Researchers from Seattle-based Infectious Disease Research Institute have developed an experimental tuberculosis (TB) vaccine candidate called ID93. The National Institutes of Health (NIH) has reported the freeze-dried, temperature-stable candidate has begun an initial phase of clinical trials in humans.
The NIH’s National Institute of Allergy and Infectious Diseases is collaborating on the adaptive phase 1 clinical studies which are taking place at Missouri’s St Louis University School of Medicine Center for Vaccine Development.
Four proteins of Mycobacterium tuberculosis were used to create the candidate, which is a recombinant powder formulation vaccine. The proteins were mixed with an immunogenic protein, called GLA-SE. The freeze-dried nature of the vaccine enables it to be transported to hard-to-reach areas across the world in a cost-effective way.
A Worldwide Problem
In 2017, 10 million people around the world contracted TB, with 1.6 million people dying from the disease, according to the World Health Organization. The disease is among the top 10 causes of death worldwide, making the development of a cost-effective and successful vaccine of high priority with the objective of ending its spread across the planet.
Adaptive clinical trials, such as those carried out by research group richmondpharmacology.com/specialist-services/adaptive-phase-i-studies/
are used to evaluate treatments for such diseases. The US Food and Drug Administration currently only approves the use of Bacillus Calmette-Guerin (BVG) vaccine for the prevention of TB. However, the vaccine has proved unsuccessful in preventing the disease in adolescents and adults.
The ID93 candidate is seeking to prevent people from being reinfected with the disease if they have previously received the BCG vaccine or had any exposure to TB in another way.
Almost 50 volunteers between 18 and 55 years of age will take part in the clinical trial, receiving two vaccinations. One set of volunteers will receive ID93, while the other half will receive a previously trialled two-vial combination of ID93 and liquid GLA-SE. The volunteers will provide blood samples to allow researchers to study their immune response.
The vaccine has successfully completed phase 2a clinical trials in South Africa, where TB sufferers have been cured of the disease. By introducing such technologies at an early stage of the vaccine’s development, its introduction to hard-to-reach areas could be optimised, said Christopher Fox PhD, VP of Infectious Disease Research Institute.