Clinical Trial of PCV24 in Adults Aged ≥18 Years

A Randomized, Double-blind, Positive Controlled Phase Ib/II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years

A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years.

The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, Positive Controlled phase Ib/II clinical trial.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infectious Disease
• Intervention / Treatment: Biological: Sinovac Low-dosage PCV24; Biological: Sinovac Middle-dosage PCV24; Biological: Sinovac High-dosage PCV24; Biological: Pneumovax®

Detailed Description

A phase Ib/II clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese adults aged ≥18years.

The trial is a randomized, double-blind, positive controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Pneumovax® manufactured by MSD.

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Shaanxi Provincial 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. Healthy adults aged ≥18 years, who can provide legal identification documents
2. Fully understand and agree to sign the informed consent form
3. Willing and able to follow all study procedures and stay in contact during the study

Exclusion Criteria:

1. Received any pneumococcal vaccine;
2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
3. History of allergy or serious adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
4. Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
5. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases,liver and kidney diseases, digestive diseases, respiratory diseases , malignant tumors and major functional organ transplantation history;
6. Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis,autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
7. Abnormalities in coagulation function (such as deficiency of coagulation factors, coagulation disorders, and abnormalities of platelets);
8. Have/have suffered from a serious neurological disorder (epilepsy , convulsions or seizures) or mental illness or have a family history of such diseases;
9. Long-term alcohol or drug abuse;
10. Have received > 14 days of immunosuppressive or other immunomodulatory therapy((such as prednisone ≥20 mg/day, or an equivalent dose)) in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period;
11. Received immunoglobulin or other blood products within 3 months before receiving the l vaccine, or plan to receive such treatment during the study period;
12. Received other investigational drugs or vaccines within 30 days before receiving the vaccine, or plan to receive such drugs or vaccines during the study;
13. Received live attenuated vaccine within 14 days before receiving the vaccine;
14. Received subunit or inactivated or other vaccine within 7 days before receiving the vaccine;
15. Acute diseases or acute onset of chronic diseases within the past 7 days , or known or suspected active infection;
16. Women who are breastfeeding or pregnant, or women of childbearing potential who plan to become pregnant or have egg donation plans from the time of signing the informed consent form until 6 months after the study intervention;
17. Participants who have a fever on the day of the planned trial vaccine, with an axillary temperature >37.0°C before vaccination;
18. Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant(Applicable only to phase Ib)
19. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dosage PCV24 (phase Ib); 12 Participants aged 18-49years and 12 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Sinovac Low-dosage PCV24; One dose of Sinovac Low-dosage PCV24 (0.5mL)
Experimental: Middle-dosage PCV24(phase Ib); 12 Participants aged 18-49 years and 12 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Sinovac Middle-dosage PCV24; One dose of Sinovac Middle-dosage PCV24(0.5mL)
Experimental: High-dosage PCV24(phase Ib); 12 Participants aged 18-49years will receive Sinovac High-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Sinovac High-dosage PCV24; One dose of Sinovac High-dosage PCV24(0.5mL)
Active Comparator: Pneumovax®(phase Ib); 12 Participants aged 18-49years and 6 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Pneumovax®; One dose of PPV23 manufactured by MSD
Experimental: Low-dosage PCV24(phase II); 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Sinovac Low-dosage PCV24; One dose of Sinovac Low-dosage PCV24 (0.5mL)
Experimental: Middle-dosage PCV24(phase II); 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Sinovac Middle-dosage PCV24; One dose of Sinovac Middle-dosage PCV24(0.5mL)
Active Comparator: Pneumovax®(phase II); 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose	Biological: Pneumovax®; One dose of PPV23 manufactured by MSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination	0-30 days after vaccination
Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMT) (phase II)	OPA GMT 30 days after vaccination	30 days after vaccination
Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4-fold(phase II)	Proportion of OPA antibody titer increase≥four folds 30 days after vaccination	30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(phase II)	IgG GMC 30 days after vaccination	30 days after vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4-fold(phase II)	Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination	30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	Incidence of adverse reactions within 7 days after vaccination	0-7 days after vaccination
Incidence of clinically significant abnormality in laboratory examination tests(phase Ib)	Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination	0-3 days after vaccination
Incidence of serious adverse reactions(SAE)	Incidence of SAE within 6 months after vaccination	0-6 months after vaccination
Pneumococcal serotype-specific OPA GMI(phase II)	OPA GMI 30 days after vaccination	30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(phase II)	IgG GMI 30 days after vaccination	30 days after vaccination

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.
• Investigators: Principal Investigator: Weijun Hu, Shaanxi Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Actual): February 26, 2026
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

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; Biological Products; Complex Mixtures; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Pneumococcal Vaccines
• Other Study ID Numbers: PRO-PCV24-1004

Drug and device information, study documents

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