CanSino Biologics completed the first subject enrollment in Phase I clinical trial of its component diphtheria-tetanus and pertussis combined vaccine for adolescents and adults

December 14, 2023  Source: drugdu 124

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Recently, CanSino Biologics' adsorbed acellular (component) diphtheria-tetanus combination vaccine (hereinafter referred to as "Tdcp for adolescents and adults") officially launched Phase I clinical trials and completed the enrollment of the first subject.

Tdcp for adolescents and adults is suitable for people aged 6 years and above. It is a booster vaccine for adolescents and adults. This randomized, blinded, controlled phase I clinical trial will initially evaluate the safety and immunogenicity of the vaccine.

Whooping cough, diphtheria and tetanus, also known as diphtheria, are serious diseases caused by bacteria. Since the protective effect of immunity triggered by the main antigen of pertussis gradually decreases after vaccination, the incidence and mortality of pertussis gradually increase in the post-vaccination population. The domestic market is in urgent need of a DPT vaccine with longer-lasting immune protection and higher safety.

Major developed countries have included this vaccine in their regular vaccination plans, but there is no approved DPT booster vaccine for adolescents and adults in China. If this product is successfully launched, it will fill a gap in the domestic market.

The manufacturing process of the co-purified DPT vaccine currently sold in China uses the process of co-purifying the pertussis antigen. CanSino Biological's Tdcp-based diphtheria pertussis vaccine for adolescents and adults. Each pertussis antigen can be purified separately and formulated in a determined ratio, thereby ensuring batch-to-batch consistency of product quality, making the product quality more stable, and laying the foundation for subsequent research and development. An important foundation has been laid for production and commercialization.

Relying on the advantages of advanced technology platforms, CanSino Biologics has successfully established a series of product pipelines for component DPT, which will further enrich the company's product strategy and enhance the company's core competitiveness.

CanSino Biologics' component-based DPT vaccine product portfolio includes component-based DPT vaccine for infants and young children, component-based DPT vaccine for adolescents and adults, and combination vaccines based on component-based DPT vaccine. Among them, the component diphtheria-tetanus vaccine for infants and young children is in phase III clinical trials.

CanSino Biologics will accelerate its research pipeline into the clinical stage, actively expand new business models, fulfill its commitment to provide innovative, high-quality, and accessible vaccines to the world, and contribute China's strength to human health.

https://www.cansinotech.com.cn/html/1///179/180/2315.html

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