This clinical trial adopts a randomized, double-blind and placebo-controlled design.A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months willbe randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine,BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine orBIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.
Not Provided
Biological: LIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Biological: BIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Biological: placebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Inclusion Criteria:
- Age range: healthy population aged ≥18;
- Judged by the investigator that the health condition is well after inquiry and
physical examination;
- Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for
≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with
≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
- Be able and willing to complete all prescribed study schedules during the whole
study period;
- The participant himself/herself is able and willing to understand study procedures,
sign the informed consent form voluntarily after informed consent and comply to
requirements of the study protocol.
Exclusion Criteria:
- Symptomatic and suspected COVID 19 infection positive ;
- Urine pregnancy test is positive; Women of childbearing age who have positive urine
pregnancy test, who are pregnant, lactating, or women who have planned pregnancy
within 6 months;
- Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature
≥37.8℃);
- Previous allergy history of vaccine vaccination (such as acute allergic reaction,
urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or
allergy to known components of COVID-19 vaccine;
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation
disorders;
- With known immunological impairment or compromised immunological function diagnosed
by the hospital;
- Received whole blood, plasma and immunoglobulin therapy within 1 month;
- Known or suspected of suffering from the following diseases: acute or chronic active
respiratory diseases, severe cardiovascular diseases [cardiopulmonary failure,
hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or
diastolic blood pressure ≥ 95 mmHg)], acute infection, active phase of chronic
disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious
skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be
provided)
- Received live attenuated vaccine within one month before vaccination;
- Received inactivated vaccine within 14 days before vaccination;
- Other contraindications related to vaccination that investigators believe.
Sheikh Khalifa Medical City
Seha, Abu Dhab, United Arab Emirates
Investigator: Yunkai Yang, Prof.
Contact: +8613601126881
yangyunkai@sinopharm.com
Not Provided