Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and Adolescents

WestVac Biopharma Co., Ltd.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Conditions

COVID-19

Interventions

Recombinant COVID-19 vaccine (Sf9 cells)BIOLOGICAL

This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified

Placebo controlOTHER

Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Phase I clinical trial：The incidence of adverse reactions (ARs) .

Adverse reactions (ARs) in each dose group 0-7 days after each vaccination.

Time frame: Day 0-7 days after each vaccination.

Phase II clinical trial：The incidence of adverse reactions (ARs) .

Adverse reactions (ARs) in 0-7 days after each vaccination.

Time frame: Day 0-7 days after each vaccination.

Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.

The geometric mean titer (GMT) of the S-RBD protein-specific IgG antibody against SARS-CoV-2.

Time frame: Day 30 after completion of 3 doses vaccination

Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.

The geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus).

Time frame: Day 30 after completion of 3 doses vaccination

Secondary Outcomes

Phase I/II clinical trial：The incidence of adverse events (AEs)

Adverse events (AEs) in 0-7 days after each vaccination.

Time frame: Day 0-7 days after each vaccination.

Phase I/II clinical trial：The incidence of adverse events (AEs) in all participants.

The incidence of adverse events (AEs) from Day 0 through 30 days after completion of 3 doses vaccination in all participants.

Time frame: Day 0 to 30 days after completion of 3 doses vaccination

Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.

Data from ClinicalTrials.gov

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