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Clinical Trial Results From MVA-BN-RSV Vaccine Candidate for RSV Prevention in Older Adults

Ting Shi, PhD

Chancellor's Fellow
Usher Institute
University of Edinburgh
Edinburgh, United Kingdom

Ting Shi, PhD, has no relevant financial relationships to disclose.

View ClinicalThoughts from this Author

Released: August 18, 2022

Key Takeaways

  • MVA-BN-RSV is a vaccine candidate for prevention of respiratory syncytial virus in older adults and recently was added to the priority medicines (PRIME) scheme by the European Medicines Agency and awarded Breakthrough Therapy Designation by the FDA.
  • A large phase III trial was initiated in April 2022 and should provide more robust data on the benefits of this vaccine.

Respiratory syncytial virus (RSV) is one of the important viral pathogens identified in older adults with acute respiratory infections. It is an increasingly recognized cause of illness in adults with underlying health conditions.

Recently, the European Medicines Agency granted access to its priority medicines (PRIME) scheme for MVA-BN-RSV, an RSV vaccine candidate for the prevention of RSV in older adults. This vaccine also was also given Breakthrough Therapy Designation by the FDA. MVA-BN-RSV and Ad26.RSV.preF, an RSV vector vaccine, are the only RSV vaccines to receive these designations.

This live recombinant vaccine incorporates different RSV antigens (RSV surface proteins F and G for both A and B subtypes and internal antigens N and M2) to stimulate a broad immune response against both RSV subtypes (RSV-A and RSV-B).

Phase I and II trials of the MVA-BN-RSV vaccine are complete, and a phase III trial is ongoing.

Phase I Trial (NCT02419391)
This study investigated vaccine safety, reactogenicity, and immunogenicity in a randomized, single blind placebo-controlled, single-center study with 63 healthy participants aged 20-62 years. The results demonstrated that the vaccine induced broad cellular immune response against all 5 RSV protein inserts and humoral immune response against both RSV subtypes without significant safety signals. However, these findings were based on a small sample size.

Phase II Trial (NCT02873286)
This trial evaluated immune response to the vaccine to identify the optimal dose and vaccination schedule. It was a randomized, single-blind, placebo-controlled study with 420 adults aged 55 years or older. The study showed that this vaccine induced a broad immune response that can last ≥6 months—covering an entire RSV season—and can be boosted at 12 months with an annual booster vaccination.

Phase II Trial (NCT04752644)
This randomized, double-blind, placebo-controlled study in healthy adults aged 18-50 years showed a reduction in viral load among patients vaccinated with MVA-BN-RSV (n = 30) compared with placebo (n = 31). The vaccinated patients also showed reduced clinical symptoms associated with RSV infections. However, this study was based on small sample size (N = 61), and the nonspecific nature of clinical signs related to RSV infections makes it difficult to distinguish which clinical symptoms were attributed to RSV infections vs other respiratory illnesses.

Phase III Trial (NCT05238025)
This randomized, double-blind study of MVA-BN-RSV in adults aged 60 years or older was initiated in April 2022. The primary completion date (the last participant received an intervention to collect final data) is estimated to be in November 2023, and the study completion date is estimated to be in December 2024. Investigators plan to enroll 20,000 adults across 115 sites in the United States and Germany. Findings from this trial will be more robust with this larger sample size.

Your Thoughts?
Would you recommend an RSV vaccine for your older adult patients if approved? Join the discussion by posting a comment.

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