Valneva Reports Positive Phase 1 Interim Results for Its Chikungunya Vaccine Candidate

Phase 1 interim results showed an excellent immunogenicity profile after a single-shot vaccination and an acceptable safety profile, supporting further development.

  •  100% seroconversion rate achieved at Day 28 after a single-shot vaccination in a pooled analysis1 of all dose groups
  • Pooled analysis showed a high antibody response based on geometric mean titre
  • No serious adverse events or adverse events of special interest were reported up to Day 28

Valneva SE announced positive Phase 1 interim results for its Chikungunya vaccine candidate, VLA1553.

The primary objective of VLA1553-101 Phase 1 study was to assess the overall safety and immunogenicity profile 28 days after a single vaccination across three dose levels.

The interim results showed an excellent immunogenicity profile after a single vaccination with a 100% seroconversion rate2 achieved at Day 28 in a pooled analysis3 of all vaccinated groups. Results also showed 96.5% of subjects achieved at least a 16-fold increase in antibody titres and a high geometric mean titre, fully supporting VLA1553’s differentiated target product profile.

The pooled safety profile of all groups was considered acceptable and supports further development. No serious adverse events nor adverse events of special interest were reported up to Day 28 and the local tolerability was considered excellent. Systemic adverse events included short-term fever, headache and fatigue. As with other live-attenuated vaccines, transient cases of reduced levels of neutrophils, lymphocytes or leucocytes without clinical symptoms were observed in the pooled analysis.

 

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