Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

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

A phase II clinical trial of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumococcal Infectious Disease
• Intervention / Treatment: Biological: Reinovax PCV24 formulation 1; Biological: Reinovax PCV24 formulation 2; Biological: Reinovax PCV24 formulation 3; Biological: PPSV23

Detailed Description

Phase II clinical trial of the 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products.

At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.

• Study Type: Interventional
• Enrollment (Estimated): 992
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Pizhou, Jiangsu, China
      • Pizhou Center for Disease Control and Prevention
    • Xuzhou, Jiangsu, China
      • Xuzhou Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group 1; 248 participants will be randomized to receive Reinovax PCV24 formulation 1. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.	Biological: Reinovax PCV24 formulation 1; One dose of Reinovax PCV24 formulation 1（0.5mL）
Experimental: Experimental group 2; 248 participants will be randomized to receive Reinovax PCV24 formulation 2. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.	Biological: Reinovax PCV24 formulation 2; One dose of Reinovax PCV24 formulation 1（0.5mL）
Experimental: Experimental group 3; 248 participants will be randomized to receive Reinovax PCV24 formulation 3. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.	Biological: Reinovax PCV24 formulation 3; One dose of Reinovax PCV24 formulation 1（0.5mL）
Active Comparator: Active control group; 248 participants will be randomized to receive PPSV23. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.	Biological: PPSV23; One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events (SAE)	Incidence of SAE during the period of safety monitoring	0-6 months after vaccination
incidence of adverse events	The incidence of adverse events within 30 days after vaccination.	0~30 days after vaccination
Positive conversion rate of specific IgG antibodies by serotype	The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group.	0~30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus	The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus in subjects 30 days after immunization in each group	0~30 days after vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the exploratory subgroup, the geometric mean concentration (GMT) of the pneumococcal vaccine was covered by multiplexed opsonophagocytic assay (MOPA)	In the exploratory subgroup, the geometric mean concentration (GMT) of the pneumococcal vaccine was covered by multiplexed opsonophagocytic assay (MOPA) 30 days before and 30 days after immunization.	0~30 days after vaccination
Exploratory subgroup, pneumococcal vaccine coverage of all serotypes/partial serotypes IgG and/or sIgA antibody levels in saliva	Exploratory subgroup, pneumococcal vaccine coverage of all serotypes/partial serotypes IgG and/or sIgA antibody levels in saliva before vaccination, 30 days, and 6 months after vaccination	before vaccination, 30 days, and 6 months after vaccination
Exploratory subgroup, pneumococcal colonization in the nasopharynx of subjects	Exploratory subgroup, pneumococcal colonization in the nasopharynx of subjects before vaccination, 30 days, and 6 months after vaccination.	before vaccination, 30 days, and 6 months after vaccination.

Collaborators and Investigators

• Sponsor: Shanghai Reinovax Biologics Co.,LTD

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Actual): April 21, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; 23-valent pneumococcal capsular polysaccharide vaccine
• Other Study ID Numbers: JSVCT183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No