This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to
evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9
cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42
days and doses (10μg/20μg/40μg). The phase Ⅰ clinical trials designed 4 research group,
including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml,
40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 30 participants.
Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in
total. The phase Ⅱ clinical trials designed 4 research group, including immunization
procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages
group (6-11 and 12-17years): Each group including 120 participants. Vaccination or placebo
group will be randomly assigned to receive in a 2:1 ratio, 480 in total.
Biological: Recombinant COVID-19 vaccine (Sf9 cells)
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
Other: Placebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
Inclusion Criteria:
- Aged 6-17 years；
- The subject and/or guardian can understand and voluntarily sign the informed consent
form (double signature is required for 8-17 years old)；
- Reproductive women have a negative pregnancy test before each vaccination；
- The subjects are able and willing to comply with the requirements of the clinical
trial protocol, and can complete the study follow-up for approximately 13.5 months.
Exclusion Criteria:
- History of SARS-CoV-2 infection.
- The COVID-19 antibody (IgG and IgM) screening was positive.
- History of asthma, history of allergy to vaccines or vaccine components, or severe
adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema.
- Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Severe chronic diseases that cannot be controlled by drugs, severe cardiovascular
diseases, diabetes, liver and kidney diseases, malignant tumors, etc.
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
- Any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or
splenectomy.
- Diagnosis of abnormal blood clotting function (for example, lack of clotting factors,
coagulopathy, abnormal platelets) or obvious bruising or blood clotting.
- In the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled
corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and
superficial corticosteroid therapy for acute uncomplicated dermatitis).
- Laboratory test results with clinically significant abnormalities (severity level 2
and above) (applicable to phase I clinical trials only).
- Received blood products in the last 3 months.
- Receive other study drugs or vaccines within the past 30 days.
- Vaccination against live attenuated vaccines in the past 30 days.
- Inactivated vaccine or subunit vaccine in the past 14 days.
- Acute disease or acute exacerbation of chronic disease in the last 7 days.
- Axillary temperature> 37.0°C.
- According to the judgment of the investigator, the subject has other factors that are
not suitable for participating in the clinical trial.
Subsequent dose exclusion criteria:
In this trial, the second/third dose of vaccination may be stopped in some cases. This
includes allergic reactions, severe hypersensitivity reactions, or grade 3 or higher
adverse reactions that cannot be tolerated after previous vaccination/placebo. If these
reactions occur, the subject should not continue to receive the second/third vaccination.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Investigator: Siyue Jia, PhD
Contact: +86 17826065671
462371198@qq.com
Investigator: Fengcai Zhu, Doctor
Si yue Jia, PhD
+86 17826065671
462371198@qq.com
Hongxing Pan, Dortor
+86 18118996996
panhongxing@126.com
Fengcai Zhu, Principal Investigator
Jiangsu Provincial Center for Disease Control and Prevention