Safety and immunological response against SARS-CoV-2 after revaccination with mRNA-1273 with a ceramic skin patch

Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers - MILESTONE: iMmunogenicity IntradermaL cEramic Skin paTch sars-cOv-2 vacciNE

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006754-31-NL

Enrollment

Registered

2022-02-10

Start date

2022-03-22

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and immunogenicity after revaccination with Spikevax in healthy adults who have received Comirnaty as a primary vaccine

Interventions

Trade Name: Spikevax Pharmaceutical Form: Concentrate for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 18-40 primary vaccination series with Comirnaty healthy not immunocompromised not pregnant Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Study safety and immunogenicity against SARS-CoV-2 after revaccination with Spikevax in fractional doses and with a skin patch;Secondary Objective: cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses;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;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	—

Measure

Time frame

Main Objective: Study safety and immunogenicity against SARS-CoV-2 after revaccination with Spikevax in fractional doses and with a skin patch;Secondary Objective: cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses;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;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

—

Secondary

Measure	Time frame
Secondary end point(s): cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses;Timepoint(s) of evaluation of this end point: D1 = vaccination D29 = immune response monitoring	—

Countries

Netherlands

Contacts

Public ContactLG Visser

Leiden University Medical Center

l.g.visser@lumc.nl31715262613

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026