6 July 2022
The University of Oxford has begun recruiting for a Phase I trial with a tuberculosis vaccine in human volunteers at Oxford to develop a new way to test the efficacy of future TB vaccines – with the first volunteers being challenged today (Wednesday).
It has not yet been possible to use a human challenge study to test a new TB vaccine because humans cannot be safely infected with the bacteria causing TB.
However, in this new study, volunteers will instead be ‘challenged’ with the BCG vaccine – which contains a similar bacterium to the one causing TB and which has safely been used as an injectable vaccine for decades – administered through aerosol inhalation with the aim of mimicking how TB bacteria enter the lungs. Researchers will then assess how much BCG is recoverable from lung washing samples taken from volunteers post vaccination. If it can be demonstrated that this approach is well tolerated, then this method could to test new TB vaccines in the future.
The TB044 study plans to recruit a sample of 12 people aged 18 to 50, in good health and who must have previously received a BCG vaccine. They will be split into four groups and participate in a dose escalation clinical challenge study – the first group will receive a very low dose, and as long as there are no side effects the second group will receive a slightly higher dose, and so on.
Following vaccination, participants will be monitored closely over six months and treated accordingly if they experience any adverse events. Results are expected in 2023.
Helen McShane, Professor of Vaccinology, Director of the Oxford NIHR Biomedical Research Centre and Chief Investigator of the trial, said:
‘The TB044 study is the latest step in developing a safe human challenge model which mimics the way that tuberculosis infection occurs. By building on previous studies from my lab in the Jenner Institute, we hope to be able to use a safe BCG challenge model to understand more about what happens in the early stages of tuberculosis infection.
‘This model could help us to both discover new markers of protection against tuberculosis, but also in the future as a way to test new vaccine regimes. Developing a successful vaccine against tuberculosis is an important piece in our armoury in combatting this important infectious disease which could save millions of lives.’
Timothy Fredsgaard-Jones, Clinical Research Fellow at the Jenner Institute and Lead Clinician of the trial, said:
‘Tuberculosis is the leading global cause of death from a single bacterium, infecting millions of people worldwide every year. Unfortunately, a significant proportion continue to get sick and die, even with antibiotics. Having an effective vaccine is really important in changing this.
‘A safe BCG challenge model would allow us to test novel vaccines regimens more quickly and understand which ones have the best chance of working. This trial gives people the opportunity of taking part in research which could ultimately improve the health of people all around the world.’
The US-based National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) are funding the study.
Volunteers interested in enrolling on the study can do so online at https://www.jenner.ac.uk/volunteer/recruiting-trials/tb044
Notes for editors
For further information or to request an interview with the researchers, please contact: email@example.com or call 01865 280528.
Trial link – https://www.jenner.ac.uk/volunteer/recruiting-trials/tb044
Tuberculosis (also known as TB) is a disease caused by a bacterium (Mycobacterium tuberculosis). TB disease remains one of the top 10 causes of death worldwide. BCG (Bacille Calmette-Guérin) is the only vaccine currently licensed for use against TB, but it is not always protective.
It is difficult to develop new TB vaccines, as it is not easy to determine which ones will work well and which will not. In vaccine studies against other diseases, such as influenza and malaria, it is possible to experimentally infect volunteers with the disease in question to see if the vaccine being studied is effective. This is called a ‘challenge’ and is possible where the disease being studied is self-limiting or where safe, effective and short treatment regimens exist. This is not the case with TB, which requires a minimum of 6 months of treatment with multiple medications.
About the Jenner Institute
The Jenner Institute is based within the Nuffield Department of Medicine, University of Oxford, and is headquartered at the Old Road Campus Research Building, in Headington, Oxford. The Jenner Institute also supports senior vaccine scientists, known as Jenner Investigators, within many other departments across the University of Oxford, as well as externally within The Pirbright Institute and the Animal and Plant Health Agency.
The Jenner Institute brings together investigators who are designing and developing numerous vaccines to generate an exceptional breadth of scientific know-how and critical mass, whilst still allowing the individual investigators to remain independent and accountable to their funders and stakeholders.
The Jenner Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and is advised by the Jenner Institute Scientific Advisory Board.
About the University of Oxford
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