Jakarta, goldensamoyed Indonesia
—
Indonesia has started conducting clinical trials
vaccine
inhalation-based tuberculosis (TB), making Indonesia the first country to test this technology in
human
.This phase 1 research was led by Professor at the Faculty of Medicine, University of Indonesia, Erlina Burhan together with a team of national researchers.
“This is very prestigious because usually inhalation is given to sick people. This time it was given to healthy people to see their immunogenicity,” said Erlina when met at the clinical trial launch event in Jakarta, Thursday (13/11), citing
Sec
.
This inhaled TB vaccine was developed by the Chinese pharmaceutical company CanSino in collaboration with Etana, an Indonesian biopharmaceutical company.The vaccine uses a recombinant adenovirus type 5 viral-vector platform, and is designed as a booster for people who have received the BCG vaccine.
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In phase 1, 38 healthy participants will take part in the vaccination process with strict supervision according to Good Clinical Practice (GCP) standards.Even though the number of participants is limited, the process is said to be very complex.
“There were only 38 participants, but there were a lot of teams involved because the procedures were very strict. We want to ensure there are no deviations from the protocol,” explained Erlina.
The participant screening process has been underway since November 7, with around half of the candidates meeting the criteria.If everything goes according to plan, phase 1 is targeted to be completed in July 2026 before moving on to phases 2 and 3.
Inhalation is considered promising
Pre-clinical test results show that the inhalation method has better potential than injection, because it directly targets the mucosal immunity of the respiratory tract, the main entry point for bacteria that cause TB.
In this clinical trial, participants will receive the vaccine via nebulizer at two locations, namely at the Jakarta Cempaka Putih Islamic Hospital and the Persahabatan Hospital.
Until now, the BCG vaccine is still the only TB vaccine available in the world.Although effective in preventing severe TB in infants and young children, BCG is not able to provide optimal protection for adults against pulmonary TB.This is why vaccine innovation is an urgent need.
The Deputy Minister of Health of the Republic of Indonesia, Benyamin Paulus Octavianus, emphasized that eradicating TB is a national priority that has received direct attention from President Prabowo.
“This clinical trial is a strategic step towards eliminating TB by 2030. We hope that by 2029 this vaccine can be used widely,” he said.
The Head of BPOM, Taruna Ikrar, also expressed the same thing, who explained that approval was given after a comprehensive scientific evaluation, including proof of the safety and quality of the vaccine in pre-clinical trials.
Indonesia itself is among the eight countries with the highest TB cases in the world, accounting for most of the 68 percent of total global cases.Without innovation, the target of eliminating TB by 2030 is predicted to be difficult to achieve.
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.
(tis/tis)
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