A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
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
1 other identifier
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2019
CompletedFirst Submitted
Initial submission to the registry
May 25, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2020
CompletedMarch 30, 2021
May 1, 2019
7 months
May 25, 2019
March 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of solicited adverse reactions after vaccination
Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant
within 21 days after vaccination
Secondary Outcomes (6)
Occurrence of unsolicited adverse reactions after vaccination
within 42 days after the vaccination
Occurrence of serious adverse events after the vaccination.
within 6 months after the vaccination
Changes of the blood routine after vaccination.
within 17 days after the vaccination
Changes of the blood biochemistry after vaccination.
within 17 days after the vaccination
Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine
within 42 days after vaccianation
- +1 more secondary outcomes
Study Arms (4)
Immunization schedule of day 0-3-7
EXPERIMENTALThree doses of schedule given at day 0, 3 and 7.
Immunization schedule of day 0/0-3-7
EXPERIMENTALFour doses of schedule given at day 0/0, 3 and 7.
Immunization schedule of day 0/0-7
EXPERIMENTALThree doses of schedule given at day 0/0 and 7.
Immunization schedule of day 0/0-7-14
EXPERIMENTALFour doses of schedule given at day 0/0, 7 and 14.
Interventions
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221000, China
Related Publications (2)
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.
PMID: 35473663DERIVEDWei 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.
PMID: 33873093DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fangyue Meng, Master
Jiangsu, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2019
First Posted
May 29, 2019
Study Start
May 16, 2019
Primary Completion
December 16, 2019
Study Completion
May 16, 2020
Last Updated
March 30, 2021
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
Deidentified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.