Aimei Vaccine has initiated phase III clinical trials of a 23-valent pneumococcal polysaccharide vaccine

2023-08-30 Source:Aimbio
According to Aimei Vaccine (06660), the company announced that on August 28, 2023, a randomized, double-blind, controlled trial of a 23-valent pneumococcal polysaccharide vaccine phase III was initiated at the disease control center of a southern county in Sichuan Province. This research will be conducted at two sites in Sichuan Province and one site in Shandong Province, planning to enroll 1,920 healthy subjects aged 2 or above.

It is reported that the phase I clinical trial of this 23-valent pneumococcal polysaccharide vaccine was initiated in December 2021 at the disease control center of a southern county in Sichuan Province. As of now, safety and immunogenicity analyses have shown good safety and good immunogenicity for this product.

This 23-valent pneumococcal polysaccharide vaccine is suitable for the prevention of invasive pneumococcal diseases in people aged 2 and above, especially in the elderly over 60. The vaccine contains 23 pneumococcal serotype polysaccharide antigens, which can prevent pneumonia, meningitis, otitis media, bacteremia, etc., caused by pneumococcal infections, covering nearly 90% of the reported serotypes causing pneumococcal diseases.

From the semi-annual report, it has been learned that the company is expected to make significant progress in vaccine research and development in 2023. The company's R&D pipeline includes 23 vaccines targeting 14 disease areas, with nine varieties already obtaining 14 clinical approvals.

Among them, the heavyweight product, the 13-valent pneumococcal conjugate vaccine (PCV13), has completed phase III clinical full-course inoculation and blood collection. The 23-valent pneumococcal polysaccharide vaccine (PPSV23) has initiated phase III clinical trials. The freeze-dried human rabies vaccine (serum-free Vero cell) obtained clinical approval in October 2022 and started phase III clinical trials in July 2023. Additionally, the A, C, Y, and W135 group meningococcal conjugate vaccine (commonly known as quadrivalent conjugated meningococcal vaccine) started phase I clinical trials in February 2023 and is expected to start phase III clinical trials in 2024. Overseas phase III clinical trials for the bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine are in the final stages, and the bivalent EV71-CA16 hand, foot, and mouth disease vaccine (human diploid cell) has entered clinical trials.

Furthermore, the supporting production capacity construction has been completed. Production bases for pneumococcal vaccines, serum-free Vero cell rabies vaccines, human diploid cell rabies vaccines, and meningococcal vaccines have all been established. Clinical samples related to new products are being produced at the production base to accelerate the pace of new product launches. The launch of new products has entered the sprint stage.