This is a non-randomized, open-label, externally controlled study to evaluate the safetyand immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated inpopulation aged 18 years old and above with no vaccination history of the COVID-19vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59years old and 50 aged 60 years old and above. All subjects will be received 2 doses ofOmicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization scheduleof 0, 21-28 days. The change in neutralizing antibody level at 28 days after the seconddose was used to determine whether to receive a further booster dose for ≥3 months.The occurrence of adverse events within 28 days and serious adverse events within 6months after vaccination will be observed. In addition, blood samples will be collectedon Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 andmonth 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will beanalyzed.
Not Provided
Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
2 doses of vaccine according to the immunization schedule of 0, 21-28 days
Inclusion Criteria:
- Healthy subjects aged 18 years old and above.
- By asking for medical history and physical examination, the investigator judged -
that the health condition is well.
- Female subjects of childbearing age are not nursing or pregnant at the time of
enrolment (negative urine pregnancy test) and have no family planning within the
first 12 months after enrolment. Effective contraceptive measures have been taken
within 2 weeks before inclusion.
- During the whole follow-up period of the study, be able and willing to complete the
whole prescribed study plan.
- With self-ability to understand the study procedures, the informed consent &
voluntarily sign an informed consent form and be able to comply with the
requirements of the clinical study protocol.
Exclusion Criteria:
- Confirmed or suspected cases of SARS-CoV-2 Infection.
- Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
- Has received COVID-19 vaccine (include mRNA, recombinant protein vaccines, vector
vaccines, inactivated vaccines, etc.)
- Axillary body temperature > 37.3 ℃ before vaccination
- Previous severe allergic reactions to vaccination (such as acute allergic reactions,
urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known
ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site
inquiry).
- History of hospital-diagnosed thrombocytopenia or other coagulation disorder
- Known immunological impairment or low level with hospital diagnosis
- History of uncontrolled epilepsy, other progressive neurological disorders, or
Guillain-Barre syndrome (self-report, on-site inquiry).
- Known or suspected concomitant serious diseases include: respiratory disease, acute
infection or active chronic disease, liver and kidney disease, severe diabetes,
malignant tumor, infection or allergic skin disease, HIV infection.
- Severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension,
etc.) diagnosed by the hospital, active chronic respiratory disease
- Live attenuated vaccine is inoculated within 1 month before this vaccination
- other vaccines are inoculated within 14 days before this vaccination.
- be participating in or plan to participate in other vaccine clinical trials during
this study.
- Contraindications related to vaccination as considered by other investigators.
Shulan (hangzhou) Hospital
Hangzhou, Zhejiang, China
Lanjuan Li, Principal Investigator
Shulan (Hangzhou) Hospital