Chinese biopharmaceutical company Yisheng Biopharma has completed its Phase I clinical trial of PIKA hepatitis B vaccine to provide prophylactic and therapeutic benefits against hepatitis B virus infection.
The vaccine uses toll-like receptor-3 (TLR-3) agonist technology platform PIKA adjuvant technology, which has been designed to deliver toll-like receptor-3 (TLR-3) agonist molecules to activate the innate immune cells such as dendritic cells, macrophages and NK cells.
PIKA adjuvant has been formulated as a component of PIKA adjuvant-based hepatitis vaccine. The PIKA adjuvant platform has also exhibited a safety profile while tried in multiple clinical trials of Yisheng's rabies vaccine.
The Phase I clinical study is being conducted as a randomised, double blind, active-controlled, dose escalation study conducted at the Singapore General Hospital (SGH) and Changi General Hospital (CGH) in Singapore to test the safety, tolerability and immunogenicity of the investigational PIKA hepatitis B vaccine.
The trial enrolled 32 healthy volunteers and results suggested safety and tolerability of the hepatitis B vaccine.
Overseeing the clinical programme in Singapore, Dr Zhongkai Shi said: "PIKA's potent anti-viral and robust immune-stimulating capability makes PIKA platform well suited for the development of both preventive and therapeutic vaccine against the hepatitis B virus.
“Such encouraging data is setting up a good foundation to initiate a Phase II clinical study with an expanded study population and to further evaluate the clinical safety, immunogenicity and efficacy of the investigational vaccine.”