PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT07025876 | Completed Early Phase 1

• 1 other identifier: JSVCT182
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Streptococcus Pneumoniae Pneumonia

Outcome Measures

Primary Outcomes (1)

• To evaluate The incidence of adverse reactions after vaccination

  The proportion of subjects reporting adverse reactions within 7 days after vaccination

  Within 0-7 days after vaccination

Secondary Outcomes (6)

• 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

Study Arms (4)

Low-dose group

EXPERIMENTAL

Adults receive one dose of 0.5ml low-dose PCV24 vaccine.

Biological: low dose PCV24

High-dose group.

EXPERIMENTAL

Adults receive one dose of 0.5ml high-dose PCV24 vaccine.

Biological: high dose PCV24

Positive control group

ACTIVE COMPARATOR

Adults receive one dose of 0.5ml PPV23 vaccine.

Biological: PPV23

placebo control group

PLACEBO COMPARATOR

Adults receive one dose of 0.5ml normal saline.

Biological: Placebo

Interventions

low dose PCV24 BIOLOGICAL

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).

Low-dose group

high dose PCV24 BIOLOGICAL

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).

High-dose group.

PPV23 BIOLOGICAL

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.

Positive control group

Placebo BIOLOGICAL

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.

placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and Identification: Volunteers aged ≥18 years on the screening day, able to provide valid legal identification.
• Informed Consent: Volunteers who have received and understood the study information, voluntarily agreed to participate, and signed the Informed Consent Form.
• Compliance: Volunteers able and willing to adhere to the clinical trial protocol requirements and attend all scheduled visits.
• Baseline Temperature: Axillary temperature ≤37.0°C on the enrollment day.

You may not qualify if:

• Vaccination History: Prior receipt of pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine within the past 3 years; or a history of invasive Streptococcus pneumoniae disease.
• 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.
• 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).
• 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).
• Acute Illness or Medication Use: Acute febrile illness, acute infectious disease, active cold symptoms, progressive influenza, or current use of related therapeutic medications.
• Neurological/Developmental Disorders: History of neurological impairment, severe congenital malformation, severe developmental disorder, severe genetic defect, or severe malnutrition.
• Neuropsychiatric History: Personal or family history of epilepsy, encephalopathy, or psychiatric disorders.
• Coagulation Abnormalities: Diagnosed thrombocytopenia, coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disorders, platelet abnormalities), or contraindications to intramuscular injection (e.g., anticoagulant therapy).
• Splenic Abnormalities: Asplenia, functional asplenia, or splenectomy for any reason.
• Uncontrolled Chronic Diseases: Severe chronic diseases or progressive conditions that cannot be stably controlled.
• Blood Products/Immunoglobulins: Receipt of blood or blood products, or immunoglobulins within the past 3 months.
• Live Attenuated Vaccines: Vaccination with live attenuated vaccines within the past 14 days.
• 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.
• Concurrent Studies: Current participation or planned participation in another clinical study of drugs or vaccines during the research period.
• Investigator's Discretion: Any other condition that, in the investigator's judgment, may interfere with study evaluation.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 18, 2025
• Study Start: November 18, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 30, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)