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

Staphylococcus Aureus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966040
• Other study ID #: JSVCT049
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2019
• Est. completion date: May 16, 2020

Study information

• Verified date: May 2019
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 16, 2020
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Staphylococcal Infections
• Staphylococcus Aureus Infection

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
China	Suining County Center for Disease Control and Prevention	Xuzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Chengdu Olymvax Biopharmaceuticals Inc., PLA Army Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited adverse reactions after vaccination	Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant	within 21 days after vaccination
Secondary	Occurrence of unsolicited adverse reactions after vaccination	Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine	within 42 days after the vaccination
Secondary	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	within 6 months after the vaccination
Secondary	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.	within 17 days after the vaccination
Secondary	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.	within 17 days after the vaccination
Secondary	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.	within 42 days after vaccianation
Secondary	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	within 42 days after vaccianation