A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
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
1 other identifier
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2016
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
First Submitted
Initial submission to the registry
June 11, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedOctober 17, 2017
October 1, 2017
10 months
June 11, 2016
October 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Occurrence of injection site adverse reactions after vaccination
Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
within 21 days after the vaccination
Occurrence of systematic adverse reactions after vaccination
Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
within 21 days after the vaccination
Secondary Outcomes (7)
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.
day 0-17 after the vaccination
Changes of the blood biochemistry after vaccination.
day 0-17 after the vaccination
Geometric mean titre against specific antigens
within 6 months after the vaccination
- +2 more secondary outcomes
Other Outcomes (3)
Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination.
within 6 months after the vaccination
Specific functional antibody responses to the Staphylococcus aureus vaccine
within 6 months after the vaccination
Specific T cell immune responses to the Staphylococcus aureus vaccine.
within 6 months after the vaccination
Study Arms (7)
Four doses of low dose vaccine
EXPERIMENTALfour doses of 15µg/0.6ml per dose
Four doses of middle dose vaccine
EXPERIMENTALfour doses of 30µg/0.6ml per dose
Four doses of high dose vaccine
EXPERIMENTALfour doses of 60µg/0.6ml per dose
Three doses of low dose vaccine and one dose of placebo
EXPERIMENTALthree doses of 15µg/0.6ml per dose and one dose of placebo
Three doses of middle dose vaccine and one dose of placebo
EXPERIMENTALthree doses of 30µg/0.6ml per dose and one dose of placebo
Three doses of high dose vaccine and one dose of placebo
EXPERIMENTALthree doses of 60µg/0.6ml per dose and one dose of placebo
Four doses of placebo
PLACEBO COMPARATORfour doses of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiaokui Hu
Taishing, Jiangsu, 210009, China
Related Publications (1)
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: 35473663DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2016
First Posted
June 17, 2016
Study Start
September 1, 2016
Primary Completion
July 1, 2017
Study Completion
September 1, 2017
Last Updated
October 17, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share