YishengBio has received approval from the United Arab Emirates (UAE) and the Philippines regulatory authorities for conducting Phase II/III clinical trials for its PIKA recombinant Covid-19 vaccine.
Designed to be multi-country and multi-centre, these trials will assess the safety, efficacy, and immunogenicity of the vaccine as a booster injection in subjects who were given two or more inactivated Covid-19 vaccine doses.
The trial will enrol 9,300 subjects in the UAE, the Philippines, and Pakistan.
The recombinant Covid-19 vaccine comprises PIKA adjuvant and S protein antigens and has potential prophylactic and therapeutic benefits against the infection.
In pre-clinical studies, the vaccine showed to be capable of sustaining two year-long high neutralising antibody levels against a broad range of the Covid-19 virus variants, including Omicron BA.2, BA.4/5.
YishengBio chairman and project leader Yi Zhang said: “The initiation of the phase II/III clinical trials in multi countries will accelerate the clinical development of PIKA recombinant Covid-19 vaccine candidate to a new level.
“This vaccine candidate has the potential to become a universal vaccine against the swiftly mutating SARS-CoV-2 virus worldwide.
“Equally important, our newly constructed manufacturing plant dedicated to the commercialisation of PIKA recombinant Covid-19 vaccine was recently granted the drug manufacturing certificate by the China’s National Medical Products Administration (NMPA).”
Interim data from the Phase I trial the of PIKA Covid-19 vaccine in the UAE showed that subjects who received a low dose of 5ug per injection attained high neutralising antibody levels against all variants of the SARS-CoV-2 virus in the prime vaccination regimen, and in booster doses.
These subjects completed two inactivated vaccine doses.
In Phase I clinical trials, the vaccine showed a good safety profile.
