- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820883
A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
September 8, 2016 updated by: Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
A Single-center, Dose-escalation, Open-label Pilot Study to Evaluate the Safety and Tolerability of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
This is 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Taixing, Jiangsu, China, 225452
- Taixing county disease control and prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High dosage vaccine
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
|
two doses of 60µg/0.6ml
per dose
|
Experimental: Middle dosage vaccine
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
|
two doses of 30µg/0.6ml
per dose
|
Experimental: Low dosage vaccine
Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
|
two doses of 15µg/0.6ml
per dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of solicited adverse reactions after vaccination.
Time Frame: within 0-14 days after the vaccination
|
Occurrence of solicited site adverse reactions within 0-14 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
|
within 0-14 days after the vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of unsolicited adverse reactions after vaccination.
Time Frame: within 0-35 days after the vaccination
|
Occurrence of unsolicited adverse reactions within 0-35 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
|
within 0-35 days after the vaccination
|
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 (Escherichia coli).
|
within 6 months after the vaccination
|
Changes of the laboratory examinations after vaccination.
Time Frame: day 3 after the vaccination
|
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 3.
|
day 3 after the vaccination
|
Changes of the laboratory examinations after vaccination.
Time Frame: day 7 after the vaccination
|
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 7.
|
day 7 after the vaccination
|
Changes of the laboratory examinations after vaccination.
Time Frame: day 10 after the vaccination
|
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 10.
|
day 10 after the vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
June 30, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Estimate)
September 12, 2016
Last Update Submitted That Met QC Criteria
September 8, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSVCT027a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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