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Staphylococcus Aureus InfectionPhase 1NCT03966040

A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

A Phase 1 study testing Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7, Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 and Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7 in people with Staphylococcus Aureus Infection, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Staphylococcus Aureus Infection
What is being tested?
Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7, Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 and Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteChina
Study dates
16 May 2019to 16 May 2020
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • • 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.
Show all 21Show fewer
  • 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.
  • Current anti-tuberculosis therapy or HIV infected individuals
  • Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
  • Following Immunization exclusion standard:
  • Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
  • Any grade 3 or more serious adverse reaction associated with vaccination since the last vaccination.
  • According to the investigator, the participant should not continue participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Suining County Center for Disease Control and Prevention

    Xuzhou, Jiangsu, 221000

Other trials in China

About this study

Official title: 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

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.

Being tested
Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7, Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7, Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7, Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Medical subject headings
Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7Biological

    36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7

  • Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7Biological

    36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7

  • Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7Biological

    36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7

  • Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14Biological

    36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14

Study groups in NCT03966040
Study groupRoleWhat they receive
Immunization schedule of day 0-3-7ExperimentalThree doses of schedule given at day 0, 3 and 7.
Receives: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
Immunization schedule of day 0/0-3-7ExperimentalFour doses of schedule given at day 0/0, 3 and 7.
Receives: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
Immunization schedule of day 0/0-7ExperimentalThree doses of schedule given at day 0/0 and 7.
Receives: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
Immunization schedule of day 0/0-7-14ExperimentalFour doses of schedule given at day 0/0, 7 and 14.
Receives: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of solicited adverse reactions after vaccination

    Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant

    Measured: within 21 days after vaccination

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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: within 17 days after the vaccination

  4. 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: within 17 days after the vaccination

  5. Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine

    Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine at day 7, 14, 21 and 42, respectively.

    Measured: within 42 days after vaccianation

  6. Specific functional antibody responses to the Staphylococcus aureus vaccine

    Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21 and 42

    Measured: within 42 days after vaccianation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start16 May 2019
  3. Primary completion16 Dec 2019
  4. Study completion16 May 2020

Resources

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
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03966040
Sponsor's protocol ID
JSVCT049
Status last verified
May 2019
First submitted
25 May 2019
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.

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

  • Wei 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.

    PubMed 33873093

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7, Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 and Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7 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 21 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 30 Mar 2021. 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?

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 solicited adverse reactions after vaccination (time frame: within 21 days after vaccination). 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 NCT03966040, which also lists 2 linked publications.

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 30 Mar 2021.

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