A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
NCT ID: NCT02804711
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
144 participants
INTERVENTIONAL
2016-09-30
2017-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Four doses of low dose vaccine
four doses of 15µg/0.6ml per dose
Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Four doses of middle dose vaccine
four doses of 30µg/0.6ml per dose
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
Four doses of high dose vaccine
four doses of 60µg/0.6ml per dose
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Three doses of low dose vaccine and one dose of placebo
three doses of 15µg/0.6ml per dose and one dose of placebo
Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Placebo
Three doses of middle dose vaccine and one dose of placebo
three doses of 30µg/0.6ml per dose and one dose of placebo
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
Placebo
Three doses of high dose vaccine and one dose of placebo
three doses of 60µg/0.6ml per dose and one dose of placebo
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Placebo
Four doses of placebo
four doses of placebo
Placebo
Interventions
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Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
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 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.
18 Years
65 Years
ALL
No
Sponsors
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Chengdu Olymvax Biopharmaceuticals Inc.
INDUSTRY
Third Military Medical University
OTHER
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Locations
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Xiaokui Hu
Taishing, Jiangsu, China
Countries
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References
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Zhu FC, Zeng H, Li JX, Wang B, Meng FY, Yang F, Gu J, Liang HY, Hu YM, Liu P, Peng LS, Hu XK, Zhuang Y, Fan M, Li HB, Tan ZM, Luo P, Zhang P, Chu K, Zhang JY, Zeng M, Zou QM. Evaluation of a recombinant five-antigen Staphylococcus aureus vaccine: The randomized, single-centre phase 1a/1b clinical trials. Vaccine. 2022 May 20;40(23):3216-3227. doi: 10.1016/j.vaccine.2022.04.034. Epub 2022 Apr 23.
Other Identifiers
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JSVCT027
Identifier Type: -
Identifier Source: org_study_id