November 14, 2025 | 04:14 pm
TEMPO.CO, Jakarta - The Indonesian Food and Drug Monitoring Agency (BPOM) has approved Phase I clinical trials for AdTB105K, an inhalable tuberculosis (TB) vaccine developed by CanSino Biologics Inc. in collaboration with PT Etana Biotechnologies Indonesia.
The approval was announced by BPOM Chief Taruna Ikrar during a press briefing at Islamic Hospital Jakarta–Cempaka Putih on Thursday, November 13, 2025.
The authorization marks the start of the first human trials for the experimental vaccine, which is designed to trigger a stronger immune response in the respiratory tract, the primary site where Mycobacterium tuberculosis enters the body.
Taruna underscored the global urgency of TB control efforts. According to the World Health Organization (WHO), TB remains the world’s deadliest infectious disease, with 10.6 million new cases and more than 1 million deaths every year.
Indonesia carries the second-highest burden, reporting over 1 million cases and 125,000 deaths annually.
“TB continues to be a major global health challenge, and Indonesia is one of the countries most affected,” Taruna said.
“Launching clinical trials for an inhalable TB vaccine is a critical step toward developing more effective prevention tools.”
The AdTB105K vaccine uses an adenovirus type 5 (Ad5) platform carrying three key TB antigens—Mtb32A, Mtb39A, and Ag85A. Administering the vaccine through inhalation is expected to boost both mucosal and systemic immunity, offering a potentially stronger defense against infection.
Deputy Health Minister Benjamin Paulus Octavianus, who attended the event, emphasized the government’s commitment to accelerating medical innovation to combat the TB epidemic.
“President Prabowo has given me a special mandate to address TB in Indonesia. As a lung specialist, I feel personally responsible for advancing this mission,” he said.
He described the inhalable vaccine as a promising step forward in strengthening national TB control efforts.
BPOM issued the Clinical Trial Approval (CTA) on May 14, 2025, following facility inspections completed on October 6-7, 2025. The Phase I trial will enroll 36 healthy volunteers aged 18–49 to evaluate safety and immune response, with a six-month monitoring period after the single-dose administration.
Taruna said BPOM will oversee the research closely. “We fully support the development of this inhalable TB vaccine, from regulatory guidance to on-site inspections. We will ensure that the entire process adheres to safety, quality, and ethical research standards,” she said.
The development of this inhalable vaccine is seen as a significant milestone for Indonesia’s efforts to build domestic vaccine capabilities, particularly for high-burden diseases like TB.
“We hope this clinical trial will produce strong scientific data and support Indonesia’s progress toward greater self-reliance in TB vaccine innovation,” Taruna added.
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