Staphylococcus Aureus InfectionEarly Phase 1NCT02820883
A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
A Early Phase 1 study testing Staphylococcus aureus vaccine (60µg/per protein), Staphylococcus aureus vaccine (30µg/per protein) and Staphylococcus aureus vaccine (15µg/per protein) in people with Staphylococcus Aureus Infection, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Staphylococcus Aureus Infection
- What is being tested?
- Staphylococcus aureus vaccine (60µg/per protein), Staphylococcus aureus vaccine (30µg/per protein) and Staphylococcus aureus vaccine (15µg/per protein)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Aug 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Taixing county disease control and prevention
Taishing, Jiangsu, 225452
About this study
Official title: 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.
- Conditions
- Staphylococcus Aureus Infection
- Being tested
- Staphylococcus aureus vaccine (60µg/per protein), Staphylococcus aureus vaccine (30µg/per protein), Staphylococcus aureus vaccine (15µg/per protein)
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphylococcus aureus vaccine (60µg/per protein)Biological
two doses of 60µg/0.6ml per dose
Staphylococcus aureus vaccine (30µg/per protein)Biological
two doses of 30µg/0.6ml per dose
Staphylococcus aureus vaccine (15µg/per protein)Biological
two doses of 15µg/0.6ml per dose
| Study group | Role | What they receive |
|---|---|---|
| High dosage vaccine | Experimental | High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) Receives: Biological: Staphylococcus aureus vaccine (60µg/per protein) |
| Middle dosage vaccine | Experimental | Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) Receives: Biological: Staphylococcus aureus vaccine (30µg/per protein) |
| Low dosage vaccine | Experimental | Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml) Receives: Biological: Staphylococcus aureus vaccine (15µg/per protein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse reactions after vaccination.
Occurrence of solicited site adverse reactions within 0-14 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
Measured: within 0-14 days after the vaccination
Secondary outcomes (5)
Occurrence of unsolicited adverse reactions after vaccination.
Occurrence of unsolicited adverse reactions within 0-35 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
Measured: within 0-35 days after the vaccination
Occurrence of serious adverse events after the vaccination.
Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
Measured: within 6 months after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 3.
Measured: day 3 after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 7.
Measured: day 7 after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 10.
Measured: day 10 after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Chengdu Olymvax Biopharmaceuticals Inc., Third Military Medical University
- Responsible party
- Principal investigator, Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820883
- Sponsor's protocol ID
- JSVCT027a
- Status last verified
- Sep 2016
- First submitted
- 29 Jun 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02820883
- Acronym / sponsor ID
- JSVCT027a
- Conditions
- Staphylococcus Aureus Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Chengdu Olymvax Biopharmaceuticals Inc., Third Military Medical University
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dosage vaccine | Experimental | Biological: Staphylococcus aureus vaccine (60µg/per protein)High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) |
| Middle dosage vaccine | Experimental | Biological: Staphylococcus aureus vaccine (30µg/per protein)Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) |
| Low dosage vaccine | Experimental | Biological: Staphylococcus aureus vaccine (15µg/per protein)Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staphylococcus aureus vaccine (60µg/per protein)two doses of 60µg/0.6ml per dose | Biological | High dosage vaccine |
| Staphylococcus aureus vaccine (30µg/per protein)two doses of 30µg/0.6ml per dose | Biological | Middle dosage vaccine |
| Staphylococcus aureus vaccine (15µg/per protein)two doses of 15µg/0.6ml per dose | Biological | Low dosage vaccine |
Primary outcome
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).
5 secondary outcomes
Occurrence of unsolicited adverse reactions after vaccination.
Time frame: within 0-35 days after the vaccination
Occurrence of serious adverse events after the vaccination.
Time frame: 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.
Time frame: day 7 after the vaccination
Changes of the laboratory examinations after vaccination.
Time frame: day 10 after the vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Staphylococcus aureus vaccine (60µg/per protein), Staphylococcus aureus vaccine (30µg/per protein) and Staphylococcus aureus vaccine (15µg/per protein) in people with Staphylococcus Aureus Infection, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited adverse reactions after vaccination. (time frame: within 0-14 days after the vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.