First clinical trial authorisation under ECTR is a fact

The clinical trial application of the LARISSA study is the first application submitted successfully by CR2O under the new European Clinical Trial Regulation (ECTR).

The ECTR is the new regulation for receiving ethical and regulatory approval in the European Union and European Economic Area by using the Clinical Trial Information System (CTIS) centralized portal to submit clinical trial applications.

LARISSA is a first in human Phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose vaccine candidate against Rift Valley fever (RVF) virus in healthy adult subjects. The vaccine is a novel live-attenuated RVF vaccine virus to generate a lasting immune response against the disease. The study will be performed at the Centre of Vaccinology in Belgium and first subject randomized is expected in August 2022.

Official approval was obtained on July 26th, which made CR2O one of the first successful users of the new ECTR regulation!

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