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

Jiangsu Province Centers for Disease Control and Prevention1 site in 1 country144 target enrollmentMay 16, 2019

ConditionsStaphylococcus Aureus Infection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Staphylococcus Aureus Infection
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Enrollment: 144
Locations: 1
Primary Endpoint: Occurrence of solicited adverse reactions after vaccination
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 16, 2019

End Date

May 16, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Specific functional antibody responses to the Staphylococcus aureus vaccine(within 42 days after vaccianation)
Occurrence of unsolicited adverse reactions after vaccination(within 42 days after the vaccination)
Occurrence of serious adverse events after the vaccination.(within 6 months after the vaccination)
Changes of the blood biochemistry after vaccination.(within 17 days after the vaccination)
Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine(within 42 days after vaccianation)
Changes of the blood routine after vaccination.(within 17 days after the vaccination)