E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To study the necessity to boost healthcare workers (which arre representative for the dutch population) with a COVID vaccin by measuring the immunogenicity at 7 days and 28 days.. |
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E.1.1.1 | Medical condition in easily understood language |
To study the necessity to boost healthcare workers (which arre representative for the dutch population) with a COVID vaccin by measuring the immunogenicity at 7 days and 28 days.. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main aim of this proposal is to determine whether it is necessary to boost the healthy population in the autumn. The primary objective is to determine the fold change in antibody level at day of boost and 28 days after an additional COVID-19 booster vaccination in the direct boost group, comparing Janssen with mRNA-primed HCW.
To specifically answer the main aim, we have defined two questions with the following outcome parameters:
1. 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?
2. Does booster vaccination lead to a rapid secondary recall respons, indicative of immunological memory?
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E.2.2 | Secondary objectives of the trial |
1. 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.
2. What is the breadth of the immune responses after booster vaccination? Outcome: PRNT against relevant variants in a random selection of study participants.
3. What is the predictive value of immune responses on day 7 post boost? Outcome: Relationship between antibodies and T-cell responses on day 7 and 28 post boost.
4. 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 boost between Janssen and mRNA primed HCW.
5. What is the prevalence of breakthough infections during the 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants will be recruited from both the SWITCH-trial (Janssen primed HCWs)(1-3) and the Erasmus MC HCW-study (mRNA primed HCWs)(4, 5), as these participants are well characterized and documented in earlier responses to COVID-19 vaccinations. Participants may participate regardless of a previous SARS-CoV-2 infection. By randomizing over the different groups, we assume that the experienced infections are equally distributed over the groups. To assess whether this was truly the case, N-specific antibodies will be retrospectively measured in the pre boost sample from all participants. |
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E.4 | Principal exclusion criteria |
1. HCW younger than 18 2. HCW that are pregnant or have a wish to become pregnant within 6 months 3. All regular contra-indications of the vaccines will be applied
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Level of antibodies and T-cell responses 2. PRNT against relevant variants in a random selection of study participants. 3. Adverse events (AE) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood will be drawn at baseline and postboost at day 7, 28 and 84. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The comparator is a group that receives at another timepoint |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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12 months after the vaccination (last visit) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |