A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
NCT ID: NCT03966040
Last Updated: 2021-03-30
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
2019-05-16
2020-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Immunization schedule of day 0-3-7
Three doses of schedule given at day 0, 3 and 7.
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
Immunization schedule of day 0/0-3-7
Four doses of schedule given at day 0/0, 3 and 7.
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
Immunization schedule of day 0/0-7
Three doses of schedule given at day 0/0 and 7.
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
Immunization schedule of day 0/0-7-14
Four doses of schedule given at day 0/0, 7 and 14.
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
Interventions
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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
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
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
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
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.
* 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.
Exclusion Criteria
* 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:
18 Years
70 Years
ALL
Yes
Sponsors
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Chengdu Olymvax Biopharmaceuticals Inc.
INDUSTRY
PLA Army Medical University
UNKNOWN
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Principal Investigators
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Fangyue Meng, Master
Role: STUDY_DIRECTOR
Jiangsu, China
Locations
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Suining County Center for Disease Control and Prevention
Xuzhou, 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.
Wei J, Cheng X, Zhang Y, Gao C, Wang Y, Peng Q, Luo P, Yang L, Zou Q, Zeng H, Gu J. Identification and application of a neutralizing epitope within alpha-hemolysin using human serum antibodies elicited by vaccination. Mol Immunol. 2021 Jul;135:45-52. doi: 10.1016/j.molimm.2021.03.028. Epub 2021 Apr 16.
Other Identifiers
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JSVCT049
Identifier Type: -
Identifier Source: org_study_id
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