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We are thrilled to announce that our CCHF DNA vaccine, targeting the nucleocapsid protein (N) of Crimean-Congo hemorrhagic fever virus, has received approval from the European Medicines Agency (EMA) for a Phase I clinical trial. This landmark approval marks a significant advancement in the quest for effective countermeasures against CCHF.

Crimean-Congo hemorrhagic fever (CCHF) poses pressing societal challenges, with no specific therapies available beyond physical barriers. The virus, transmitted by ticks, is currently spreading northward in Europe, potentially due to climate changes and new cases have been recently reported in Spain (May 2024).

The DNA vaccine, known as N-pVAX1, represents a cutting-edge approach to vaccination. By targeting the highly conserved N gene sequence, the vaccine is designed to induce immune responses capable of recognizing diverse viral strains across different geographic regions.

The EMA's approval is grounded in promising pre-clinical data demonstrating the vaccine's robust immunogenicity and protective efficacy against lethal CCHF disease. Pre-clinical studies revealed a significant reduction in viral replication across multiple organs, with the vaccinated groups exhibiting the lowest clinical disease scores.

The Phase I clinical trial will take place in Sweden and will focuse on evaluating the safety profile of the N-pVAX1 DNA vaccine.

This trial marks the culmination of extensive research efforts aimed at combatting CCHF and represents a crucial step towards developing a viable vaccine strategy against this deadly pathogen.

Stay tuned for updates as we embark on this critical milestone in the fight against Crimean-Congo hemorrhagic fever !