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

Primary Purpose

Staphylococcus Aureus Infection

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Placebo
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • 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.
  • Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
  • Current anti-tuberculosis prophylaxis or therapy
  • Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.

Following Immunization exclusion standard:

  • Any grade 3 or more serious adverse reaction happen since the last vaccination.
  • Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
  • Acute or chronic infections at the vaccination day (axillary temperature>37.0°C).
  • According to the investigator, the participant should not continue participating in the study.

Sites / Locations

  • Xiaokui Hu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Four doses of low dose vaccine

Four doses of middle dose vaccine

Four doses of high dose vaccine

Three doses of low dose vaccine and one dose of placebo

Three doses of middle dose vaccine and one dose of placebo

Three doses of high dose vaccine and one dose of placebo

Four doses of placebo

Arm Description

four doses of 15µg/0.6ml per dose

four doses of 30µg/0.6ml per dose

four doses of 60µg/0.6ml per dose

three doses of 15µg/0.6ml per dose and one dose of placebo

three doses of 30µg/0.6ml per dose and one dose of placebo

three doses of 60µg/0.6ml per dose and one dose of placebo

four doses of placebo

Outcomes

Primary Outcome Measures

Occurrence of injection site adverse reactions after vaccination
Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Occurrence of systematic adverse reactions after vaccination
Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine

Secondary Outcome Measures

Occurrence of unsolicited adverse reactions after vaccination.
Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
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
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.
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.
Geometric mean titre against specific antigens
Geometric mean titre measured at day 0, 7, 14, 21, 42 and month 3, 6.
Geometric mean fold increase against specific antigens
Geometric mean fold increase measured at day 7, 14, 21, 42 and month 3, 6.
Positive conversion rate of serum against specific antigens
Positive conversion rate of serum measured at day 7, 14, 21, 42 and month 3, 6.

Full Information

First Posted
June 11, 2016
Last Updated
October 14, 2017
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Chengdu Olymvax Biopharmaceuticals Inc., Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02804711
Brief Title
A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
Official Title
A Phase Ia Single-center, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Chengdu Olymvax Biopharmaceuticals Inc., Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Before this study, there will be 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. This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an experimental recombinant staphylococcus aureus vaccine. The study will be carried out following a dose-escalation method from the low dosage to the high dosage, i.e. the higher dosage vaccine could only be administrated after the first seven-day safety of the lower dosage vaccine is confirmed after safety observation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Four doses of low dose vaccine
Arm Type
Experimental
Arm Description
four doses of 15µg/0.6ml per dose
Arm Title
Four doses of middle dose vaccine
Arm Type
Experimental
Arm Description
four doses of 30µg/0.6ml per dose
Arm Title
Four doses of high dose vaccine
Arm Type
Experimental
Arm Description
four doses of 60µg/0.6ml per dose
Arm Title
Three doses of low dose vaccine and one dose of placebo
Arm Type
Experimental
Arm Description
three doses of 15µg/0.6ml per dose and one dose of placebo
Arm Title
Three doses of middle dose vaccine and one dose of placebo
Arm Type
Experimental
Arm Description
three doses of 30µg/0.6ml per dose and one dose of placebo
Arm Title
Three doses of high dose vaccine and one dose of placebo
Arm Type
Experimental
Arm Description
three doses of 60µg/0.6ml per dose and one dose of placebo
Arm Title
Four doses of placebo
Arm Type
Placebo Comparator
Arm Description
four doses of placebo
Intervention Type
Biological
Intervention Name(s)
Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
Intervention Type
Biological
Intervention Name(s)
Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
Intervention Type
Biological
Intervention Name(s)
High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Occurrence of injection site adverse reactions after vaccination
Description
Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time Frame
within 21 days after the vaccination
Title
Occurrence of systematic adverse reactions after vaccination
Description
Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time Frame
within 21 days after the vaccination
Secondary Outcome Measure Information:
Title
Occurrence of unsolicited adverse reactions after vaccination.
Description
Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time Frame
within 42 days after the vaccination
Title
Occurrence of serious adverse events after the vaccination.
Description
Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine
Time Frame
within 6 months after the vaccination
Title
Changes of the blood routine after vaccination.
Description
Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
Time Frame
day 0-17 after the vaccination
Title
Changes of the blood biochemistry after vaccination.
Description
Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
Time Frame
day 0-17 after the vaccination
Title
Geometric mean titre against specific antigens
Description
Geometric mean titre measured at day 0, 7, 14, 21, 42 and month 3, 6.
Time Frame
within 6 months after the vaccination
Title
Geometric mean fold increase against specific antigens
Description
Geometric mean fold increase measured at day 7, 14, 21, 42 and month 3, 6.
Time Frame
within 6 months after the vaccination
Title
Positive conversion rate of serum against specific antigens
Description
Positive conversion rate of serum measured at day 7, 14, 21, 42 and month 3, 6.
Time Frame
within 6 months after the vaccination
Other Pre-specified Outcome Measures:
Title
Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination.
Description
Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination with the Staphylococcus aureus vaccine at day at day 3, 7, 10, 14, 17, 21, 42 and month 3, 6.
Time Frame
within 6 months after the vaccination
Title
Specific functional antibody responses to the Staphylococcus aureus vaccine
Description
Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21, 42 and month 3, 6.
Time Frame
within 6 months after the vaccination
Title
Specific T cell immune responses to the Staphylococcus aureus vaccine.
Description
Specific T cell immune responses to the Staphylococcus aureus vaccine at day at day7, 14, 21, 42 and month 3, 6 measured by ELISpot.
Time Frame
within 6 months after the vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. 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. Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days. Current anti-tuberculosis prophylaxis or therapy Any other conditions may compromise the safety or availability of participants in the judgment of the investigator. Following Immunization exclusion standard: Any grade 3 or more serious adverse reaction happen since the last vaccination. Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization. Acute or chronic infections at the vaccination day (axillary temperature>37.0°C). According to the investigator, the participant should not continue participating in the study.
Facility Information:
Facility Name
Xiaokui Hu
City
Taixing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35473663
Citation
Zhu FC, Zeng H, Li JX, Wang B, Meng FY, Yang F, Gu J, Liang HY, Hu YM, Liu P, Peng LS, Hu XK, Zhuang Y, Fan M, Li HB, Tan ZM, Luo P, Zhang P, Chu K, Zhang JY, Zeng M, Zou QM. Evaluation of a recombinant five-antigen Staphylococcus aureus vaccine: The randomized, single-centre phase 1a/1b clinical trials. Vaccine. 2022 May 20;40(23):3216-3227. doi: 10.1016/j.vaccine.2022.04.034. Epub 2022 Apr 23.
Results Reference
derived

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

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