30-03-2025
Oxford University launches trial for new tuberculosis vaccine
The safety of a new tuberculosis (TB) vaccine is being tested in an Oxford University trial.
In partnership with the Coler Lab at Seattle Children's Research Institute, the university has initiated the TB045 trial to evaluate the vaccine's safety and the immune response in healthy adult volunteers.
In 2023, TB, a disease caused by the bacterium mycobacterium tuberculosis, was the leading cause of death from an infectious disease globally.
It usually affects the lungs, with symptoms including feeling tired or exhausted, a cough that lasts more than three weeks, or a loss of appetite.
The only current licensed vaccine against TB is Bacillus Calmette-Guérin (BCG), which has remained unchanged for more than a century.
The University of Oxford trial (Image: University of Oxford) Though safe for infants, BCG does not provide lifelong protection and is given as an injection at birth.
The need for an effective vaccine to reduce the spread of TB, prevent active disease progression, and save lives is urgent, the researchers said.
The Jenner Institute at Oxford University is developing a human challenge model to test new TB vaccines.
Challenge models, used for vaccines like malaria, test if the vaccine works before larger field studies.
In the TB045 trial, 24 volunteers will receive the new TB vaccine, ID93+GLA-SE, and 24 will be in the control group, receiving no vaccine.
All participants will be challenged with BCG to assess their immune response to ID93+GLA-SE after the aerosol mycobacterial challenge.
Fourteen days post-infection, a medical procedure will obtain lung samples to check if BCG remains in the airways, indicating the vaccine's potential success against Mycobacterium tuberculosis.
Professor Helen McShane, professor of vaccinology at Oxford's Jenner Institute, said: "The only vaccine we currently have against TB is the BCG, which unfortunately is not very effective against lung TB.
"We are looking at ways to deliver vaccine to the cells that will be the first to encounter TB bacteria, and this trial should give us important information about how our lungs respond to the early stages of infection.
"It will also be vitally important in the development of inhaled vaccines, which could be a much more effective way of protecting against many respiratory illnesses."
This study is the first to employ an aerosol BCG-challenge model for a new TB vaccine.
It is funded by the National Institute of Health's National Institute of Allergy and Infectious Diseases as part of the IMPAc-TB consortium.
The study began vaccinating participants in January and the team is looking for healthy volunteers, both those who have had a BCG vaccine, and those who have never had a BCG vaccine.
