Clinical Trial of PCV24 in Adults

NCT06474377
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Phase
Phase 1
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Recruitment status
Completed
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Participants
170
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Start date
2024-06-21
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Number of sites
1
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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.
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Short title
Clinical Trial of PCV24 in Adults
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Official title
A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older
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Control arm
Placebo
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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
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Study type
Interventional
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Completion date
2025-02-26
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First posted
2024-06-25
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Registry last updated
2025-04-16
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Primary completion date
2024-08-26
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Start date
2024-06-21
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Actual participants
170
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Participants
170
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
2:2:2:1
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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
NCT06474377
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ClinicalTrials.gov ID
NCT06474377
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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 within 30 days after vaccination

  1. Incidence of adverse reactions

    Timeframe: 0-7 days after vaccination

    Incidence of adverse reactions within 7 days after vaccination

  2. Incidence of serious adverse events (SAE)

    Timeframe: 0-6 months after vaccination

    Incidence of SAE during the period of safety monitoring

  3. Incidence of clinically significant abnormality in laboratory examination tests

    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

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

    Timeframe: 30 days after vaccination

    IgG GMC 30 days after vaccination

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

    Timeframe: 30 days after vaccination

    IgG GMI 30 days after vaccination

  6. Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4

    Timeframe: 30 days after vaccination

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

  7. Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs)

    Timeframe: 30 days after vaccination

    OPA GMT 30 days after vaccination

  8. Pneumococcal serotype-specific OPA GMI

    Timeframe: 30 days after vaccination

    OPA GMI 30 days after vaccination

  9. Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4

    Timeframe: 30 days after vaccination

    Proportion of OPA antibody titer increase≥four folds 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 volunteers who are aged 18 years and older, and provide legal proof of identity;
  2. Participants understand and voluntarily sign the informed consent form;
  3. Participants can follow all study procedures and stay in contact during the study.

  1. Received any pneumococcal vaccine prior to enrollment;
  2. History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
  3. History of allergy or 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 (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
  5. 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;
  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. 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.
  8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) 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 its equivalent) 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 prior to enrollment, or plan to receive such treatment during the study period;
  12. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
  13. Received live attenuated vaccine within 14 days prior to enrollment;
  14. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
  15. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;
  16. Women who are breastfeeding;
  17. Fertile women aged 18-59 years who plan to become pregnant or cannot use effective contraception or have egg donation plans from enrollment to 3 months after the study intervention;
  18. Women who are pregnant (as judged by the participant's blood pregnancy test);
  19. Had fever (axillary temperature> 37.0℃) before vaccination;
  20. Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
  21. 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

  • Jiangsu Provincial Center for Disease Control and PreventionNanjing, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)