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

Jiangsu Province Centers for Disease Control and Prevention1 site in 1 country30 target enrollmentJune 2016

ConditionsStaphylococcus Aureus Infection

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Staphylococcus Aureus Infection
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Enrollment: 30
Locations: 1
Primary Endpoint: Occurrence of solicited adverse reactions after vaccination.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

August 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Responsible Party

Principal Investigator

Fengcai Zhu

Professor

Jiangsu Province Centers for Disease Control and Prevention

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Occurrence of unsolicited adverse reactions after vaccination.(within 0-35 days after the vaccination)
Occurrence of serious adverse events after the vaccination.(within 6 months after the vaccination)
Changes of the laboratory examinations after vaccination.(day 10 after the vaccination)