phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine(CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will beenrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70years old group, 9-17 years old group and 3-8 years old group. In each group, there aretwo regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. Thesubjects in regimen cohort will be randomized to receive vaccines or placebos at a ratioof 2:1.Phase II clinical study will explore dose and immunization procedures in 5 age groups,including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 yearsold group, and 3-8 years old group, with a total of 3280 subjects.
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Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the
deltoid muscle of the upper arm
Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) 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 people aged 3 years and and older who can provide legal
identification;
- The subject and/or his legal guardian and/or his entrusted person can understand the
study procedures and informed consent, voluntarily sign informed consent form, and
be able to comply with the requirements of the clinical study protocol;
- Inquired about medical history and physical examination, the investigator judged
that the health condition is good;
- No history of SARS-CoV-2 vaccination before enrollment;
- Females of childbearing age (menarche to menopause) are not pregnant at the time of
enrollment (negative urine pregnancy test), not breastfeeding, and have no birth
plan within 12 months after enrollment; effective contraception will be taken within
2 weeks before enrollment;
- During the entire study follow-up period, be able and willing to complete the entire
prescribed study plan.
Exclusion Criteria:
First Dose Exclusion Criteria:
- Confirmed cases of SARS-CoV-2 infection, suspected cases, asymptomatic infections,
or close contacts with the above population (check "China Disease Prevention and
Control Information System");
- Axillary body temperature is not less than 37.3℃ (older than 14 years) before
vaccination, and axillary body temperature is not less than 37.5℃ (14 years or
younger) before vaccination;
- Positive in SARS-CoV-2 IgG and IgM antibody screening;
- Have a history of SARS virus infection (self-report, on-site inquiry);
- Fever (axillary temperature is not less than 37.3℃), dry cough, fatigue, nasal,
congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, or
dyspnea within 14 days before vaccination;
- Before vaccination, the results of blood biochemistry, blood routine, urine routine,
and coagulation function related indexes are abnormal, which exceed the reference
value range, and have clinical significance abnormalities (only refers to phase I);
- Previous severe allergic reaction to vaccination (such as acute allergic reaction,
urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain);
- Allergic to any component of the study vaccine (such as aluminum, histidine, etc.);
- Have a history of convulsions, epilepsy, encephalopathy, long-term alcoholism and
drug abuse, thyroidectomy, infectious diseases, mental illness or family history;
- Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc;
- Known or suspected diseases include: severe respiratory disease, severe liver and
kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension
(systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not
less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors,
various acute diseases or acute attacks of chronic diseases;
- Have been diagnosed with congenital or acquired immunodeficiency, HIV infection,
lymphoma, leukemia or other autoimmune diseases;
- Have a history of abnormal coagulation function (such as coagulation factor
deficiency, coagulopathy);
- Asthenia or splenectomy, functional asthenia caused by any situation;
- Are receiving anti-TB (tuberculosis) treatment;
- Have received immune enhancement or inhibitor therapy within 3 months (continuous
oral or instillation for more than 14 days);
- Have received a live attenuated vaccine within 28 days before vaccination, or
received other vaccines within 14 days before vaccination;
- Have received blood products within 3 months before vaccination;
- Have received other study 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 conditions considered by the investigator to be inappropriate for
participation in the study.
Exclusion criteria for the second and third doses of vaccination
- Positive urine pregnancy test;
- Have a high fever (axillary temperature is not less than 39.0℃) for three days and
severe allergic reaction after the previous dose of vaccination;
- Severe adverse reactions that are causally related to the previous dose of
vaccination;
- For those newly discovered or newly identified after the previous dose of vaccine
that does not meet the first dose selection criteria or meets the first dose
exclusion criteria, the investigator will determine whether to continue
participating in the study;
- Other exclusion reasons considered by the investigator.
Ning ling Center for Disease Control and Prevention
Shang Qiu, He Nan, China
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