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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
23-Valent Pneumococcal Polysaccharide Vaccine(PPV23)
Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Vaccine, Five Components, Immunogenicity, Safety, ≥6 years, Acellular

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ≥ 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. Exclusion Criteria: 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.

Sites / Locations

  • Shaanxi Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Experimental vaccine group 1A,≥18 years old

Control vaccine group 1B,≥18 years old

Experimental vaccine group 2A,12~17 years old

Control vaccine group 2B,12~17 years old

Experimental vaccine group 3A,6~11 years old

Control vaccine group 3B,6~11 years old

Arm Description

1 dose of Tdcp vaccine

1 dose of PPV23 vaccine

1 dose of Tdcp vaccine

1 dose of PPV23 vaccine

1 dose of Tdcp vaccine

1 dose of DT vaccine

Outcomes

Primary Outcome Measures

Incidence of adverse reactions 0-30 days after vaccination

Secondary Outcome Measures

Incidence of adverse reactions within 30 minutes of vaccination
Incidence of adverse reactions/adverse events 0-7 days after vaccination
Incidence of adverse events 0-30 days after vaccination
Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group
Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group
Hemoglobin content (HGB) on day 4 after vaccination
White blood cell count on day 4 after vaccination
Alanine aminotransferase (ALT) in blood on day 4 after vaccination
Aspartate aminotransferase (AST) in blood on day 4 after vaccination
Total bilirubin (TBIL) in blood on day 4 after vaccination
Protein in urine on day 4 after vaccination
Erythrocytes in urine on day 4 after vaccination
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
Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination

Full Information

First Posted
September 19, 2023
Last Updated
September 25, 2023
Sponsor
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06056050
Brief Title
A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The vaccines used in China's immunization program for the prevention of pertussis, tetanus and diphtheria include the adsorbed cell-free diphtheria-tetanus-acellular pertussis vaccine (DTaP) and the diphtheria-tetanus-acellular tetanus vaccine (DT) and tetanus vaccine. Among them, DTaP vaccination is for children from 3 months of age to 6 years of age, with one dose each at 3, 4, 5, and 18 months of age; DT vaccination is for children under 12 years of age, with one dose at 6 weeks of age after completing four doses of DTaP vaccination. However, infant and young child vaccination is no longer sufficient to prevent the threat of this disease, mainly due to the rapid decay of immune protection in adolescents and adults, and infections in this population, which are the main source of infection leading to infection in infants and young children, have been a number of new preventive strategies are being evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis
Keywords
Vaccine, Five Components, Immunogenicity, Safety, ≥6 years, Acellular

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental vaccine group 1A,≥18 years old
Arm Type
Experimental
Arm Description
1 dose of Tdcp vaccine
Arm Title
Control vaccine group 1B,≥18 years old
Arm Type
Active Comparator
Arm Description
1 dose of PPV23 vaccine
Arm Title
Experimental vaccine group 2A,12~17 years old
Arm Type
Experimental
Arm Description
1 dose of Tdcp vaccine
Arm Title
Control vaccine group 2B,12~17 years old
Arm Type
Active Comparator
Arm Description
1 dose of PPV23 vaccine
Arm Title
Experimental vaccine group 3A,6~11 years old
Arm Type
Experimental
Arm Description
1 dose of Tdcp vaccine
Arm Title
Control vaccine group 3B,6~11 years old
Arm Type
Active Comparator
Arm Description
1 dose of DT vaccine
Intervention Type
Biological
Intervention Name(s)
Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
Intervention Description
1 dose of Tdcp vaccine (0.5ml) on Day 0
Intervention Type
Biological
Intervention Name(s)
23-Valent Pneumococcal Polysaccharide Vaccine(PPV23)
Intervention Description
1 dose of PPV23 vaccine (0.5ml) on Day 0
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)
Intervention Description
1 dose of DT vaccine (0.5ml) on Day 0
Primary Outcome Measure Information:
Title
Incidence of adverse reactions 0-30 days after vaccination
Time Frame
0-30 days after vaccination
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions within 30 minutes of vaccination
Time Frame
Within 30 minutes of vaccination
Title
Incidence of adverse reactions/adverse events 0-7 days after vaccination
Time Frame
0-7 days after vaccination
Title
Incidence of adverse events 0-30 days after vaccination
Time Frame
0-30 days after vaccination
Title
Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group
Time Frame
360 days after vaccination
Title
Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group
Time Frame
180 days after vaccination
Title
Hemoglobin content (HGB) on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
White blood cell count on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
Alanine aminotransferase (ALT) in blood on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
Aspartate aminotransferase (AST) in blood on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
Total bilirubin (TBIL) in blood on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
Protein in urine on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
Erythrocytes in urine on day 4 after vaccination
Time Frame
Day 4 after vaccination
Title
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
Time Frame
30 days after vaccination
Title
Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Time Frame
30 days after vaccination
Title
Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Time Frame
30 days after vaccination
Title
Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination
Time Frame
30 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥ 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingxuan Wan
Phone
022-58213600-6051
Email
jingxuan.wan@cansinotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaobai Zhang
Phone
029-8221 9947
Email
maolyzhang@163.com
Facility Information:
Facility Name
Shaanxi Center for Disease Control and Prevention
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710054
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaobai Zhang
Phone
02982219947
Email
maolyzhang@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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