Clinical Trial of PCV24 in Adults Aged ≥18 Years

NCT07543198
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Phase
Phase 1/Phase 2
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Recruitment status
Completed
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Participants
385
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Start date
2025-06-18
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Number of sites
1
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Summary
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.
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Short title
Clinical Trial of PCV24 in Adults Aged ≥18 Years
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Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2026-02-26
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First posted
2026-04-21
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Registry last updated
2026-04-21
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Primary completion date
2026-02-26
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Start date
2025-06-18
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Actual participants
385
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Participants
385
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07543198
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ClinicalTrials.gov ID
NCT07543198
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Incidence of adverse reactions

    Timeframe: 0-30 days after vaccination

    Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination

  2. Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMT) (phase II)

    Timeframe: 30 days after vaccination

    OPA GMT 30 days after vaccination

  3. Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4-fold(phase II)

    Timeframe: 30 days after vaccination

    Proportion of OPA antibody titer increase≥four folds 30 days after vaccination

  4. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(phase II)

    Timeframe: 30 days after vaccination

    IgG GMC 30 days after vaccination

  5. Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4-fold(phase II)

    Timeframe: 30 days after vaccination

    Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination

  1. Incidence of clinically significant abnormality in laboratory examination tests(phase Ib)

    Timeframe: 0-3 days after vaccination

    Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination

  2. Incidence of adverse reactions

    Timeframe: 0-7 days after vaccination

    Incidence of adverse reactions within 7 days after vaccination

  3. Incidence of serious adverse reactions(SAE)

    Timeframe: 0-6 months after vaccination

    Incidence of SAE within 6 months after vaccination

  4. Pneumococcal serotype-specific OPA GMI(phase II)

    Timeframe: 30 days after vaccination

    OPA GMI 30 days after vaccination

  5. Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(phase II)

    Timeframe: 30 days after vaccination

    IgG GMI 30 days after vaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  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

  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.
Sources for eligibility
clinicaltrials.gov

  • Shaanxi Provincial Center for Disease Control and PreventionXi'an, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)