E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Safety and immunogenicity after revaccination with Spikevax in healthy adults who have received Comirnaty as a primary vaccine |
Veiligheid en immunogeniciteit van revaccinatie met Spikevax bij gezonde proefpersonen die de primaire vaccinatie serie met Comirnaty hebben gehad |
|
E.1.1.1 | Medical condition in easily understood language |
healthy persons |
gezonde proefpersonen |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 |
Study safety and immunogenicity against SARS-CoV-2 after revaccination with Spikevax in fractional doses and with a skin patch |
Onderzoeken van veiligheid en immunogeniciteit tegen SARS-CoV-2 na revaccinatie met Spikevax in kleine doses en met behulp van een huid patch |
|
E.2.2 | Secondary objectives of the trial |
cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses |
cellulaire immuniteit (B-cel en IGRA) na revaccinatie met Spikevax in kleinere doses |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age 18-40 primary vaccination series with Comirnaty healthy not immunocompromised not pregnant |
leeftijd 18-40 primaire vaccinatie serie met Comirnaty gezond niet immuungecompromitteerd niet zwanger
|
|
E.4 | Principal exclusion criteria |
having had covid-19 (anti-N and PCR) having received a covid-19 booster use of corticosteroids (systemic of topical) use of other immunesuppressants |
doorgemaakte covid-19 (anti-N en PCR) eerder een covid-19 booster gehad gebruik van corticosteroïden (systemisch of topical) gebruik van ander immuunsuppresiva |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Safety of intradermal vaccination with ceramic skin patch with Spikevax, compared to a similar dose intramuscularly - Antibody response after intradermal vaccination with ceramic skin patch with Spikevax, compared to a similar dose intramuscularly |
- veiligheid van intradermale vaccinatie van Spikevax met behulp van een keramische huid patch, vergeleken met dezelfde dosis intramusculair toegediend - antistofrespons na intradermale vaccinatie van Spikevax met behulp van een keramische huid patch, vergeleken met dezelfde dosis intramusculair toegediend |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Dx = screening for eligibility D1 = vaccination D15 = adverse event diary, immune response monitoring D29 = immune response monitoring M6 = final contact for SAE |
Dx = screening voor geschiktheid van deelname D1 = vaccinatie D15 = einde bijwerking dagboekje, immuunrespons monitoring D29 = immuunrespons monitoring M6 = laatste contact voor SAE |
|
E.5.2 | Secondary end point(s) |
cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses |
cellulaire immuniteit (B-cel en IGRA) na revaccinatie met Spikevax in kleinere doses |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
D1 = vaccination D29 = immune response monitoring |
D1 = vaccinatie D29 = immuunrespons monitoring |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
Spikevax - mRNA-1273 vaccine |
Spikevax - mRNA-1273 vaccine |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |