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| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/20/BVW5 | Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC | Nouscom Srl | Humans | The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene. |
| Only notified under the "contained use" procedure. Dossier submitted on . | A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |