Clinical Trials

Date: 2015-08-18

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: Bavarian Nordic (Denmark)

Product: MVA-BN® RSV vaccine

Action mechanism: vaccine

Disease: respiratory syncytial virus infections

Therapeutic area: Infectious diseases - Respiratory diseases

Country: USA

Trial details:

This randomized, single-blind, placebo-controlled phase I trial will evaluate the safety, tolerability and immunogenicity of the recombinant MVA BN® RSV vaccine in healthy adult subjects. A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV. Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 10⁷TCID50 per 0.5 ml or with placebo. (NCT02419391)

Latest news:

• On August 18, 2015, Bavarian Nordic announced the initiation of a Phase 1 clinical study of its MVA-BN® RSV vaccine candidate against respiratory syncytial virus (RSV), the first study to evaluate the vaccine candidate in humans. The study, which is being conducted in USA, will evaluate the safety, tolerability and immunogenicity of a recombinant MVA-BN-based RSV vaccine in 63 healthy adults, ages 18-65. Subjects will be enrolled into three groups to receive different doses of MVA-BN RSV. One group will enroll subjects of 50-65 years of age who will receive a higher dose of MVA-BN RSV in order to evaluate the immune responses in an elderly population, which is a key target for the vaccine. Volunteers in each group will be randomized to receive two vaccinations of MVA-BN RSV vaccine or placebo.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: \"The addition of RSV to our clinical pipeline significantly expands the commercial potential of our MVA-BN vaccine platform technology. RSV is an exciting opportunity as it represents an area of high unmet medical need with no approved vaccine available. Based on the broad protection seen in our preclinical data, we believe that MVA-BN has the potential to address this opportunity. Once data from this initial study are available, we plan to aggressively pursue the development of this promising vaccine candidate in all potential risk populations, including elderly and young children."