CanSinoBIO Obtains Approval for Clinical Trial of Inhaled TB Vaccine in Indonesia

15 May 2025

For stronger immune responses in the respiratory tract and the lungs

CanSino Biologics Inc, based in China, has obtained an approval from the Badan Pengawas Obat danMakanan, Republic of Indonesia to initiate a clinical trial of its inhaled TB vaccine (Adenovirus Type 5 Vector) (the ‘inhaled TB Booster’).

Currently, the traditional Bacille Calmette-Guérin vaccine (BCG vaccine), also the only available tuberculosis vaccine in the world, is typically administered at birth. Additionally, the BCG vaccine declines over time and cannot enhance vaccine protection through booster doses, resulting in limited protection for adults. To address this deficiency, the inhaled TB vaccine is the first generation of a globally innovative tuberculosis booster vaccine for the BCG vaccine.

The inhaled TB Booster is designed to be administered via inhalation, inducing stronger immune responses in the respiratory tract and the lungs, the primary site of tuberculosis infection. This needle-free delivery method aims to clear tuberculosis bacilli and control latent infection, potentially achieving the effect of preventing infections and marking a breakthrough in tuberculosis prevention.

The Phase Ia and Phase Ib clinical trials for TB Booster were completed in Canada, and the clinical trial data demonstrated its safety and its effectiveness as a booster for BCG vaccine, as well as its superiority of mucosal immunity. The upcoming clinical trial in Indonesia will assess the inhaled TB Booster’s safety and immunogenicity of a single dose in adults aged 18 to 49 years.

Source: BioSpectrum