Phase 2 Clinical Trial of RSV Vaccine Announced - Drug Discovery and Development

COPENHAGEN, Denmark — Bavarian Nordic A/S has announced the initiation of the first Phase 2 clinical study of MVA-BN RSV, its novel, broad spectrum, vaccine candidate against RSV (respiratory syncytial virus).

The study, which is being conducted in the U.S., will enrol 400 healthy subjects, aged 55 or older who will be randomized into five groups of 80 subjects each. Subjects will receive two administrations four weeks apart of either low or high doses of MVA-BN RSV and/or placebo, in order to identify the optimal dose and schedule for future studies. More information on the trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT02873286.

Top-line results from the study are anticipated around mid-2017 and will provide important information for a subsequent Phase 2b field efficacy study, which is planned for initiation later in 2017.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: “Advancing our RSV program into Phase 2 is an important milestone for Bavarian Nordic in our efforts to develop a vaccine which potentially offers broad protection against the virus. RSV remains an area of high unmet medical need with no approved vaccine available. This Phase 2 study represents an essential step in the successful development of any vaccine; to ensure we establish an ideal dose and dosing regimen, prior to exploring this candidate in larger studies. In this study we will evaluate both a single vaccination, as well as a prime-boost approach that will determine which regime induces prolonged immune responses against RSV.”

MVA-BN RSV represents a new vaccine approach specifically designed to target five different RSV proteins to ensure a broad immune response against both RSV subtypes (A & B). Extensive preclinical studies have shown that MVA-BN RSV induces a balanced immune response comprised of both antibodies and T cells, in a similar fashion to the natural response to an RSV infection. These results were confirmed in a Phase 1 study in healthy adults, reported in May 2016, which showed that MVA-BN RSV significantly boosted antibodies and T cells against both RSV subtypes. The vaccine was well tolerated, with no unexpected or serious adverse reactions. The vast majority of events represented local and systemic reactions typical for vaccines.