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

NCT05013983 | Withdrawn Phase 1 DMC

• 1 other identifier: JSVCT125
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Keywords

Safety; Immunogenicity; COVID-19 Vaccine; Recombinant vaccine

Outcome Measures

Primary Outcomes (4)

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

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

  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.

  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.

  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).

  Day 30 after completion of 3 doses vaccination

Secondary Outcomes (11)

• 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 adverse events (AEs) in all participants.

  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.

  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.

  Day 0 to 12 months 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

Study Arms (8)

Low-dose vaccine (6-11 years)

EXPERIMENTAL

three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.

Biological: Recombinant COVID-19 vaccine (Sf9 cells)

Medium-dose vaccine (6-11 years)

EXPERIMENTAL

three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.

Biological: Recombinant COVID-19 vaccine (Sf9 cells)

Medium-dose vaccine (12-17 years)

EXPERIMENTAL

three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.

Biological: Recombinant COVID-19 vaccine (Sf9 cells)

High-dose vaccine (12-17 years)

EXPERIMENTAL

three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.

Biological: Recombinant COVID-19 vaccine (Sf9 cells)

Low-dose placebo (6-11 years)

PLACEBO COMPARATOR

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

Other: Placebo control

Medium-dose placebo (6-11 years)

PLACEBO COMPARATOR

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

Other: Placebo control

Medium-dose placebo (12-17 years)

PLACEBO COMPARATOR

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

Other: Placebo control

High-dose placebo (12-17 years)

PLACEBO COMPARATOR

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

Other: Placebo control

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

High-dose vaccine (12-17 years); Low-dose vaccine (6-11 years); Medium-dose vaccine (12-17 years); Medium-dose vaccine (6-11 years)

Placebo control OTHER

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

High-dose placebo (12-17 years); Low-dose placebo (6-11 years); Medium-dose placebo (12-17 years); Medium-dose placebo (6-11 years)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead
• West China Hospital: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fengcai Zhu

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 20, 2021
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-03

Locations

CN (1)