According to Zhu Xianchao, the founder and CEO of Reinovax Biologics, the Phase II clinical trial is a randomized, double-blind, and parallel-controlled study with 992 participants to evaluate the safety and immunogenicity of the vaccine in people aged 18 and above. It was reported that the Phase I clinical trial of the project met its primary endpoint with the safety profile comparable with the marketed comparator vaccine. The most common vaccine-related adverse reactions are redness, swelling, heat, and pain in the local injection site as expected.

The expert committee of DSMB (Data Safety Monitoring Board) unanimously agreed that the project can proceed to the Phase II clinical trial.

Streptococcus pneumoniae is a major pathogen causing acute respiratory infection especially in infants and the elderly. It can not only cause pneumonia but also lead to tracheitis, otitis media, sinusitis, meningitis, bacteremia, and other diseases. According to WHO estimation, in 2008, about 8.8 million children under the age of 5 died, with approximately 476,000 of those deaths due to pneumococcal infections, and the incidence and mortality of pneumococcal infections in developing countries are much higher than in industrialized nations. WHO has prioritized the global vaccination against pneumococcal infections to prevent diseases caused by Streptococcus pneumoniae.

It is understood that there are more than 90 serotypes of Streptococcus pneumoniae, but the prevalence of S. pneumoniae causing invasive infections are found among dozens of serotypes. Currently, there are two types of pneumococcal vaccines available in the domestic market: the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23).

24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) solely developed by Reinovax Biologics covers all serotypes of Streptococcus pneumoniae currently approved on the market. With the implementation of the conjugation technology as well as novel carrier protein, this vaccine can effectively enhance the immunogenicity against all 24 serotypes of pneumococci and induce good immunological memory. The Phase II clinical trial will be carried out with a single vaccination in adults and elderly people aged 18 and above, further evaluating the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine.