Scanning electron micrograph of the bacterium MYCOBACTERIUM TUBERCULOSIS that causes tuberculosis. Courtesy of the National Institute of Allergy and Infectious Diseases (NIAID).
The results of phase 1 clinical trials of the world’s first room temperature tuberculosis vaccine have been released. It has been shown to induce the production of high levels of antibodies and even create T cells, which are immune cells. It was analyzed that the effect would last for 3 months if stored at 37 degrees and up to 24 months if stored at 5 degrees. It is expected to be helpful in responding to tuberculosis, which is the second leading cause of death worldwide.
A research team at the Access to Advanced Health Institute (AAHI), a non-profit biotech research institute in the United States, published the results of the phase 1 clinical trial of the tuberculosis vaccine candidate ‘NCT03722472’ in the international journal ‘Nature Communications’ on the 6th.
A total of 48 participants participated in the phase 1 clinical trial. The research team divided the participants into two groups. Twenty-three received the tuberculosis vaccine after processing so that it could be stored at room temperature, and 22 received the tuberculosis vaccine before treatment. Both groups were vaccinated twice each on day 0 and day 56, the starting date of the experiment.
After vaccination, the immune response was analyzed by taking blood, tear, and nasal samples. Tear and nasal samples were taken at the start of the experiment and at 70 and 224 days after vaccination, and blood samples were taken at days 0, 7, 14, 56, 64, 70, 84 and 224 days after vaccination. collected on
Analysis of the samples showed that both vaccines induced high levels of antibodies and immune cell production. In particular, it was found that the effect of the vaccine treated at room temperature was higher than that of the untreated vaccine. The research team said, “This clinical trial proved that the vaccine is safe and effective,” and “it was also proven that the vaccine stored at room temperature elicits a stronger immune response.”
This study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The research team expects that this research will facilitate the supply of vaccines to African regions where the ‘cold chain’, a system for distributing vaccines at low temperatures, is not properly equipped. Corey Casper, CEO of AAHI, said, “Equitable access to vaccines has been greatly hindered by the cold chain. This study is an important achievement in addressing this problem.”
In Korea, the NA Vaccine Research Institute is developing a tuberculosis vaccine stored at room temperature. It was selected as the ‘1st Global Vaccine Technology Leading Project Group New Support Target Project’ of the Global Vaccine Technology Leading Project Group newly established by the Ministry of Health and Welfare, and is developing a peptide tuberculosis vaccine that can be stored at room temperature.