COPENHAGEN, Denmark, December 14, 2016 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that it has completed enrollment of 400 subjects in a Phase 2 clinical study of MVA-BN® RSV, a novel, broad spectrum, vaccine candidate against RSV (respiratory syncytial virus).
The study is evaluating the safety and immunogenicity of different doses of MVA-BN RSV in healthy subjects aged 55 or older. Top-line results from the study are anticipated in mid-2017 and will provide essential information for subsequent, larger efficacy studies.
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.
Respiratory syncytial virus, or RSV, is the most common cause of bronchiolitis and pneumonia in infants and a significant cause of respiratory illness in older adults, resulting in a high number of hospitalizations. RSV infections are responsible each year for a similar number of deaths as the flu in children up to age 14, as well as in the elderly population. It is estimated that more than 64 million people are infected globally each year, yet unlike the flu, there is no vaccine to prevent RSV, presenting a large unmet medical need and market opportunity.