Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years
Overview
- Phase
- Phase 1
- Intervention
- Recombinant COVID-19 vaccine (Sf9 cells)
- Conditions
- COVID-19
- Sponsor
- WestVac Biopharma Co., Ltd.
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Phase I clinical trial：The incidence of adverse reactions (ARs) .
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
Low-dose vaccine (6-11 years)
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
Intervention: Recombinant COVID-19 vaccine (Sf9 cells)
Medium-dose vaccine (6-11 years)
three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
Intervention: Recombinant COVID-19 vaccine (Sf9 cells)
Medium-dose vaccine (12-17 years)
three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
Intervention: Recombinant COVID-19 vaccine (Sf9 cells)
High-dose vaccine (12-17 years)
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
Intervention: Recombinant COVID-19 vaccine (Sf9 cells)
High-dose placebo (12-17 years)
three doses of high-dose placebo at the schedule of day 0, 21，42.
Intervention: Placebo control
Low-dose placebo (6-11 years)
three doses of low-dose placebo at the schedule of day 0, 21，42.
Intervention: Placebo control
Medium-dose placebo (6-11 years)
three doses of medium-dose placebo at the schedule of day 0, 21，42.
Intervention: Placebo control
Medium-dose placebo (12-17 years)
three doses of medium-dose placebo at the schedule of day 0, 21，42.
Intervention: Placebo control
Outcomes
Primary Outcomes
Phase I clinical trial：The incidence of adverse reactions (ARs) .
Time Frame: 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) .
Time Frame: 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.
Time Frame: Day 30 after completion of 3 doses vaccination
The geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus).
Secondary Outcomes
- 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)
- 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)
- 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)
- Phase I clinical trial：Changes in laboratory test indicators(within 7 days before the first vaccination and on the 3rd day 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)
- Phase I/II clinical trial：The incidence of adverse events (AEs)(Day 0-7 days after each vaccination.)
- Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.(Day 0 to 12 months after completion of 3 doses vaccination)
- 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)
- 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)
- 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)