COVID-19
Conditions
Keywords
Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALRecombinant 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
OTHERPlacebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
Sponsors
West China Hospital
WestVac Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I clinical trial：The incidence of adverse reactions (ARs) . | Day 0-7 days after each vaccination. | Adverse reactions (ARs) in each dose group 0-7 days after each vaccination. |
| Phase II clinical trial：The incidence of adverse reactions (ARs) . | Day 0-7 days after each vaccination. | Adverse reactions (ARs) in 0-7 days after each vaccination. |
| Phase II clinical trial：The geometric mean titer(GMT) of specific antibody. | Day 30 after completion of 3 doses vaccination | The geometric mean titer (GMT) of the S-RBD protein-specific IgG antibody against SARS-CoV-2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I clinical trial：Changes in laboratory test indicators | within 7 days before the first vaccination and on the 3rd day after each vaccination | Changes in laboratory test indicators within 7 days before the first vaccination and on the 3rd day after each vaccination（Including white blood cell count, lymphocyte count, neutrophil count, platelets, hemoglobin, alanine aminotransferase ALT, aspartate aminotransferase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine Protein, urine red blood cells） |
| Phase I clinical trial：The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody | Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination | The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody (ELISA method) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination. |
| Phase I clinical trial：The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody. | Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination | The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody (ELISA method) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination. |
| Phase I/II clinical trial：The incidence of adverse events (AEs) | Day 0-7 days after each vaccination. | Adverse events (AEs) in 0-7 days after each vaccination. |
| Phase I clinical trial：The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody | Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination | The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination. |
| Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody | Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination | The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody on day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination |
| Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody | Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination | The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination. |
| Phase I clinical trial：the geometric mean increase multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody. | Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination | the geometric mean increase multiple (GMI) anti-COVID-19 S-RBD protein specific antibody (ELISA method) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination. |
| Phase I/II clinical trial：The incidence of adverse events (AEs) in all participants. | Day 0 to 30 days after completion of 3 doses vaccination | The incidence of adverse events (AEs) from Day 0 through 30 days after completion of 3 doses vaccination in all participants. |
| Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants. | Day 0 to 30 days after completion of 3 doses vaccination | The incidence of serious adverse events(SAEs) from Day 0 through 30 days after completion of 3 doses vaccination in all participants. |
Countries
China
Outcome results
None listed