A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)

NCT06056050
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Phase
Phase 1
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Recruitment status
Completed
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Participants
180
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Lead sponsor
CanSino Biologics Inc.
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Start date
2023-12-06
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Number of sites
1
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Summary
Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.
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Short title
A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)
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Official title
A Randomized, Blinded, Controlled Phase I Clinical Trial for Preliminary Evaluation of the Safety and Immunogenicity of Adsorbed Cell-free DPT Vaccine (for People Aged 6 Years and Above)
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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
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Study type
Interventional
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Completion date
2025-03-11
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First posted
2023-09-28
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Registry last updated
2026-08-07
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Primary completion date
2024-04-13
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Start date
2023-12-06
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Actual participants
180
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Participants
180
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Participant count basis
Actual
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Protocol amendments
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
CanSino Biologics Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06056050
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ClinicalTrials.gov ID
NCT06056050
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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 0-30 days after vaccination

    Timeframe: 0-30 days after vaccination

  1. Incidence of adverse reactions within 30 minutes of vaccination

    Timeframe: Within 30 minutes of vaccination

  2. Incidence of adverse reactions/adverse events 0-7 days after vaccination

    Timeframe: 0-7 days after vaccination

  3. Incidence of adverse events 0-30 days after vaccination

    Timeframe: 0-30 days after vaccination

  4. Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group

    Timeframe: 360 days after vaccination

  5. Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group

    Timeframe: 180 days after vaccination

  6. Hemoglobin content (HGB) on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  7. White blood cell count on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  8. Alanine aminotransferase (ALT) in blood on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  9. Aspartate aminotransferase (AST) in blood on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  10. Total bilirubin (TBIL) in blood on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  11. Protein in urine on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  12. Erythrocytes in urine on day 4 after vaccination

    Timeframe: Day 4 after vaccination

  13. Antibody Positive Turnover of Serum Anti-Diphtheria Toxoid(DT), Tetanus Toxoid(TT), Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), FIM bridal agglutinogens(FIM) 2&3 at 30 days after vaccination

    Timeframe: 30 days after vaccination

  14. Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination

    Timeframe: 30 days after vaccination

  15. Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination

    Timeframe: 30 days after vaccination

  16. Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination

    Timeframe: 30 days after vaccination

Sources for outcomes
clinicaltrials.gov

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

  • ≥ 6 years of age.
  • Willingness to provide proof of identity.
  • The informed consent of the volunteer and/or the guardian and/or the delegate must be obtained and the informed consent form must be signed.
  • Volunteers are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up.
  • Volunteers aged 6-11 years who have completed 4 doses of DPT-containing vaccine, but have not received the 5th dose, and have ≥3 years between the 4th dose.
  • Volunteers aged ≥12 years must not have received any of the components of the DPT-containing vaccine within 5 years.

  • Persons with fever prior to vaccination, with axillary temperature > 37.0°C.
  • A female with a positive urine pregnancy test or a breastfeeding volunteer, where the volunteer or her partner has a plan to become pregnant within 180 days.
  • Adults with severe cardiovascular disease, hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication, or other severe chronic diseases.
  • Abnormal and clinically significant results of preimmunization blood tests, blood biochemistry and urine tests.
  • Persons who have suffered from one of the diseases of diphtheria or tetanus, or who have suffered from whooping cough in the last three years.
  • Volunteers ≥12 years of age who have received pneumococcal polysaccharide/conjugate-containing vaccine within 4 years.
  • Individuals who have had household contact with individuals diagnosed with pertussis, diphtheria, tetanus in the past 30 days.
  • Individuals who are allergic to the components of the study vaccine or who have developed an allergy during previous administration of the same vaccine; individuals with a previous history of severe allergies, such as urticaria, anaphylaxis, respiratory distress, angioneurotic edema, or asthma.
  • History of convulsions, epilepsy, encephalopathy and serious neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.), etc.
  • Individuals with primary and secondary immune impairment (history of thyroid, pancreas, liver, spleen, kidney disease or removal, or need for treatment due to thyroid disease within the past 12 months), who have received immunosuppressive therapy within 3 months.
  • Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders.
  • Persons with acute febrile illnesses and current patients with infectious diseases who have had a history of moderately high fever (axillary temperature ≥38.0°C) or cardiopulmonary disease (frequent asthma attacks) within the past 3 days.
  • Has received another investigational drug or vaccine within 1 month prior to receiving the experimental drug, or is planning to participate or is participating in a clinical study of any other drug.
  • Received live attenuated vaccine within 14 days prior to receiving the test drug and subunit vaccine or inactivated vaccine within 7 days prior to receiving the test drug.
  • Any other factors that, in the judgment of the investigator, make the volunteer unsuitable for participation in a clinical trial.
Sources for eligibility
clinicaltrials.gov

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

Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (3)