Safety and protection after vaccination against SARS-CoV-2, by injecting the vaccine in the skin

Establishing the safety, tolerability and immunogenicity of intradermal delivery of mRNA SARS-CoV-2 vaccine in healthy adults - IDSCOVA

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000454-26-NL

Enrollment

150

Registered

2021-03-25

Start date

2021-03-25

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

Healthy volunteers MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865

Interventions

Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna Product Code: EMEA/H/C/005791 Pharmaceutical Form: Concentrate and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age: 18 years or older 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: immunocompromised in any way pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety and tolerability of intradermal vaccination of COVID-19 Vaccine Moderna;Secondary Objective: Immunogenicity of intradermal vaccination of COVID-19 Vaccine Moderna;Primary end point(s): Safety and tolerability of intradermal injection of low dose COVID-19 Vaccine Moderna;Timepoint(s) of evaluation of this end point: f1rst week after every vaccination	—

Secondary

Measure	Time frame
Secondary end point(s): Immunogenicity after low dose intradermale vaccination of COVID-19 Vaccine Moderna;Timepoint(s) of evaluation of this end point: On D0 (before vaccination), D29 (time point after the first dose, on the day of the second vaccination), and on D36, D43, Month 7 and Month 13 (time points after the second dose)	—

Countries

Netherlands

Contacts

Public ContactA.H.E. Roukens

Leiden University Medical Center

a.h.e.roukens@lumc.nl

Outcome results

None listed

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