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

Primary Purpose

Covid-19 Vaccination

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Direct boost mRNA
Direct boost adeno
Post-poned boost mRNA
Post-poned boost adeno
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid-19 Vaccination focused on measuring Covid-19, Boost

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • AmsterdamUMC
  • UMCG
  • LUMC
  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Direct boost mRNA

Direct boost adeno

Post-poned boost mRNA

Post-poned boost adeno

Arm Description

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 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 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 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
What is the breadth of the immune responses after booster vaccination?
Outcome: PRNT against relevant variants in a random selection of study participants.
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
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.
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.

Full Information

First Posted
July 17, 2022
Last Updated
February 13, 2023
Sponsor
Erasmus Medical Center
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)
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1. Study Identification

Unique Protocol Identification Number
NCT05471440
Brief Title
SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in HCW
Acronym
SWITCHON
Official Title
SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Vaccination
Keywords
Covid-19, Boost

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct boost mRNA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Direct boost adeno
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Post-poned boost mRNA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Post-poned boost adeno
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Direct boost mRNA
Intervention Description
Participants will be boosted with a covid-19 vaccin after priming with mRNA
Intervention Type
Drug
Intervention Name(s)
Direct boost adeno
Intervention Description
Participants will be boosted with a covid-19 vaccin after priming with adeno
Intervention Type
Drug
Intervention Name(s)
Post-poned boost mRNA
Intervention Description
Participants will be boosted with a covid-19 vaccin after priming with mRNA
Intervention Type
Drug
Intervention Name(s)
Post-poned boost adeno
Intervention Description
Participants will be boosted with a covid-19 vaccin after priming with adeno
Primary Outcome Measure Information:
Title
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?
Description
Outcome: Level and fold change of antibodies determined by a quantitative IgG assay comparing the Janssen primed and mRNA-based primed HCW.
Time Frame
28 days
Title
Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?
Description
Outcome: Level of antibodies and T-cell responses 7 and 28 days post boost in DB versus PPB group.
Time Frame
28 days
Title
What is the breadth of the immune responses after booster vaccination?
Description
Outcome: PRNT against relevant variants in a random selection of study participants.
Time Frame
28 days
Title
What is the predictive value of immune responses on day 7 post boost?
Description
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
Time Frame
28 days
Title
What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?
Description
Outcome: Adverse events (AE) first 7 days after an additional boost between Janssen and mRNA primed HCW.
Time Frame
7 days
Title
Initial examination of breakthrough infections before and during study period
Description
Outcome: Database of breakthrough infections in included participants based on positive PCR, self-reported positive lateral flow test, or detection of N-specific antibodies.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Gene expression profiles associated with recall response (PAXgene tube)
Time Frame
28 days
Title
SARS-CoV-2-specific T-cell responses
Description
PBMC, assessed by activation-induced marker assay and / or TCRbeta sequencing
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo van der Kuy, PharmD
Organizational Affiliation
Erasmus MC, Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
AmsterdamUMC
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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