Bavarian Nordic completes enrollment in global phase III Trial of MVA-BN RSV vaccine for respiratory syncytial virus.
Bavarian Nordic A/S announced that the Company has completed the planned enrollment of subjects in the global, randomized, double-blind Phase III clinical trial of its investigational respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV in adults greater than 60 years of age
The trial was initiated in April 2022 and has now enrolled over 20,000 subjects within the expected time frame at 120 sites across the U.S. and Germany. The primary objective of the study will assess the efficacy of the vaccine candidate against lower-respiratory tract disease (LTRD) caused by RSV compared to placebo. Topline results are anticipated in mid-2023.
The "RSV Phase III trial is our largest single study to-date, and we are pleased to complete target enrollment within the projected timeframe. We would like to thank all the clinical trial sites and their personnel for their significant contribution to advancing our RSV vaccine candidate, and not least the many volunteers without whom innovation and progress in the development of novel vaccines would not be possible. Our RSV vaccine has shown great promise in clinical trials thus far confirming its significant potential to change the lives of adults at risk from RSV-related disease, and we look forward to seeing the results from the Phase III trial next year, “ said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
In parallel, Bavarian Nordic is also running a global Phase III trial of its COVID-19 booster vaccine candidate. Enrollment in this trial is progressing well and on target to allow for initial results to become available in early 2023.
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