Clinical Trial of PCV24 in Adults

NCT06474377 | Completed Phase 1

• 1 other identifier: PRO-PCV24-1001
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled Phase I clinical trial.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Incidence of adverse reactions within 30 days after vaccination

  0-30 days after vaccination

Secondary Outcomes (9)

• Incidence of adverse reactions

  0-7 days after vaccination

• Incidence of serious adverse events (SAE)

  0-6 months after vaccination

• Incidence of clinically significant abnormality in laboratory examination tests

  0-3 days after vaccination

• Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)

  30 days after vaccination

• Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)

  30 days after vaccination

Study Arms (4)

Experimental: Sinovac PCV24 formulation 1

EXPERIMENTAL

48 participants will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Sinovac PCV24 formulation 1

Experimental: Sinovac PCV24 formulation 2

EXPERIMENTAL

48 participants will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Sinovac PCV24 formulation 2

Active control: Pneumovax®

ACTIVE COMPARATOR

48 participants will be randomized to receive Pneumovax®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Pneumovax®

Placebo: Normal saline

PLACEBO COMPARATOR

24 participants will be randomized to receive placebo. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Placebo

Interventions

Sinovac PCV24 formulation 1 BIOLOGICAL

One dose of Sinovac PCV24 formulation 1（0.5mL）

Experimental: Sinovac PCV24 formulation 1

Sinovac PCV24 formulation 2 BIOLOGICAL

One dose of Sinovac PCV24 formulation 2（0.5mL）

Experimental: Sinovac PCV24 formulation 2

Pneumovax® BIOLOGICAL

One dose of Pneumovax® (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 and 33F saccharides.

Active control: Pneumovax®

Placebo BIOLOGICAL

0.5 mL of 0.9%NaCl solution (normal saline)

Placebo: Normal saline

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers who are aged 18 years and older, and provide legal proof of identity;
• Participants understand and voluntarily sign the informed consent form;
• Participants can follow all study procedures and stay in contact during the study.

You may not qualify if:

• Received any pneumococcal vaccine prior to enrollment;
• History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
• History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
• Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
• Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as hypertension uncontrolled by drugs (measurement on site: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) and coronary heart disease, metabolic diseases (such as uncontrolled diabetes), hematological diseases (e.g. severe anemia, hemophilia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
• Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
• Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
• Long-term alcohol or drug abuse.
• Have received \> 14 days of immunosuppressive or other immunomodulatory therapy (such as prednisone ≥20 mg/ day, or its equivalent) in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period.
• Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period;
• Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
• Received live attenuated vaccine within 14 days prior to enrollment;
• Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
• Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Kai Chu

  Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 21, 2024
• Primary Completion: August 26, 2024
• Study Completion: February 26, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)