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HBV vaccine candidate exhibits tolerability in dose escalation trial

Yisheng Biopharma Co., Ltd. announced its hepatitis B vaccine candidate administered with its PIKA adjunct technology demonstrated tolerability and safety in a phase 1 dose escalation clinical trial.

The proprietary PIKA adjuvant technology uses its own toll-like receptor-3 (TLR-3) agonist molecules to activate the innate immune cells. It is formulated as a component of PIKA-adjuvant based hepatitis vaccine, according to a press release.

In the trial, 32 healthy volunteers received the PIKA hepatitis B vaccine in a three-dose vaccine at Singapore General Hospital and Changi General Hospital, Singapore, as opposed to three-dose vaccination of the standard licensed products. They completed the vaccine dosage within 2 months compared with the standard 6 months. It was both safe and tolerable among the patients, according to the release.

“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 hepatitis B virus. Such encouraging data is setting up good foundation to initiate a phase 2 clinical study with expanded study population and to further evaluate the clinical safety, immunogenicity and efficacy of the investigational vaccine,” Zhongkai Shi, who is overseeing the clinical program in Singapore, said in the release. “We are pleased with the results of this study in which PIKA hepatitis B vaccine exhibited good safety and tolerability. We are also encouraged by the observation of the robust immunogenicity among the human subjects immunized with the PIKA hepatitis B vaccine.”