Bavarian Nordic has started the Phase 2 extension study of MVA-BN RSV, a universal vaccine candidate designed to elicit a broad antibody and T-cell response against multiple respiratory syncytial virus (RSV) antigens.
As BN noted, the study is designed to help determine whether a single shot administration of vaccine is required annually, or if it remains effective over multiple seasons. The vaccine has previously shown to induce an immune response against RSV for a single season.
The initial Phase 2 study enrolled 421 volunteers to determine dose and response to MVA-BN RSV.
“This added booster portion of the study will enroll 86 of these subjects to receive a single shot of either low (1×108) or high (5×108) dose of the vaccine. The study will determine what, if any, boosting effect is seen from the additional shot when compared to the balance of subjects in the Phase 2 study, helping to determine whether MVA-BN RSV should be administered annually, or if the durability of the vaccine could extend across multiple seasons,” the company explained.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said that the development of an RSV vaccine continues to be a significant healthcare need in the world. He said that BN’s plan of development is not only to establish the duration of response from the vaccine, which has already shown activity out to 6 months, but also to implement a human challenge study next year. “(That) will give us an early indication of what level of efficacy we can anticipate with this vaccine,” Chaplin said.