In the treatment of pneumococcal diseases, the common use of penicillin-based antimicrobial agents has led to drug resistance, which has become a global challenge. Therefore, disease prevention through vaccination is essential. The 23-valent pneumococcal polysaccharide vaccine, the first widely used vaccine, has limitations. Subsequent pneumococcal polysaccharide conjugate vaccines have improved protection rates but increased cases of infections caused by non-vaccine serotype strains. Currently, vaccines available in China for pneumococcal disease prevention include the 23-valent polysaccharide vaccine (approved only for adults) and the 13-valent conjugate vaccine. PCV24 expands serotype coverage and converts capsular polysaccharides into T-cell-dependent antigens by binding them to proteins, stimulating humoral immunity and the complement system to generate specific antibodies and immunological memory for disease prevention. This study aims to preliminarily investigate the safety and immunogenicity of PCV24 vaccination in Chinese adults.
Streptococcus pneumoniae is a Gram-positive diplococcus, and its capsular polysaccharide is a key virulence factor. According to differences in the composition and structure of capsular polysaccharides, it can be divided into more than 90 serotypes, with varying viability and pathogenicity among different serotypes. As an important opportunistic pathogen, this bacterium can breach mucosal defense systems to cause invasive infections when host immunity declines, leading to diseases such as pneumonia, bacterial meningitis, bacteremia, sinusitis, and otitis media. Antimicrobial agents commonly used in the treatment of pneumococcal diseases, such as penicillins, macrolides, and cephalosporins, have faced global challenges due to drug resistance, making vaccination essential for disease prevention. The World Health Organization (WHO) has classified pneumococcal diseases as a top priority for vaccination. The early widely used 23-valent pneumococcal polysaccharide vaccine had limitations, while subsequent 7-valent, 10-valent, and 13-valent pneumococcal polysaccharide conjugate vaccines improved protection rates but were associated with increased infections from non-vaccine serotype strains. Currently, only the 23-valent polysaccharide vaccine is approved for adult use in China. Pneumococcal conjugate vaccines convert capsular polysaccharides into T-cell-dependent antigens by binding them to proteins, thereby stimulating humoral immunity and the complement system to generate specific antibodies and immunological memory for disease prevention. This study aims to evaluate the safety and tolerability of a 24-valent pneumococcal polysaccharide conjugate vaccine in individuals aged 18 years and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
240
The 24-valent pneumococcal polysaccharide conjugate vaccine (low-dose) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, with a dosage of 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows: * 3 serotypes (3, 6B, 12F): 4.0 μg per vial each * 21 other serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F): 2.0 μg per vial each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose).
The 24-valent pneumococcal polysaccharide conjugate vaccine (high-dose) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, with a dosage of 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows: 3 serotypes (3, 6B, 12F): 8.0 μg per vial each 21 other serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F): 4.0 μg per vial each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose).
The 23-valent pneumococcal polysaccharide vaccine (PPV23) produced by Chengdu Institute of Biological Products is available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration. It contains the following pneumococcal polysaccharides for each serotype: Serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F: 25 μg per vial for each serotype. Additionally, it contains sodium chloride and water for injection.
In addition to the antigen components, the 24-valent pneumococcal polysaccharide conjugate vaccine developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. contains the following excipients: Aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose) Sodium chloride Succinic acid Polysorbate 80 Water for injection It is a liquid formulation, available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
To evaluate The incidence of adverse reactions after vaccination
The proportion of subjects reporting adverse reactions within 7 days after vaccination
Time frame: Within 0-7 days after vaccination
To evaluate The incidenceof adverse events after vaccination.
The proportion of subjects reporting adverse events within 0-30 days after vaccination.
Time frame: Within 0-30 days after vaccination
To evaluate The occurrence of serious adverse events after vaccination.
The proportion of subjects reporting serious adverse events after vaccination.
Time frame: Within 6 months after vaccination
Number of participants with clinically significant changes in blood routine after vaccination
Changes in blood routine indicators on day 3 after vaccination
Time frame: Day 3 after vaccination
Number of participants with clinically significant changes in blood biochemistry after vaccination
Measurement: Changes in blood biochemistry indicators on day 3 after vaccination
Time frame: Day 3 after vaccination
Number of participants with clinically significant changes in coagulation function after vaccination
Changes in coagulation function indicators on day 3 after vaccination
Time frame: Day 3 after vaccination
Number of participants with clinically significant changes in urinalysis after vaccination
Changes in urinalysis indicators on day 3 after vaccination
Time frame: Day 3 after vaccination
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