The VANIR Study is a randomized, double-blind, phase 3 trial to assess the clinical efficacy and safety of the recombinant MVA-BN®-RSV vaccine in adults over 65.
All vaccinated participants will be followed for respiratory tract disease for at least 6 months and up to 12 months, starting the day after vaccination.
Except for the combined screening and vaccination visit (Visit 1), symptom visits for collection of nasopharyngeal swabs to confirm RSV disease, unscheduled visits (e.g., due to adverse events and evaluation of symptoms), and visits for blood draws for immunogenicity testing in a subgroup, all contacts with participants will take place through an app or by telephone calls with the study team calling participants monthly to assess any RSV symptoms and health status.
Click the Get Started button to complete the prescreener and enter your zip code to locate the study site nearest to you.
If you qualify and choose to participate, you will read and sign a consent form and receive a guide with more information about study visits.
The VANIR Study includes:
By taking part in the VANIR Study, you will be randomly assigned (like the flip of a coin) to receive one dose of study vaccine or placebo, which looks like the study vaccine but contains no active vaccine. Neither you nor the study team will know whether you received the study vaccine or placebo.
After one dose of the study vaccine or placebo, you will record any side effects or respiratory symptoms in a smartphone/tablet application. The study doctors will follow up with you monthly by phone for at least 1 RSV season (6-12 months). After the RSV season, the study team will determine whether an extended follow-up (up to an additional 12 months) is needed.