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A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell)

Primary Purpose

COVID-19, SARS-CoV-2 Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Recombinant COVID-19 vaccine (Sf9 cell)
Sponsored by
WestVac Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects aged from 18-59 years.
  • Signed informed consent forms of the subjects have been obtained.
  • Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up.
  • Axillary temperature < 37.3℃. Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators.

Exclusion Criteria:

  • Positive SARS-CoV-2 antibodies (IgG or IgM) screening results.
  • Positive SARS-CoV-2 Antigen screening results.
  • History of COVID-19 vaccination.
  • Previously diagnosed with COVID-19 infection.
  • History of HIV infection.
  • History or family history of convulsion, epilepsy, encephalopathy and psychosis.
  • Allergy to any component of the candidate vaccine, severe allergy to vaccine in the past, and history of allergy.
  • Women with positive urine pregnancy test results, pregnant, lactating women, or women who have a pregnancy plan during the study.
  • Patients with acute febrile diseases and infectious diseases.
  • Patients with a history of SARS.
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc.
  • Serious chronic diseases or progressive stage of a disease that cannot be steadily controlled, such as asthma, diabetes mellitus, thyroid disease, etc.
  • Congenital or acquired angioedema/angioneurotic edema.
  • Urticaria 1 year before receiving the candidate vaccine.
  • Asplenia or functional asplenia.
  • Thrombocytopenia or other coagulation disorders (which may contraindicate intramuscular injection).
  • Fear of needles.
  • Any immunosuppressant, antiallergic therapy, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months.
  • Blood products within 4 months prior to receiving the candidate vaccine.
  • Any other investigational medicine(s) within 1 month prior to the candidate vaccine.
  • Any live attenuated vaccine within 1 month prior to the candidate vaccine.
  • Any subunit vaccine or inactivated vaccine within 14 days prior to the candidate vaccine.
  • Receiving antituberculosis treatment.
  • Medical, psychological, social or other factors, which in the discretion of the investigators fail to meet the requirements in the trial protocol or affect the subjects to sign the ICFs.

Exclusion criteria for the second/third dose:

In this trial, the second/third vaccination may be stopped in some cases. They include systemic allergic reaction, severe hypersensitivity, or intolerable Grade 3 or above ARs after the previous dose of vaccine. If these reactions occur, the subjects should not continue to receive the second/third vaccination.

Sites / Locations

  • Jiangsu Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilot batch

Commercial batch

Arm Description

Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42.

Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42.

Outcomes

Primary Outcome Measures

The incidence of adverse reactions(ARs).
The incidence of ARs within 7 days after each vaccination.
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.

Secondary Outcome Measures

The incidence of ARs.
The incidence of ARs from Day 0 to Day 72.
The incidence of adverse events (AEs).
The incidence of adverse events (AEs) from Day 0 to Day 72.
The incidence of serious adverse events (SAEs).
The incidence of SAEs from day 0 through 6 months after the third vaccination.
The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.
The GMI of the anti-SARS-COV-2 specific neutralizing antibody of the subjects on day 30 after the third vaccination.
The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody
The GMT, SCR and GMI of anti-SARS-COV-2 S-RBD IgG antibody of the subjects on day 30 after the third vaccination

Full Information

First Posted
February 13, 2022
Last Updated
July 19, 2022
Sponsor
WestVac Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05465785
Brief Title
A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell)
Official Title
A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WestVac Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
Detailed Description
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2 Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
892 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot batch
Arm Type
Experimental
Arm Description
Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42.
Arm Title
Commercial batch
Arm Type
Active Comparator
Arm Description
Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42.
Intervention Type
Biological
Intervention Name(s)
Recombinant COVID-19 vaccine (Sf9 cell)
Intervention Description
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
Primary Outcome Measure Information:
Title
The incidence of adverse reactions(ARs).
Description
The incidence of ARs within 7 days after each vaccination.
Time Frame
Day 0 to day 7
Title
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
Description
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.
Time Frame
Day 72
Secondary Outcome Measure Information:
Title
The incidence of ARs.
Description
The incidence of ARs from Day 0 to Day 72.
Time Frame
Day 0 to Day 72
Title
The incidence of adverse events (AEs).
Description
The incidence of adverse events (AEs) from Day 0 to Day 72.
Time Frame
Day 0 to Day 72
Title
The incidence of serious adverse events (SAEs).
Description
The incidence of SAEs from day 0 through 6 months after the third vaccination.
Time Frame
Day 0 to 6 months after the third vaccination.
Title
The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.
Description
The GMI of the anti-SARS-COV-2 specific neutralizing antibody of the subjects on day 30 after the third vaccination.
Time Frame
Day 72
Title
The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody
Description
The GMT, SCR and GMI of anti-SARS-COV-2 S-RBD IgG antibody of the subjects on day 30 after the third vaccination
Time Frame
Day 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects aged from 18-59 years. Signed informed consent forms of the subjects have been obtained. Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up. Axillary temperature < 37.3℃. Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators. Exclusion Criteria: Positive SARS-CoV-2 antibodies (IgG or IgM) screening results. Positive SARS-CoV-2 Antigen screening results. History of COVID-19 vaccination. Previously diagnosed with COVID-19 infection. History of HIV infection. History or family history of convulsion, epilepsy, encephalopathy and psychosis. Allergy to any component of the candidate vaccine, severe allergy to vaccine in the past, and history of allergy. Women with positive urine pregnancy test results, pregnant, lactating women, or women who have a pregnancy plan during the study. Patients with acute febrile diseases and infectious diseases. Patients with a history of SARS. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc. Serious chronic diseases or progressive stage of a disease that cannot be steadily controlled, such as asthma, diabetes mellitus, thyroid disease, etc. Congenital or acquired angioedema/angioneurotic edema. Urticaria 1 year before receiving the candidate vaccine. Asplenia or functional asplenia. Thrombocytopenia or other coagulation disorders (which may contraindicate intramuscular injection). Fear of needles. Any immunosuppressant, antiallergic therapy, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months. Blood products within 4 months prior to receiving the candidate vaccine. Any other investigational medicine(s) within 1 month prior to the candidate vaccine. Any live attenuated vaccine within 1 month prior to the candidate vaccine. Any subunit vaccine or inactivated vaccine within 14 days prior to the candidate vaccine. Receiving antituberculosis treatment. Medical, psychological, social or other factors, which in the discretion of the investigators fail to meet the requirements in the trial protocol or affect the subjects to sign the ICFs. Exclusion criteria for the second/third dose: In this trial, the second/third vaccination may be stopped in some cases. They include systemic allergic reaction, severe hypersensitivity, or intolerable Grade 3 or above ARs after the previous dose of vaccine. If these reactions occur, the subjects should not continue to receive the second/third vaccination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu feng cai, MD
Phone
86 025-83759529
Email
jszfc@vip.sina.com
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Control and Prevention
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu feng cai, MD
Phone
086 025-83759529
Email
jszfc@vip.sina.com

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell)

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