Comirnaty JN.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine

DRUG4 trials

Sponsors

Inserm, Centre Hospitalier Regional Universitaire De Tours, Sciensano, Amsterdam UMC Stichting, University Of Antwerp

Conditions

COVID-19Fibrodyplasia Ossificans Progressiva (FOP)Healthy persons and immunocompromised patients (nursing home residentsHealthy volunteersdialysis patients and kidney- and lung transplant patients) from age 18 till age 105

Phase 1

Randomized, controlled, multicenter Phase I/II study comparing the safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine expressing SARS-CoV-2 N/S recombinant proteins with a booster dose of COVID-19 mRNA vaccine in healthy adults

RecruitingCTIS2024-510589-17-00

Inserm, Centre Hospitalier Regional Universitaire De ToursHealthy volunteers

Start: 2025-05-09Target: 238Updated: 2025-09-05

Phase 4

LONGITUDINAL FOLLOW-UP OF SARS-COV-2 IMMUNITY IN IMMUNOCOMPROMISED POPULATIONS IN BELGIUM (COVICO) A non-commercial multicenter academic prospective cohort study during 2023-2026

Not yet recruitingCTIS2024-518098-33-01

Sciensanodialysis patients and kidney- and lung transplant patients) from age 18 till age 105, Healthy persons and immunocompromised patients (nursing home residents

Target: 360Updated: 2024-11-25

Safety, tolerability and immunogenicity of fractional, intradermal mRNA SARS-CoV-2 vaccination in patients with Fibrodysplasia Ossificans Progressiva (IVY trial)

Not yet recruitingCTIS2024-518686-10-00

Amsterdam UMC StichtingFibrodyplasia Ossificans Progressiva (FOP)

Target: 10Updated: 2025-01-27

A phase 4, open-label study to evaluate the short-term innate immune response after administration of a COVID-19 mRNA vaccine (Comirnaty JN.1®) in healthy adults aged 18 to 40 years.

CompletedCTIS2024-520304-26-00

University Of AntwerpCOVID-19

Start: 2025-05-05End: 2025-05-27Target: 20Updated: 2025-05-27