Bavarian Nordic reports positive results from human challenge trial of MVA-BN RSV a RSV vaccine candidate.
Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. A total of 61 subjects were evaluable.
The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study. At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections.
Pending further analysis of the current RSV infection rates, discussions with regulatory authorities about the Phase III design, and funding/partnering considerations, the Company will determine the immediate next steps and expects to communicate these during fourth quarter of 2021.
No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in phase 1 and phase II clinical studies.
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