Evaluation of a new 24-valent pneumococcal vaccine in adults

A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

This study is testing a new 24-valent pneumococcal vaccine to see if it is safe and works better than the current vaccine in adults aged 18 and older.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 992 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Reinovax Biologics Co.,LTD (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 2 sites (Pizhou, Jiangsu and 1 other locations)
• Trial ID: NCT06678620 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial aims to assess the safety and immunogenicity of a 24-valent pneumococcal conjugate vaccine (PCV24) in Chinese adults aged 18 years and older. The study will enroll at least 992 participants, who will be randomized to receive one of three formulations of PCV24 or a standard 23-valent pneumococcal polysaccharide vaccine (PPSV23). The trial is designed as a single-center, randomized, blinded, parallel-controlled, non-inferiority study, comparing the new vaccine's effectiveness against the established vaccine. Participants will be monitored for safety and immune response following vaccination.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 years and older who have not received pneumococcal vaccines in the past three years.

Not a fit: Patients with a history of severe allergies or immunodeficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide enhanced protection against pneumococcal infections for adults, particularly the elderly.

How similar studies have performed: Other studies have shown success with pneumococcal vaccines, but this specific 24-valent formulation is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Volunteers aged 18 and above on the day of screening, and can provide legal identification;
2. Informed consent must be obtained from the volunteer and signed informed consent form;
3. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
4. Armpit body temperature ≤ 37.0 °C on the day of enrollment.

   Exclusion Criteria:
5. Previous vaccination with pneumococcal conjugate vaccine, prior vaccination with pneumococcal polysaccharide vaccine for less than 3 years, or previous history of invasive disease caused by Streptococcus pneumoniae;
6. Have any history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
7. Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs \>5 mg/day for more than 2 consecutive weeks in 1 month prior to vaccination);
8. Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when measured on site);
9. Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication;
10. History of nervous system damage, severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;
11. Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders;
12. Those who have been diagnosed with thrombocytopenia, any abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities, etc.) or contraindications to intramuscular injection such as anticoagulant therapy;
13. asplenia, functional asplenia, and asplenia or splenectomy due to any cause;
14. Suffering from severe chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly;
15. Have received blood or blood-related products or immunoglobulins within 3 months;
16. Received live attenuated vaccine within 14 days;
17. Other vaccinations within 7 days;
18. Received other investigational drugs or vaccines within 1 month;
19. Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period;
20. Any other condition that, in the opinion of the investigator, may interfere with the study evaluation;
21. Exclusion Criteria for Partial Populations:

Females of childbearing potential (18\~49 years old): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months.

Where this trial is running

Pizhou, Jiangsu and 1 other locations

• Pizhou Center for Disease Control and Prevention — Pizhou, Jiangsu, China (Recruiting)
• Xuzhou Center for Disease Control and Prevention — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Hongxing Pan, Master

Conditions Pneumococcal Infectious Disease