Evaluation of the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in Individuals Aged 18 Years and Above: A Random PhaseⅠClinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To evaluate The incidence of adverse reactions after vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Age and Identification: Volunteers aged ≥18 years on the screening day, able to provide valid legal identification.
- •2.Informed Consent: Volunteers who have received and understood the study information, voluntarily agreed to participate, and signed the Informed Consent Form.
- •3.Compliance: Volunteers able and willing to adhere to the clinical trial protocol requirements and attend all scheduled visits.
- •4.Baseline Temperature: Axillary temperature ≤37.0°C on the enrollment day.
排除标准
- •5.Vaccination History: Prior receipt of pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine within the past 3 years; or a history of invasive Streptococcus pneumoniae disease.
- •6.Severe Allergic Reactions: History of severe allergic reactions, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction), etc.
- •7.Immunocompromised Status: Diagnosed congenital or acquired immunodeficiency; or receipt of systemic glucocorticoid therapy (e.g., prednisone or equivalent >5 mg/day for ≥2 consecutive weeks) within 1 month prior to vaccination (local, inhaled, or nebulized steroids are permitted).
- •8.Severe Cardiovascular Diseases: History of arrhythmia, conduction block, myocardial infarction, or uncontrolled severe hypertension (on-site measurement: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
- •9.Acute Illness or Medication Use: Acute febrile illness, acute infectious disease, active cold symptoms, progressive influenza, or current use of related therapeutic medications.
- •10.Neurological/Developmental Disorders: History of neurological impairment, severe congenital malformation, severe developmental disorder, severe genetic defect, or severe malnutrition.
- •11.Neuropsychiatric History: Personal or family history of epilepsy, encephalopathy, or psychiatric disorders.
- •12.Coagulation Abnormalities: Diagnosed thrombocytopenia, coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disorders, platelet abnormalities), or contraindications to intramuscular injection (e.g., anticoagulant therapy).
- •13.Splenic Abnormalities: Asplenia, functional asplenia, or splenectomy for any reason.
- •14.Uncontrolled Chronic Diseases: Severe chronic diseases or progressive conditions that cannot be stably controlled.
- •15.Blood Products/Immunoglobulins: Receipt of blood or blood products, or immunoglobulins within the past 3 months.
- •16.Live Attenuated Vaccines: Vaccination with live attenuated vaccines within the past 14 days.
- •17.Other Vaccines: Vaccination with other vaccines within the past 7 days. 18.Investigational Products: Receipt of other investigational drugs or vaccines within the past 1 month.
- •19.Concurrent Studies: Current participation or planned participation in another clinical study of drugs or vaccines during the research period.
- •20.Investigator's Discretion: Any other condition that, in the investigator's judgment, may interfere with study evaluation.
- •21.Additional Exclusions for Specific Populations: Females of Childbearing Potential (18-49 years): Positive urine pregnancy test on enrollment day; lactation; or planning to become pregnant within 6 months.
研究组 & 干预措施
Low-dose group
Adults receive one dose of 0.5ml low-dose PCV24 vaccine.
干预措施: low dose PCV24 (Biological)
High-dose group.
Adults receive one dose of 0.5ml high-dose PCV24 vaccine.
干预措施: high dose PCV24 (Biological)
Positive control group
Adults receive one dose of 0.5ml PPV23 vaccine.
干预措施: PPV23 (Biological)
placebo control group
Adults receive one dose of 0.5ml normal saline.
干预措施: Placebo (Biological)
结局指标
主要结局
To evaluate The incidence of adverse reactions after vaccination
时间窗: Within 0-7 days after vaccination
The proportion of subjects reporting adverse reactions within 7 days after vaccination
次要结局
- Number of participants with clinically significant changes in urinalysis after vaccination(Day 3 after vaccination)
- To evaluate The incidenceof adverse events after vaccination.(Within 0-30 days after vaccination)
- To evaluate The occurrence of serious adverse events after vaccination.(Within 6 months after vaccination)
- Number of participants with clinically significant changes in blood routine after vaccination(Day 3 after vaccination)
- Number of participants with clinically significant changes in blood biochemistry after vaccination(Day 3 after vaccination)
- Number of participants with clinically significant changes in coagulation function after vaccination(Day 3 after vaccination)