Staphylococcus Aureus InfectionPhase 1NCT02804711
A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
A Phase 1 study testing Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml), Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) and High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) in people with Staphylococcus Aureus Infection, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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. 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?
- Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml), Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) and High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Sep 2017
- Phase
- 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.
Show all 24Show fewer
- 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.
About this study
Official title: 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
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.
- Conditions
- Staphylococcus Aureus Infection
- Being tested
- Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml), Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml), High dosage of Staphylococcus aureus vaccine (60µg/0.6ml), Placebo
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)Biological
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)Biological
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Four doses of low dose vaccine | Experimental | four doses of 15µg/0.6ml per dose Receives: Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml) |
| Four doses of middle dose vaccine | Experimental | four doses of 30µg/0.6ml per dose Receives: Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) |
| Four doses of high dose vaccine | Experimental | four doses of 60µg/0.6ml per dose Receives: Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) |
| Three doses of low dose vaccine and one dose of placebo | Experimental | three doses of 15µg/0.6ml per dose and one dose of placebo Receives: Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml); Biological: Placebo |
| Three doses of middle dose vaccine and one dose of placebo | Experimental | three doses of 30µg/0.6ml per dose and one dose of placebo Receives: Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml); Biological: Placebo |
| Three doses of high dose vaccine and one dose of placebo | Experimental | three doses of 60µg/0.6ml per dose and one dose of placebo Receives: Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml); Biological: Placebo |
| Four doses of placebo | Placebo comparator | four doses of placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 21 days after the vaccination
Secondary outcomes (7)
Occurrence of unsolicited adverse reactions after vaccination.
Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Measured: within 42 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
Measured: within 6 months after the vaccination
Changes of the blood routine after vaccination.
Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
Measured: day 0-17 after the vaccination
Changes of the blood biochemistry after vaccination.
Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
Measured: day 0-17 after the vaccination
Geometric mean titre against specific antigens
Geometric mean titre measured at day 0, 7, 14, 21, 42 and month 3, 6.
Measured: within 6 months after the vaccination
Geometric mean fold increase against specific antigens
Geometric mean fold increase measured at day 7, 14, 21, 42 and month 3, 6.
Measured: within 6 months after the vaccination
Positive conversion rate of serum against specific antigens
Positive conversion rate of serum measured at day 7, 14, 21, 42 and month 3, 6.
Measured: within 6 months 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 posted17 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804711
- Sponsor's protocol ID
- JSVCT027
- Status last verified
- Oct 2017
- First submitted
- 11 Jun 2016
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35473663
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02804711
- Acronym / sponsor ID
- JSVCT027
- Conditions
- Staphylococcus Aureus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Chengdu Olymvax Biopharmaceuticals Inc., Third Military Medical University
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Jun 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Four doses of low dose vaccine | Experimental | Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)four doses of 15µg/0.6ml per dose |
| Four doses of middle dose vaccine | Experimental | Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)four doses of 30µg/0.6ml per dose |
| Four doses of high dose vaccine | Experimental | Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)four doses of 60µg/0.6ml per dose |
| Three doses of low dose vaccine and one dose of placebo | Experimental | Biological: Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml), Biological: Placebothree doses of 15µg/0.6ml per dose and one dose of placebo |
| Three doses of middle dose vaccine and one dose of placebo | Experimental | Biological: Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml), Biological: Placebothree doses of 30µg/0.6ml per dose and one dose of placebo |
| Three doses of high dose vaccine and one dose of placebo | Experimental | Biological: High dosage of Staphylococcus aureus vaccine (60µg/0.6ml), Biological: Placebothree doses of 60µg/0.6ml per dose and one dose of placebo |
| Four doses of placebo | Placebo comparator | Biological: Placebofour doses of placebo |
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 |
|---|---|---|
| Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml) | Biological | Four doses of low dose vaccine, Three doses of low dose vaccine and one dose of placebo |
| Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) | Biological | Four doses of middle dose vaccine, Three doses of middle dose vaccine and one dose of placebo |
| High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) | Biological | Four doses of high dose vaccine, Three doses of high dose vaccine and one dose of placebo |
| Placebo | Biological | Four doses of placebo, Three doses of high dose vaccine and one dose of placebo, Three doses of low dose vaccine and one dose of placebo, Three doses of middle dose vaccine and one dose of placebo |
Primary outcome
Occurrence of injection site adverse reactions after vaccination
Time frame: within 21 days after the vaccination
Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Occurrence of systematic adverse reactions after vaccination
Time frame: within 21 days after the vaccination
Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
7 secondary outcomes
Occurrence of unsolicited adverse reactions after vaccination.
Time frame: within 42 days after the vaccination
Occurrence of serious adverse events after the vaccination.
Time frame: within 6 months after the vaccination
Changes of the blood routine after vaccination.
Time frame: day 0-17 after the vaccination
Changes of the blood biochemistry after vaccination.
Time frame: day 0-17 after the vaccination
Geometric mean titre against specific antigens
Time frame: within 6 months after the vaccination
Geometric mean fold increase against specific antigens
Time frame: within 6 months after the vaccination
Positive conversion rate of serum against specific antigens
Time frame: within 6 months 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 17 Oct 2017.
- Derived from this study: PubMed 35473663Zhu 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.
- Individual participant dataSharing planned: No
Related trials for Staphylococcus Aureus Infection
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
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 Phase 1 study testing Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml), Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) and High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) 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 17 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 injection site adverse reactions after vaccination (time frame: within 21 days after the vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804711, which also lists 1 linked publication.
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 17 Oct 2017.