An interventional study of Direct boost mRNA and Direct boost adeno in Covid-19 Vaccination, sponsored by Erasmus Medical Center. Status unknown at 4 sites in Netherlands. Open to participants aged 18 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention
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?"
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 431 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Exclusion Criteria:
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
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
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
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
Participants will be boosted with a covid-19 vaccin after priming with mRNA
Participants will be boosted with a covid-19 vaccin after priming with adeno
Participants will be boosted with a covid-19 vaccin after priming with mRNA
Participants will be boosted with a covid-19 vaccin after priming with adeno
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.
Time frame: 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.
Time frame: 28 days
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Gene expression profiles associated with recall response (PAXgene tube)
Time frame: 28 days
SARS-CoV-2-specific T-cell responses
PBMC, assessed by activation-induced marker assay and / or TCRbeta sequencing
Time frame: 28 days
Plan to share: Yes — All data will be shared upon a reasonable request to the PI of the study.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
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