| Eligibility |
Inclusion Criteria:
1. Aged 18 to 65 years (included).
2. Able and willing to comply with all study requirements.
3. Willing to allow the investigators to discuss the volunteers' medical history with
his/her general practitioner/personal doctors and access all medical records which are
relevant to study procedures.
4. Healthy adults, or adults with stable medical condition who have a pre-existing
medical condition that does not meet any exclusion criteria. A stable medical
condition is defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 3 months before enrollment.
5. Have completed two doses vaccination by inactivated COVID-19 vaccine prior to the
study vaccination. The duration since the last primary vaccination is 90~365 days
(included) for both Phase II and Phase III stages.
6. For females of childbearing potential only, willing to practice continuous effective
contraception till 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 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.
7. Males participating in this study who are involved in heterosexual activity must agree
to practice adequate contraception (as described above) and refrain from donating
sperm till 90 days after receiving the study vaccination.
8. Agreement to refrain from blood donation during the study.
9. Provide written informed consent form (ICF) prior to study enrollment.
Exclusion Criteria:
1. Laboratory confirmed SARS-CoV-2 infection, defined by the result of SARS-CoV-2 RT-PCR
assay is positive.
2. Medical history of COVID-19 disease with confirmed clinical diagnosis.
3. Fever (oral temperature = 37.5°C / axillary temperature = 37.3°C) on the day of
vaccination. Or having fever within recent 72 hours before the vaccination.
4. Having abnormal results of clinical laboratory testing during screening, which is
judged by the investigator with clinical significance, including the hematology, liver
function, renal function, other blood chemistry, and coagulation function.
5. History of severe allergic disease or reactions likely to be exacerbated by any
component of ReCOV or COVID-19 Vaccine (Vero Cell), Inactivated, such as allergic
shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic 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., 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, respiratory disease (including
tuberculosis under anti-tuberculosis therapy), gastrointestinal disease, liver
disease, renal disease, hematology disease, endocrine disorder, psychiatric condition
and neurological illness (e.g., medical or family history of seizure, epilepsy,
encephalopathy). 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 other vaccines for emergency
use (e.g., to prevent tetanus and rabies) during the study.
14. Prior receipt of any investigational or licensed COVID-19 vaccine except for the
primary vaccination with inactivated vaccines according to the protocol, or plan to
receive any COVID-19 vaccine except for the investigational products 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 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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