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

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 1

Conditions: Staphylococcus Aureus Infection

Treatments: Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7; Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14; Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7; Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT03966040

JSVCT049

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 4 patient groups

Immunization schedule of day 0-3-7

Experimental group

Description:

Three doses of schedule given at day 0, 3 and 7.

Treatment:

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

Immunization schedule of day 0/0-3-7

Experimental group

Description:

Four doses of schedule given at day 0/0, 3 and 7.

Treatment:

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

Immunization schedule of day 0/0-7

Experimental group

Description:

Three doses of schedule given at day 0/0 and 7.

Treatment:

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

Immunization schedule of day 0/0-7-14

Experimental group

Description:

Four doses of schedule given at day 0/0, 7 and 14.

Treatment:

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