Official Title
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
Brief Summary

This is randomized, blinded and controlled design. Among the randomly selected subjectswho have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell),based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19vaccine sequentially at different shedules of 1-3 months, 3-6 months and ≥ 6 months aftertwo doses of vaccination, and the subjects vaccinated at different schedules will berandomly assigned to different sequential immunization groups. At the same time, eachsequential immunization group will be matched with a control group with the inactivatedCOVID-19 vaccine (vero cells) as the booster dose.

Detailed Description

Not Provided

Unknown status
COVID-19 Pneumonia
Coronavirus Infections

Biological: Recombinant COVID-19 Vaccine (CHO cell)

Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle
of the upper arm

Biological: COVID-19 vaccine (Vero cells)

Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid
muscle of the upper arm

Eligibility Criteria

Inclusion Criteria:

- Age range: populations aged 18 years and above;

- Judged by the investigator that the health condition is well after inquiry and
physical examination;

- Vaccinated with 2 doses of CNBG inactivated COVID-19 vaccine according to the
product insert;

- Female subjects who are not nursing or pregnant at the time of enrolment (negative
urine pregnancy test) and have no family planning within the first 6 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; Self has ability to understand the study procedures,
the informed consent & voluntarily sign an informed consent form and is able to
comply with the requirements of the clinical study protocol.

Exclusion Criteria:

- Confirmed cases, suspected cases or asymptomatic cases of COVID-19;

- With a history of SARS and MERS infection (self-report, on-site inquiry);

- Has vaccinated with any vaccine other than one or more doses of CNBG inactivated
COVID-19 vaccine;

- Axillary temperature ≥ 37.3 ℃ (forehead temperature ≥ 37.8 ℃);

- Previous severe allergic reactions to vaccination (such as acute allergic reactions,
urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known
components of recombinant COVID-19 vaccine;

- Allergic to any component of the study vaccine (e.g. aluminum, histidine, etc.)

- Known or suspected diseases include:Severe respiratory diseases, severe liver and
kidney diseases, hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood
pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute
diseases or acute attacks of chronic diseases;

- Has been diagnosed with congenital or acquired immunodeficiency, HIV infection,
lymphoma, leukemia or other autoimmune diseases;

- Has a history of convulsions, epilepsy, encephalopathy,long term history of alcohol
and drug abuse, history of thyroidectomy, infectious diseasesor mental illness or
family history(lineal);

- With Congenital malformation or developmental disorder, genetic defect, severe
malnutrition, etc.;

- Has a history of coagulation dysfunction (e.g. coagulation factors deficiency and
coagulation diseases);

- Absence of spleen or splenectomy, functional absence of spleen caused by any
condition

- Anti -TB (TB) treatment is under way.

- Patients receiving immunoenhancement or inhibitor therapy within 3 months
(continuous oral or IV administration for more than 14 days);

- Received other vaccines within 14 days before vaccination;

- Received blood products before within 3 months before vaccination;

- Received other investigational drugs within 6 months before vaccination;

- Plan to move before the end of the study or leave the local area for a long time
during the scheduled study visit

- Other circumstances judged by investigators that are not suitable for this clinical
trial

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Arab Emirates
Locations

Sheikh Khalifa Medical City
Seha, Abu Dhab, United Arab Emirates

Not Provided

National Vaccine and Serum Institute, China
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19
Coronavirus Infections
Vaccines