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

Phase

3

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)

What is a Clinical Research Study?

A clinical study is carefully supervised research that is done before an investigational procedure or product (like a new medication or new vaccine) can be made available to the public. Clinical research studies follow strict government regulations that help protect the safety and rights of study participants and provide accurate data so people can make informed decisions about their treatment options.

Participation in a clinical research study is completely voluntary, and investigators discuss all study details with their patients before they enter the study. These details include information about the study medication, what happens during the study, and any potential risks or side effects.

Doctors and scientists perform clinical research studies to:

Evaluate the safety and effectiveness of study drugs or devices
Answer specific health questions
Discover new ways to improve patient health

People may choose to participate in clinical research studies to:

Receive professional advice and/or care
Gain access to investigational treatments not yet available to the public
Contribute to the greater good of all patients by helping bring a new product to approval

Those considering participation can find more information at clinicaltrials.gov and are encouraged to talk with their physician and family about their health care choices.

This trial is not actively recruiting.