Phase Ⅱ Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
China992 participantsStarted 2024-04-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓.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.
Exclusion criteria
✕.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.
What they're measuring
1
To evaluate the immunogenicity after vaccination
Timeframe: Within 30 days after vaccination
Trial details
NCT IDNCT07035054
SponsorJiangsu Province Centers for Disease Control and Prevention
✕0.Neurological/Developmental Disorders: History of neurological impairment, severe congenital malformation, severe developmental disorder, severe genetic defect, or severe malnutrition.
✕1.Neuropsychiatric History: Personal or family history of epilepsy, encephalopathy, or psychiatric disorders.