| Eligibility |
Inclusion Criteria:
1. Aged 18 to 60 years (included) at screening.
2. Have a body mass index (BMI) between 18.5 and 35.0 kg/m2 (included)
3. Able and willing to comply with all study requirements.
4. Willing to allow the Investigator to discuss the volunteers'participant's medical
history with his/her general practitioner/personal doctors and access all medical
records which are relevant to study procedures.
5. Participants who are of general good health, or with medically stable, well-controlled
comorbidities according to the Investigator's assessment, based on medical history at
the time of screening and clinical evaluations.
6. Have completed three doses vaccination by any mRNA COVID-19 vaccine 3~12 months
(90~365 days, included) prior to the study vaccination.
7. Females of childbearing potential who are involved in heterosexual sexual activity,
must be willing to practice continuous effective contraception until 90 days after the
study vaccination and have negative pregnancy tests before study vaccination.
- Nonchildbearing potential is defined as surgically sterile (history of bilateral
tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined
as amenorrhea for = 12 consecutive months prior to Screening without an
alternative medical cause). A follicle-stimulating hormone (FSH) level may be
measured at the discretion of the Investigator to confirm postmenopausal status.
- The effective contraceptive methods include sexual abstinence or adequate
contraceptive measures such as intrauterine or implanted contraceptive device,
oral contraceptives, injected or implanted contraceptives, sustained-release
topical contraceptives, condoms (male), diaphragm, and cervical cap, etc.
8. Males participating in this study who are involved in heterosexual sexual activity
must agree to practice adequate contraception (as described above) and refrain from
donating sperm until 90 days after the study vaccination.
9. Agreement to refrain from blood donation during the study from time of informed
consent until end of study visit.
10. Provide written informed consent form (ICF) prior to any study screening activity.
Exclusion Criteria:
1. Laboratory confirmed SARS-CoV-2 infection (history), defined by the result of
SARS-CoV-2 RT-PCR assay is positive, and/or SARS-CoV-2 nucleocapsid protein antibody
is positive.
2. Documented medical history of COVID-19 disease.
3. Fever (oral temperature = 37.5°C / axillary temperature = 37.3°C) on the day of
vaccination. Or having fever within 72 hours before the vaccination.
4. Having abnormal results of clinical laboratory testing during screening, which is
judged by the Investigator to be clinically significant, including hematology,
clinical chemistry, urinalysis, and coagulation.
5. History of severe allergic disease or reactions likely to be exacerbated by any
component of investigational vaccine, such as allergic shock, allergic laryngeal
edema, allergic purpura, thrombocytopenic purpura, local hypersensitive necrosis
reaction (Arthus reaction), prior history of serious adverse reaction to any vaccine
or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema.
6. Having malignant tumor (except for skin basal cell carcinoma or carcinoma uterine
cervix in situ), immune disease (e.g., documented human immunodeficiency virus [HIV]
infection, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy,
and other immune disease that may influence immune response at the Investigator's
discretion).
7. Having severe and/or uncontrolled conditions, including but not limited to, acute
infectious disease, cardiovascular disease (including history of myocarditis or
pericarditis), respiratory disease, gastrointestinal disease, liver disease, renal
disease, hematology disease, endocrine disorder, psychiatric condition and
neurological illness. Mild/moderate well-controlled comorbidities are allowed to
participate.
8. Having bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder),
or prior history of significant bleeding or bruising following intramuscular
injections or venipuncture.
9. Received immunosuppressant or other immunomodulators, antiallergic therapy, or
cytotoxicity therapy for 14 or more consecutive days within 6 months before the study
vaccination. Local administration of immunosuppressant or immunomodulator is allowed
(e.g., ointment, eye drops, inhalation, or nasal spray). Drugs for local
administration should not be given at a dose over the recommended level in package
insert or participants should have no signs of systemic exposure.
10. Administration of immunoglobulin and/or blood product within 3 months before the study
vaccination or plan to use that during the study.
11. Continuous use of anticoagulants, such as coumarins and related anticoagulants (e.g.,
warfarin) or novel oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran and
edoxaban).
12. Used other investigational drug or interventional device within 1 month before the
study vaccination or plan to use that during the study, or are using other
investigational drug or are within 5 half-lives after the last dose of the
investigational drug.
13. Used a subunit or inactivated vaccine within 14 days or an attenuated live vaccine
within 1 month (30 days) before the study vaccination, or plan to receive any other
vaccines except for the seasonal influenza vaccine, or emergency use authorized
vaccines during the study.
14. Prior receipt of any investigational or licensed COVID-19 vaccine except for the mRNA
vaccines according to the protocol, or plan to receive any COVID-19 vaccine except for
the investigational product (IP)s during the study stage.
15. Suspected or known current alcohol or drug dependency.
16. Having contraindications for intramuscular injection or intravenous blood sampling.
17. Pregnancy, lactation or plan to become pregnant within 90 days after receiving study
vaccine.
18. Staff of study site, sponsor, and contract research organization (CRO) taking part in
study conduct.
19. At the Investigator's discretion, any other significant disease, disorder or finding
that may increase the risk because of participation in the study, or prevent from
participation in the study, or impair interpretation of the study data.
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