This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

The VANIR Study for RSV Vaccine Research

Trial ID: NCT05238025
In the VANIR Study, we want to see if the study vaccine, called MVA-BN-RSV, can help protect seniors from severe or acute respiratory infection from RSV.

Trial Details

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.

Estimated Enrollment

20,000 Participants



Who Can Participate?

Participants must:

  • Be 65 years of age and older
  • Be willing to sign an Informed Consent document
  • Be in good general health

Participants must not:

  • Be under the age of 65

Site Locations

Click the Get Started button to complete the prescreener and enter your zip code to locate the study site nearest to you.

What to Expect

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:

  • Screening/Vaccination: usually the same day
  • Follow-up during RSV season (usually fall through late spring): 6-12 months
  • Extended follow-up period (optional): 12 months

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.

Frequently Asked Questions (FAQs)