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

NCT05471440 | Unknown

• 2 other identifiers: MEC-2022-04622022-002560-73
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 4

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?"

Conditions

Covid-19 Vaccination

Keywords

Covid-19; Boost

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  28 days

Secondary Outcomes (5)

• What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?

  28 days

• What is the breadth of the immune responses after booster vaccination?

  28 days

• What is the predictive value of immune responses on day 7 post boost?

  28 days

• What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?

  7 days

• Initial examination of breakthrough infections before and during study period

  1 year

Other Outcomes (2)

• Gene expression profiles associated with recall response (PAXgene tube)

  28 days

• SARS-CoV-2-specific T-cell responses

  28 days

Study Arms (4)

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.

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.

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.

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.

Drug: Post-poned boost adeno

Interventions

Direct boost mRNA DRUG

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

Direct boost mRNA

Direct boost adeno DRUG

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

Direct boost adeno

Post-poned boost mRNA DRUG

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

Post-poned boost mRNA

Post-poned boost adeno DRUG

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

Post-poned boost adeno

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Leiden University Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (4)

AmsterdamUMC

Amsterdam, 1105AZ, Netherlands

Location

UMCG

Groningen, 9713GZ, Netherlands

Location

LUMC

Leiden, 2333ZA, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 39107860 DERIVED

• Tan 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.

  PMID: 37088096 DERIVED

• Tan 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.

  PMID: 36524126 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hugo van der Kuy, PharmD

  Erasmus MC, Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Department Clinical Pharmacy/ Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 22, 2022
• Study Start: August 20, 2022
• Primary Completion: September 15, 2022
• Study Completion: August 30, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: These data will become available 3 months after the start of the trial
• Access Criteria: a reasonable request

Locations

NL (4)