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出境医 / 临床实验 / A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

Study Description
Brief Summary:
This is a single center, open-label phase1b clinical trial. The study will evaluate the safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day 0/0-3-7, day 0/0-7 and day 0/0-7-14.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Infection Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single-center, Open-label, Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) With Different Dose in Healthy Adults Aged 18-70 Years in China
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : May 16, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Immunization schedule of day 0-3-7
Three doses of schedule given at day 0, 3 and 7.
 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
Experimental: Immunization schedule of day 0/0-3-7
Four doses of schedule given at day 0/0, 3 and 7.
 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
Experimental: Immunization schedule of day 0/0-7
Three doses of schedule given at day 0/0 and 7.
 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
Experimental: Immunization schedule of day 0/0-7-14
Four doses of schedule given at day 0/0, 7 and 14.
 Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Outcome Measures
Primary Outcome Measures :
  1. Occurrence of solicited adverse reactions after vaccination [ Time Frame: within 21 days after vaccination ]
    Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant


Secondary Outcome Measures :
  1. Occurrence of unsolicited adverse reactions after vaccination [ Time Frame: within 42 days after the vaccination ]
    Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine

  2. Occurrence of serious adverse events after the vaccination. [ Time Frame: within 6 months after the vaccination ]
    Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine

  3. Changes of the blood routine after vaccination. [ Time Frame: within 17 days after the vaccination ]
    Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.

  4. Changes of the blood biochemistry after vaccination. [ Time Frame: within 17 days after the vaccination ]
    Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.

  5. Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine [ Time Frame: within 42 days after vaccianation ]
    Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine at day 7, 14, 21 and 42, respectively.

  6. Specific functional antibody responses to the Staphylococcus aureus vaccine [ Time Frame: within 42 days after vaccianation ]
    Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21 and 42


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers aged 18 to 70 years (aged over 18 and under 71 years)

    • Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
    • Able to understand the content of informed consent and willing to sign the informed consent.
    • Able to complete the diary card independently.
    • For females only (18-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
    • Axillary temperature ≤37.0°C.

Exclusion Criteria:

  • • Prior receipt of Staphylococcus aureus vaccine

    • Any confirmed Staphylococcus aureus infection disease in the past 12 month.
    • History of asthma, hereditary angioneurotic edema, diabetes, malignancy or other serious disease. Participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
    • Prior blood donation or Blood loss over 400ml in the last 3 months;
    • Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
    • History of allergic disease likely to be exacerbated by any component of the vaccine, including allergy, urticaria, respiratory difficulty, angioneurotic edema or abdominal pain. Any autoimmune disease or immunodeficient state, parents, brother and sister with autoimmune disease or immunodeficient disease.
    • Taking immunoglobulins and/or any blood products within the last 12 months.
    • Asplenia, functional asplenia or asplenia caused by any situation or splenectomy.
    • Any acute disease or acute attack of chronic disease in last 7 days.
    • History of thyroidectomy or thyroid disease requiring treatment in the last 12 months.
    • Immunosuppressor, cytotoxic therapy, inhaled corticosteroid (excluding corticosteroids spray treatment of allergic rhinitis, acute and nonconcurrent corticosteroids treatment)
    • Participation in another research study involving receipt of an investigational product in the last 30 days.
    • Woman who is breast-feeding.
    • Prior administration of attenuated vaccine in last 28 days.
    • Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
    • Current anti-tuberculosis therapy or HIV infected individuals
    • Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.

Following Immunization exclusion standard:

  • Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
  • Any grade 3 or more serious adverse reaction associated with vaccination since the last vaccination.
  • According to the investigator, the participant should not continue participating in the study.
Contacts and Locations

Locations
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China, Jiangsu
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China, 221000
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Chengdu Olymvax Biopharmaceuticals Inc.
PLA Army Medical University
Investigators
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Study Director: Fangyue Meng, Master Jiangsu, China
Tracking Information
First Submitted Date  ICMJE May 25, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE May 16, 2019
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2019) 		Occurrence of solicited adverse reactions after vaccination [ Time Frame: within 21 days after vaccination ]
Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2019)
  • Occurrence of unsolicited adverse reactions after vaccination [ Time Frame: within 42 days after the vaccination ]
    Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
  • Occurrence of serious adverse events after the vaccination. [ Time Frame: within 6 months after the vaccination ]
    Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine
  • Changes of the blood routine after vaccination. [ Time Frame: within 17 days after the vaccination ]
    Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
  • Changes of the blood biochemistry after vaccination. [ Time Frame: within 17 days after the vaccination ]
    Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
  • Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine [ Time Frame: within 42 days after vaccianation ]
    Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine at day 7, 14, 21 and 42, respectively.
  • Specific functional antibody responses to the Staphylococcus aureus vaccine [ Time Frame: within 42 days after vaccianation ]
    Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21 and 42
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
Official Title  ICMJE A Single-center, Open-label, Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) With Different Dose in Healthy Adults Aged 18-70 Years in China
Brief Summary This is a single center, open-label phase1b clinical trial. The study will evaluate the safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day 0/0-3-7, day 0/0-7 and day 0/0-7-14.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcus Aureus Infection
Intervention  ICMJE
  • Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
    36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
  • Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
    36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
  • Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
    36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
  • Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
    36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Study Arms  ICMJE
  • Experimental: Immunization schedule of day 0-3-7
    Three doses of schedule given at day 0, 3 and 7.
    Intervention: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
  • Experimental: Immunization schedule of day 0/0-3-7
    Four doses of schedule given at day 0/0, 3 and 7.
    Intervention: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
  • Experimental: Immunization schedule of day 0/0-7
    Three doses of schedule given at day 0/0 and 7.
    Intervention: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
  • Experimental: Immunization schedule of day 0/0-7-14
    Four doses of schedule given at day 0/0, 7 and 14.
    Intervention: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2019) 		144
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 16, 2020
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers aged 18 to 70 years (aged over 18 and under 71 years)

    • Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
    • Able to understand the content of informed consent and willing to sign the informed consent.
    • Able to complete the diary card independently.
    • For females only (18-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
    • Axillary temperature ≤37.0°C.

Exclusion Criteria:

  • • Prior receipt of Staphylococcus aureus vaccine

    • Any confirmed Staphylococcus aureus infection disease in the past 12 month.
    • History of asthma, hereditary angioneurotic edema, diabetes, malignancy or other serious disease. Participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
    • Prior blood donation or Blood loss over 400ml in the last 3 months;
    • Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
    • History of allergic disease likely to be exacerbated by any component of the vaccine, including allergy, urticaria, respiratory difficulty, angioneurotic edema or abdominal pain. Any autoimmune disease or immunodeficient state, parents, brother and sister with autoimmune disease or immunodeficient disease.
    • Taking immunoglobulins and/or any blood products within the last 12 months.
    • Asplenia, functional asplenia or asplenia caused by any situation or splenectomy.
    • Any acute disease or acute attack of chronic disease in last 7 days.
    • History of thyroidectomy or thyroid disease requiring treatment in the last 12 months.
    • Immunosuppressor, cytotoxic therapy, inhaled corticosteroid (excluding corticosteroids spray treatment of allergic rhinitis, acute and nonconcurrent corticosteroids treatment)
    • Participation in another research study involving receipt of an investigational product in the last 30 days.
    • Woman who is breast-feeding.
    • Prior administration of attenuated vaccine in last 28 days.
    • Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
    • Current anti-tuberculosis therapy or HIV infected individuals
    • Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.

Following Immunization exclusion standard:

  • Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
  • Any grade 3 or more serious adverse reaction associated with vaccination since the last vaccination.
  • According to the investigator, the participant should not continue participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966040
Other Study ID Numbers  ICMJE JSVCT049
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: within 6 months of study completion
Access Criteria: Data access requests will be reviewed by the sponsor and requestors will be required to sign a Date Access Agreement.
Responsible Party Jiangsu Province Centers for Disease Control and Prevention
Study Sponsor  ICMJE Jiangsu Province Centers for Disease Control and Prevention
Collaborators  ICMJE
  • Chengdu Olymvax Biopharmaceuticals Inc.
  • PLA Army Medical University
Investigators  ICMJE
Study Director: Fangyue Meng, Master Jiangsu, China
PRS Account Jiangsu Province Centers for Disease Control and Prevention
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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