PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
NCT ID: NCT07025876
Last Updated: 2025-06-18
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
240 participants
INTERVENTIONAL
2023-11-18
2024-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low-dose group
Adults receive one dose of 0.5ml low-dose PCV24 vaccine.
low dose PCV24
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).
High-dose group.
Adults receive one dose of 0.5ml high-dose PCV24 vaccine.
high dose PCV24
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).
Positive control group
Adults receive one dose of 0.5ml PPV23 vaccine.
PPV23
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.
placebo control group
Adults receive one dose of 0.5ml normal saline.
Placebo
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.
Interventions
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low dose PCV24
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).
high dose PCV24
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).
PPV23
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Locations
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Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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JSVCT182
Identifier Type: -
Identifier Source: org_study_id
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