The world’s first NHS trial for a universal flu vaccine has recruited its first round of participants, with over 862 people signing up to take part since the trial launched in October 2017.
This marks the end of the first phase of the trial, which will open again for new participants at the start of the winter flu vaccination programme in late 2018.
Led by Oxford University, the trial investigates whether giving the new vaccine at the same time as the existing vaccine offers stronger protection against flu in over 65-year olds. Current vaccines are only effective in 30–40% of over 65s, as the immune system weakens with age. Researchers believe the vaccine could have a major impact on the worldwide fight against the virus, which affects about a billion people worldwide a year with 250,000 to 500,000 annual deaths.
The vaccine was first developed by Oxford University’s Jenner Institute with Vaccitech, a spin-out company from the institute now continuing clinical development.
Conventional influenza vaccines include parts of the virus’s outer shell, which the influenza virus is constantly changing. This means scientists need to predict those changes and update the vaccine each year.
The new vaccine being tested uses a different mechanism to get the body to protect against the influenza virus – by stimulating the immune system to boost the number of influenza-specific T-cells, instead of antibodies, that kill the virus as it tries to spread throughout the body.
Previous research found that these T-cells can help fight more than one type of flu virus because they recognise core proteins within the virus that, unlike those on the surface, do not change year-on-year. This suggests this new vaccine could be a longer-term line of defence, protecting more people and reducing the severity and duration of flu.
10,000 over 65s registered in six Berkshire and Oxfordshire GP practices were initially invited to take part in the trial, which is managed by Oxford University’s Primary Care Clinical Trials Unit and supported by the NIHR Clinical Research Network Thames Valley and South Midlands. By the end of next winter, the researchers aim to recruit a total of 2,000 people aged over 65s.
Professor Chris Butler, Director of Oxford University’s Primary Care and Vaccines Clinical Trials Unit said:
“An influenza vaccine that gets around the flu virus’s ability to alter its outer shell season-by-season would be a huge step forward in saving lives, and indeed would make a major contribution to the sustainability of the NHS and health services around the world.
We are immensely proud to be leading the first major evaluation of this novel vaccine in general practice. The trust and cooperation between patients, the participating practices, the scientists, Vaccitech, and the incredible research team in the Trials Unit, has allowed us to randomise over 800 participants in the INVICTUS study this winter.
Everyone, especially the study participants who have so readily volunteered to participate, is making huge contribution to generating unique evidence to underpin preventative health care in this critical area.”
Professor Sarah Gilbert of the Jenner Institute and co-founder of Vaccitech said:
“This is a very important clinical trial representing a major milestone in the development of a new type of flu vaccine. We are very grateful to the volunteers who are helping us test this vaccine. The feedback that they are giving us is that they want more effective flu vaccines to be available.”