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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002560-73 | EudraCT Number |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Leiden University Medical Center | OTHER |
| University Medical Center Groningen | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct boost mRNA | Drug | Participants will be boosted with a covid-19 vaccin after priming with mRNA |
|
| 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? | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| What is the breadth of the immune responses after booster vaccination? |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression profiles associated with recall response (PAXgene tube) | 28 days | |
| SARS-CoV-2-specific T-cell responses | PBMC, assessed by activation-induced marker assay and / or TCRbeta sequencing | 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo van der Kuy, PharmD | Erasmus MC, Rotterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AmsterdamUMC | Amsterdam | 1105AZ | Netherlands | |||
| UMCG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39107860 | Derived | 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. | |
| 37088096 |
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All data will be shared upon a reasonable request to the PI of the study.
These data will become available 3 months after the start of the trial
a reasonable request
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| OTHER |
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
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|
| Direct boost adeno | Drug | Participants will be boosted with a covid-19 vaccin after priming with adeno |
|
| Post-poned boost mRNA | Drug | Participants will be boosted with a covid-19 vaccin after priming with mRNA |
|
| Post-poned boost adeno | Drug | Participants will be boosted with a covid-19 vaccin after priming with adeno |
|
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? | 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? | 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 | 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 |
| Groningen |
| 9713GZ |
| Netherlands |
| LUMC | Leiden | 2333ZA | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| 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. |
| 36524126 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |