A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

NCT02820883 | Completed Early Phase 1 DMC

• 1 other identifier: JSVCT027a
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (1)

• Occurrence of solicited adverse reactions after vaccination.

  Occurrence of solicited site adverse reactions within 0-14 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).

  within 0-14 days after the vaccination

Secondary Outcomes (5)

• 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 3 after the vaccination

• Changes of the laboratory examinations after vaccination.

  day 7 after the vaccination

• Changes of the laboratory examinations after vaccination.

  day 10 after the vaccination

Study Arms (3)

High dosage vaccine

EXPERIMENTAL

High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)

Biological: Staphylococcus aureus vaccine (60µg/per protein)

Middle dosage vaccine

EXPERIMENTAL

Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)

Biological: Staphylococcus aureus vaccine (30µg/per protein)

Low dosage vaccine

EXPERIMENTAL

Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)

Biological: Staphylococcus aureus vaccine (15µg/per protein)

Interventions

Staphylococcus aureus vaccine (60µg/per protein) BIOLOGICAL

two doses of 60µg/0.6ml per dose

High dosage vaccine

Staphylococcus aureus vaccine (30µg/per protein) BIOLOGICAL

two doses of 30µg/0.6ml per dose

Middle dosage vaccine

Staphylococcus aureus vaccine (15µg/per protein) BIOLOGICAL

two doses of 15µg/0.6ml per dose

Low dosage vaccine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 non-concurrent 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Chengdu Olymvax Biopharmaceuticals Inc.: collaborator
• Third Military Medical University: collaborator

Study Sites (1)

Taixing county disease control and prevention

Taishing, Jiangsu, 225452, China

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)