Safety and immunological response against SARS-CoV-2 after revaccination with mRNA-1273 with a ceramic skin patch
Phase 1
- Conditions
- Safety and immunogenicity after revaccination with Spikevax in healthy adults who have received Comirnaty as a primary vaccineTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-006754-31-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
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
having had covid-19 (anti-N and PCR)
having received a covid-19 booster
use of corticosteroids (systemic of topical)
use of other immunesuppressants
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- 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<br>D1 = vaccination<br>D15 = adverse event diary, immune response monitoring<br>D29 = immune response monitoring<br>M6 = final contact for SAE
- Secondary Outcome Measures
Name Time Method 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<br>D29 = immune response monitoring