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

NCT ID: NCT05013983

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

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

Low-dose placebo (6-11 years)

three doses of low-dose placebo at the schedule of day 0, 21，42.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

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

Medium-dose placebo (6-11 years)

three doses of medium-dose placebo at the schedule of day 0, 21，42.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

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

Medium-dose placebo (12-17 years)

three doses of medium-dose placebo at the schedule of day 0, 21，42.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

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

High-dose placebo (12-17 years)

three doses of high-dose placebo at the schedule of day 0, 21，42.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BIOLOGICAL

Placebo control

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

Intervention Type: OTHER

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).
• 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.

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

WestVac Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengcai Zhu

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

JSVCT125

Identifier Type: -

Identifier Source: org_study_id