A new clinical trial called TB-45 to test tuberculosis (TB) vaccine safety – the first-in-human aerosol mycobacterial challenge infection model – has been launched.
The current TB prevention method is the Bacillus Calmette-Guérin (BCG) vaccine, which is safe for infants but does not provide life-long protection and drugs against the disease, nor is it enough to stop the financial and social burden of TB.
The need for a new vaccine is becoming more urgent due to the rise of drug resistance, and the increased susceptibility and severity of the disease in people co-infected with HIV.
Global infectious disease experts say investing in vaccine development and distribution is crucial for effective disease prevention and control, reports Open Access Government.
First aerosol model
A challenge model is employed to test if new vaccines work before more extensive field studies are performed, and historically, this model has been used to test other vaccines, such as malaria.
In this study by the University of Oxford’s Jenner Institute, in partnership with the Coler Lab at the Seattle Children’s Research Institute (SCRI), 24 volunteers will be given BCG as a representative mycobacterium aerosol challenge, as it would not be ethical to provide study participants with live Mycobacterium tuberculosis. The researchers will then give the volunteers the new vaccine called ID93+GLA-SE, and 24 will receive no vaccine.
Thereafter, 14 days later, lung samples will be obtained from all volunteers to see if BCG remains in their airways.
The results will imply whether the vaccine is likely to be successful against TB and whether it should be field-tested for further confirmation.
Professor Helen McShane, Professor of Vaccinology at Oxford’s Jenner Institute, said: “We are looking at ways to deliver vaccines to the cells that will first 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 developing inhaled vaccines, which could be a much more effective way of protecting against many respiratory illnesses.”
Open Access Government article – University of Oxford launches first human aerosol TB vaccine trial
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