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

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ClinicalTrials.gov Identifier: NCT05013983
Recruitment Status : Not yet recruiting
First Posted : August 20, 2021
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
WestVac Biopharma Co., Ltd.

Study Description
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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).

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant COVID-19 vaccine (Sf9 cells) Other: Placebo control Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : March 7, 2022
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: 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
Experimental: 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.
 Biological: 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
Experimental: 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.
 Biological: 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
Experimental: 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.
 Biological: 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
Placebo Comparator: Low-dose placebo (6-11 years)
three doses of low-dose placebo at the schedule of day 0, 21，42.
 Other: Placebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
Placebo Comparator: Medium-dose placebo (6-11 years)
three doses of medium-dose placebo at the schedule of day 0, 21，42.
 Other: Placebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
Placebo Comparator: Medium-dose placebo (12-17 years)
three doses of medium-dose placebo at the schedule of day 0, 21，42.
 Other: Placebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
Placebo Comparator: High-dose placebo (12-17 years)
three doses of high-dose placebo at the schedule of day 0, 21，42.
 Other: Placebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 the S-RBD protein-specific IgG antibody against SARS-CoV-2.

  4. 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 Outcome Measures :
  1. Phase I/II clinical trial：The incidence of adverse events (AEs) [ Time Frame: Day 0-7 days after each vaccination. ]
    Adverse events (AEs) in 0-7 days after each vaccination.

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

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

  4. Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants. [ Time Frame: Day 0 to 12 months after completion of 3 doses vaccination ]
    The incidence of serious adverse events(SAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants.

  5. Phase I clinical trial：Changes in laboratory test indicators [ Time Frame: 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）

  6. Phase I clinical trial：The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody [ Time Frame: 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.

  7. Phase I clinical trial：The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody. [ Time Frame: 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.

  8. Phase I clinical trial：the geometric mean increase multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody. [ Time Frame: 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.

  9. Phase I clinical trial：The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody [ Time Frame: 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.

  10. Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody [ Time Frame: 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

  11. Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05013983


Contacts
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Contact: Si yue Jia, PhD +86 17826065671 462371198@qq.com
Contact: Hongxing Pan, Dortor +86 18118996996 panhongxing@126.com

Locations
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China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009
Contact: Siyue Jia, PhD    +86 17826065671    462371198@qq.com   
Principal Investigator: Fengcai Zhu, Doctor         
Sponsors and Collaborators
WestVac Biopharma Co., Ltd.
West China Hospital
Investigators
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Principal Investigator: Fengcai Zhu Jiangsu Provincial Center for Disease Control and Prevention
More Information
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Responsible Party: WestVac Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05013983    
Other Study ID Numbers: JSVCT125
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by WestVac Biopharma Co., Ltd.:
Safety
Immunogenicity
COVID-19 Vaccine
Recombinant vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases