Bavarian Nordic has started dosing patients in a Phase II extension study of its vaccine candidate MVA-BN RSV, which is being evaluated for the treatment of respiratory syncytial virus (RSV) infection.
Developed using the firm’s MVA-BN live virus vaccine platform technology, the candidate is designed to trigger an antibody and T-cell response against various respiratory syncytial virus (RSV) antigens.
The study aims to determine whether a single shot of MVA-BN RSV would be effective over multiple seasons or would be required annually.
Previously, the vaccine was observed to stimulate an immune response against the virus for one season.
Bavarian Nordic president and chief executive officer Paul Chaplin said: “Our plan of development is not only to establish the duration of response from our vaccine, which has already shown activity out to six months, but also to implement a human challenge study next year, which will give us an early indication of what level of efficacy we can anticipate with this vaccine.”
While the previous Phase II clinical trial was performed to establish dose and response to the MVA-BN RSV vaccine in 421 subjects, the booster study will include 86 participants who will be given a single shot of 1x108 or 5x108 of the vaccine.
Compared with the balance of the Phase II subjects, this study will monitor any boosting effects caused by administration of the additional shot.
In addition to RSV, Bavarian Nordic’s pipeline includes vaccine candidates for the treatment of infections caused by human papillomavirus (HPV), hepatitis B (HBV) and human immunodeficiency virus (HIV).