CompletedNCT03966040Updated Mar 30, 2021

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

A Phase 1 interventional study of Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7 and Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 in Staphylococcus Aureus Infection, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 144
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Staphylococcus Aureus Infection

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In context

Staphylococcal Infections

273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's enrollment of 144 is above the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 144 participants (actual)

Study arms

Experimental
Immunization schedule of day 0-3-7
Three doses of schedule given at day 0, 3 and 7.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
Experimental
Immunization schedule of day 0/0-3-7
Four doses of schedule given at day 0/0, 3 and 7.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
Experimental
Immunization schedule of day 0/0-7
Three doses of schedule given at day 0/0 and 7.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
Experimental
Immunization schedule of day 0/0-7-14
Four doses of schedule given at day 0/0, 7 and 14.
Biological: Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14

Interventions

BiologicalInoculate 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
BiologicalInoculate 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
BiologicalInoculate 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
BiologicalInoculate 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

What researchers measure

Primary outcomes

Occurrence of solicited adverse reactions after vaccination
Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant
Time frame: within 21 days after vaccination

Secondary outcomes

Occurrence of unsolicited adverse reactions after vaccination
Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time frame: within 42 days after the vaccination
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
Time frame: within 6 months after the vaccination
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.
Time frame: within 17 days after the vaccination
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.
Time frame: within 17 days after the vaccination
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.
Time frame: within 42 days after vaccianation
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
Time frame: within 42 days after vaccianation

Study locations

1 site

Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu 221000, China

References and documents

Publications

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. PubMed 35473663 ↗
Wei J, Cheng X, Zhang Y, Gao C, Wang Y, Peng Q, Luo P, Yang L, Zou Q, Zeng H, Gu J. Identification and application of a neutralizing epitope within alpha-hemolysin using human serum antibodies elicited by vaccination. Mol Immunol. 2021 Jul;135:45-52. doi: 10.1016/j.molimm.2021.03.028. Epub 2021 Apr 16. PubMed 33873093 ↗

Individual participant data

Plan to share: Yes — Deidentified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.

Supporting information: Study protocol, Sap, Analytic code

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03966040
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Collaborators: Chengdu Olymvax Biopharmaceuticals Inc., PLA Army Medical University
Responsible party: Sponsor
First posted: May 29, 2019
Start date: May 16, 2019
Primary completion: Dec 16, 2019
Completion: May 16, 2020
Last update: Mar 30, 2021

Study contacts

Fangyue Meng, Master

study director · Jiangsu, China

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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