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

March 28, 2021 updated by: Jiangsu Province Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • 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

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Suining County Center for 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunization schedule of day 0-3-7
Three doses of schedule given at day 0, 3 and 7.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
Experimental: Immunization schedule of day 0/0-3-7
Four doses of schedule given at day 0/0, 3 and 7.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
Experimental: Immunization schedule of day 0/0-7
Three doses of schedule given at day 0/0 and 7.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
Experimental: Immunization schedule of day 0/0-7-14
Four doses of schedule given at day 0/0, 7 and 14.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of solicited adverse reactions after vaccination
Time Frame: within 21 days after vaccination
Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant
within 21 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of unsolicited adverse reactions after vaccination
Time Frame: within 42 days after the vaccination
Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
within 42 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
within 6 months after the vaccination
Changes of the blood routine after vaccination.
Time Frame: within 17 days after the vaccination
Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
within 17 days after the vaccination
Changes of the blood biochemistry after vaccination.
Time Frame: within 17 days after the vaccination
Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
within 17 days after the vaccination
Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine
Time Frame: within 42 days after vaccianation
Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine at day 7, 14, 21 and 42, respectively.
within 42 days after vaccianation
Specific functional antibody responses to the Staphylococcus aureus vaccine
Time Frame: within 42 days after vaccianation
Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21 and 42
within 42 days after vaccianation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Chengdu Olymvax Biopharmaceuticals Inc.
PLA Army Medical University

Investigators

  • Study Director: Fangyue Meng, Master, Jiangsu, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 16, 2019

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

May 16, 2020

Study Registration Dates

First Submitted

May 25, 2019

First Submitted That Met QC Criteria

May 25, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 28, 2021

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSVCT049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.

IPD Sharing Time Frame

within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the sponsor and requestors will be required to sign a Date Access Agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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