Clinical trial NCT03966040: A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Staphylococcus Aureus Infection
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Chengdu Olymvax Biopharmaceuticals Inc.
name: PLA Army Medical University
First posted: 2019-05-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of solicited adverse reactions after vaccination
timeFrame: within 21 days after vaccination
Secondary outcomes:
measure: Occurrence of unsolicited adverse reactions after vaccination
timeFrame: within 42 days after the vaccination
measure: Occurrence of serious adverse events after the vaccination.
timeFrame: within 6 months after the vaccination
measure: Changes of the blood routine after vaccination.
timeFrame: within 17 days after the vaccination
measure: Changes of the blood biochemistry after vaccination.
timeFrame: within 17 days after the vaccination
measure: Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine
timeFrame: within 42 days after vaccianation
measure: Specific functional antibody responses to the Staphylococcus aureus vaccine
timeFrame: within 42 days after vaccianation
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Suining County Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu, China
name: Fangyue Meng, Master
role: STUDY_DIRECTOR
References:
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.
citation: 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.