poned boost mRNAParticipants 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. |
| Post-poned boost adeno | Active comparator | Drug: Post-poned boost adenoParticipants 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct boost mRNAParticipants will be boosted with a covid-19 vaccin after priming with mRNA | Drug | Direct boost mRNA |
| Direct boost adenoParticipants will be boosted with a covid-19 vaccin after priming with adeno | Drug | Direct boost adeno |
| Post-poned boost mRNAParticipants will be boosted with a covid-19 vaccin after priming with mRNA | Drug | Post-poned boost mRNA |
| Post-poned boost adenoParticipants will be boosted with a covid-19 vaccin after priming with adeno | Drug | Post-poned boost adeno |
Primary outcome
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.
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.
5 secondary outcomes
What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?
Time frame: 28 days
What is the breadth of the immune responses after booster vaccination?
Time frame: 28 days
What is the predictive value of immune responses on day 7 post boost?
Time frame: 28 days
What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?
Time frame: 7 days
Initial examination of breakthrough infections before and during study period
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 39107860Tan NH, Lafeber M, Sablerolles RSG, Veerman Roders I, van de Hoef A, van Grafhorst K, Visser LG, Postma DF, Goorhuis A, Rietdijk WJR, van der Kuy PHM. Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial. Trials. 2024 Aug 7;25(1):528. doi: 10.1186/s13063-024-08367-4.
- Derived from this study: PubMed 37088096Tan NH, Geers D, Sablerolles RSG, Rietdijk WJR, Goorhuis A, Postma DF, Visser LG, Bogers S, van Dijk LLA, Gommers L, van Leeuwen LPM, Boerma A, Nijhof SH, van Dort KA, Koopmans MPG, Dalm VASH, Lafeber M, Kootstra NA, Huckriede ALW, van Baarle D, Zaeck LM, GeurtsvanKessel CH, de Vries RD, van der Kuy PHM; SWITCH ON Research Group. Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON): results from the direct boost group of an open-label, multicentre, randomised controlled trial. Lancet Infect Dis. 2023 Aug;23(8):901-913. doi: 10.1016/S1473-3099(23)00140-8. Epub 2023 Apr 21.
- Derived from this study: PubMed 36524126Tan NH, Sablerolles RSG, Rietdijk WJR, Goorhuis A, Postma DF, Visser LG, Bogers S, Geers D, Zaeck LM, Koopmans MPG, Dalm VASH, Kootstra NA, Huckriede ALW, van Baarle D, Lafeber M, GeurtsvanKessel CH, de Vries RD, van der Kuy PM. Analyzing the immunogenicity of bivalent booster vaccinations in healthcare workers: The SWITCH ON trial protocol. Front Immunol. 2022 Nov 29;13:1067749. doi: 10.3389/fimmu.2022.1067749. eCollection 2022.
- Individual participant dataSharing planned: Yes. All data will be shared upon a reasonable request to the PI of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo van der Kuy, PharmD principal investigator
Erasmus MC, Rotterdam
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct boost mRNA, Direct boost adeno and Post-poned boost mRNA in people with Covid-19 Vaccination, run by Erasmus Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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? (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471440, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.