Sarah Gilbert on an Influenza Vaccine Formulated for Older Adults

Influenza season is upon us! With its peak estimated to be between December and February, it is important that all health care providers and your patients are vaccinated before influenza activity increases in the United States.

At World Vaccine Congress Europe 2018, researcher Sarah Gilbert spoke about her work on a novel vaccine targeted for patients aged 65 years or older. We reached out to Sarah to shed light on her research and what her findings mean for practice.

Sarah Gilbert is a Professor of Vaccinology at the University of Oxford in the United Kingdom. She also leads the Jenner Institute’s influenza vaccine program at the University of Oxford and is one of the founders of Vaccitech, which is now continuing the clinical development of improved influenza vaccines.

Infectious Diseases Consultant: You and your team have completed the first clinical efficacy study of an influenza vaccine designed to work through cellular immunity. Can you tell us more about that and how you formulated the vaccine?

Sarah Gilbert: The study, sponsored by Vaccitech, began in October 2017, and the first planned season was completed. However, owing to a change in vaccine recommendation for adults older than age 65 years in the United Kingdom for the 2018-2019 season, the second season will not go ahead. The trial was testing the new vaccine, MVA-NP+M1, given with the licensed quadrivalent influenza vaccine (QIV), with a control group receiving placebo plus QIV. Each vaccine was given as a separate injection into the same arm.

ID CON: How is this vaccine different than other influenza vaccines used in practice? Can this novel vaccine potentially be more effective for high-risk individuals?

SG: The vaccine boosts T-cell responses to two highly conserved influenza antigens, NP and M1. This cross-reactive immunity is expected to prevent influenza disease with any influenza A virus. Immunogenicity is not decreased in older adults, in contrast to QIV immunogenicity and efficacy.

ID CON: At World Vaccine Congress, you presented your trial data for this novel influenza vaccine regimen for individuals aged older than 65 years. How was the data received?

SG: As stated previously, the trial had completed one season and was then paused, but we are planning to start a larger study in Australia in March, again over 2 flu seasons. In addition, we will conduct influenza challenge studies in young healthy adults next year, this time with MVA-NP+M1 alone compared with placebo. The audience was very positive about the planned studies.

ID CON: What do your results mean for the future of influenza vaccination, specifically for the geriatric population who are at high risk of infection?

SG: We expect to be able to make influenza vaccination in older adults as effective as it is in younger adults and are focusing on this age group first, as the medical need is greatest.

ID CON: Because older adults are at high risk for influenza and complications, what is the next step in getting this vaccine approved for use in practice?

SG: We will start a new phase II proof of concept efficacy study in 2019 with results in 2021. If positive, we would then move to a phase III trial to collect the data that would be needed for vaccine licensure. In parallel with that, preparations for manufacturing large numbers of doses will be needed.

Reference:

Gilbert S. Phase IIb trial of a novel influenza vaccine regimen for the over 65s. Presented at: World Vaccine Congress Europe 2018; October 29-31, 2018; Lisbon, Portugal.