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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804711
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : October 17, 2017
Sponsor:
Collaborators:
Chengdu Olymvax Biopharmaceuticals Inc.
Third Military Medical University
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Brief Summary:

Before this study, there will be an open-label, dose-escalation pilot study with a total of 30 participants with 10 per dosage group. The aim of the pilot study is to explore the preliminary safety of an experimental recombinant staphylococcus aureus vaccine.

This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an experimental recombinant staphylococcus aureus vaccine. The study will be carried out following a dose-escalation method from the low dosage to the high dosage, i.e. the higher dosage vaccine could only be administrated after the first seven-day safety of the lower dosage vaccine is confirmed after safety observation.


Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Infection Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml) Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase Ia Single-center, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
Actual Study Start Date : September 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Four doses of low dose vaccine
four doses of 15µg/0.6ml per dose
Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Experimental: Four doses of middle dose vaccine
four doses of 30µg/0.6ml per dose
Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
Experimental: Four doses of high dose vaccine
four doses of 60µg/0.6ml per dose
Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Experimental: Three doses of low dose vaccine and one dose of placebo
three doses of 15µg/0.6ml per dose and one dose of placebo
Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Biological: Placebo
Experimental: Three doses of middle dose vaccine and one dose of placebo
three doses of 30µg/0.6ml per dose and one dose of placebo
Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
Biological: Placebo
Experimental: Three doses of high dose vaccine and one dose of placebo
three doses of 60µg/0.6ml per dose and one dose of placebo
Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Biological: Placebo
Placebo Comparator: Four doses of placebo
four doses of placebo
Biological: Placebo



Primary Outcome Measures :
  1. Occurrence of injection site adverse reactions after vaccination [ Time Frame: within 21 days after the vaccination ]
    Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine

  2. Occurrence of systematic adverse reactions after vaccination [ Time Frame: within 21 days after the vaccination ]
    Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine


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: day 0-17 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: day 0-17 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. Geometric mean titre against specific antigens [ Time Frame: within 6 months after the vaccination ]
    Geometric mean titre measured at day 0, 7, 14, 21, 42 and month 3, 6.

  6. Geometric mean fold increase against specific antigens [ Time Frame: within 6 months after the vaccination ]
    Geometric mean fold increase measured at day 7, 14, 21, 42 and month 3, 6.

  7. Positive conversion rate of serum against specific antigens [ Time Frame: within 6 months after the vaccination ]
    Positive conversion rate of serum measured at day 7, 14, 21, 42 and month 3, 6.


Other Outcome Measures:
  1. Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination. [ Time Frame: within 6 months after the vaccination ]
    Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination with the Staphylococcus aureus vaccine at day at day 3, 7, 10, 14, 17, 21, 42 and month 3, 6.

  2. Specific functional antibody responses to the Staphylococcus aureus vaccine [ Time Frame: within 6 months after the vaccination ]
    Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21, 42 and month 3, 6.

  3. Specific T cell immune responses to the Staphylococcus aureus vaccine. [ Time Frame: within 6 months after the vaccination ]
    Specific T cell immune responses to the Staphylococcus aureus vaccine at day at day7, 14, 21, 42 and month 3, 6 measured by ELISpot.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy volunteers aged 18 to 65 years (aged over 18 and under 66 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:

First Immunization exclusion standard:

  • 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 non-concurrent 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 prophylaxis or therapy
  • Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.

Following Immunization exclusion standard:

  • Any grade 3 or more serious adverse reaction happen since the last vaccination.
  • Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
  • Acute or chronic infections at the vaccination day (axillary temperature>37.0°C).
  • According to the investigator, the participant should not continue participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804711


Locations
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China, Jiangsu
Xiaokui Hu
Taixing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Chengdu Olymvax Biopharmaceuticals Inc.
Third Military Medical University
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02804711    
Other Study ID Numbers: JSVCT027
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs