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Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102)

Primary Purpose

COVID-19

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant COVID-19 variant vaccine(Sf9 cell)
Recombinant COVID-19 vaccine(CHO 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 - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 and above. Obtain the subject's informed consent and sign the informed consent form. The subject is able and willing to comply with the requirements of the clinical trial protocol and is willing and able to comply with all study plan contents and other requirements of the study. Armpit body temperature < 37.3℃. People who have had basic or enhanced immunization with COVID-19 vaccine for 3 months or more; SARS-CoV-2 nucleic acid screening was negative in the last 24 hours. Anti-sars-cov-2 IgM antibody was negative during the screening period. BMI of 18.5-30.0 kg/m2. Women's non-pregnancy period (pregnancy test results are negative), non-lactation period. Fertile Women (WOCBP) subjects had taken effective contraceptive measures 1 month before enrollment. WOCBP subjects and male subjects, who do not plan to become pregnant for 6 months from the screening period to the last dose of immunization, agree to take effective contraceptive measures for 6 months from the screening visit to the last dose of immunization. WOCBP subjects and male subjects agree not to donate eggs (oocytes, oocytes) for assisted reproduction (WOCBP subjects) or to refrain from sperm donation (male subjects) for a period of 6 months from screening visit to the last dose of immunization. Subjects eligible for immunization with this product after medical history, physical examination and clinical judgment of health. Exclusion Criteria: Have cancer; Or have other serious chronic diseases such as uncontrolled asthma, diabetes, liver and kidney disease, thyroid disease, convulsions, epilepsy and other neurological/psychiatric disorders. have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune disease; Those who are allergic to any component of the experimental vaccine have had a history of severe vaccine allergic reaction in the past. History of SARS or MERS or SARS-CoV-2 infection/illness within 3 months. Patients with more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension that cannot be controlled by drugs. Congenital or acquired angioedema/neuroedema. Urticaria in the year prior to receiving the experimental vaccine. asplenia or functional asplenia. Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications). Needle fainter. Immunosuppressive therapy, antiallergy therapy, cytotoxic therapy, and inhaled corticosteroids (excluding corticosteroid spray for allergic rhinitis and topical corticosteroids for acute non-concurrent dermatitis) for 14 or more days within 6 months prior to receiving the experimental vaccine. Received blood products within 3 months prior to receiving the trial vaccine. Received other investigational drugs within 1 month prior to receiving the experimental vaccine. Received subunit or inactivated vaccine within 14 days or live attenuated vaccine within 1 month prior to receiving the experimental vaccine. are receiving anti-TB treatment. Medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.

Sites / Locations

  • Jiangsu Provincial Center for Disease Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

test group

control group

Arm Description

low dose and high dose, only one dose at day 0

one dose at day 0

Outcomes

Primary Outcome Measures

solicited adverse events (AE)
Incidence of solicited adverse events (AE)

Secondary Outcome Measures

laboratory safety
Changes in laboratory tests on day 3 after vaccination
safety outcome
Incidence of unsolicited adverse events (AE) and serious adverse events (SAE)
binding antibodies
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of S-RBD protein-specific antibodies (ELISA) against SARS-CoV-2
neutralizing antibodies
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strain)
cellular immune
ELISpot was used to detect the cell frequencies of IFN-γ and IL-2 secreted by SARS-CoV-2 S-RBD protein

Full Information

First Posted
March 10, 2023
Last Updated
May 4, 2023
Sponsor
WestVac Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05765604
Brief Title
Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102)
Official Title
A Randomized, Parallel Controlled, Double-blind, Single-center Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)(WSK-V102) in People Aged 18 Years or Older
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (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

5. Study Description

Brief Summary
Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.
Detailed Description
Low and high doses of study vaccine were compared with control groups to evaluate the safety and immunogenicity of the study vaccine.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test group
Arm Type
Experimental
Arm Description
low dose and high dose, only one dose at day 0
Arm Title
control group
Arm Type
Active Comparator
Arm Description
one dose at day 0
Intervention Type
Biological
Intervention Name(s)
Recombinant COVID-19 variant vaccine(Sf9 cell)
Intervention Description
IM
Intervention Type
Biological
Intervention Name(s)
Recombinant COVID-19 vaccine(CHO cell)
Intervention Description
IM
Primary Outcome Measure Information:
Title
solicited adverse events (AE)
Description
Incidence of solicited adverse events (AE)
Time Frame
0-14 days after vaccination
Secondary Outcome Measure Information:
Title
laboratory safety
Description
Changes in laboratory tests on day 3 after vaccination
Time Frame
3 days after vaccination
Title
safety outcome
Description
Incidence of unsolicited adverse events (AE) and serious adverse events (SAE)
Time Frame
30 days after vaccination,12 months after vaccination
Title
binding antibodies
Description
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of S-RBD protein-specific antibodies (ELISA) against SARS-CoV-2
Time Frame
14 days, 30 days, 3 months and 6 months
Title
neutralizing antibodies
Description
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strain)
Time Frame
14 days, 30 days, 3 months and 6 months
Title
cellular immune
Description
ELISpot was used to detect the cell frequencies of IFN-γ and IL-2 secreted by SARS-CoV-2 S-RBD protein
Time Frame
14 days and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 and above. Obtain the subject's informed consent and sign the informed consent form. The subject is able and willing to comply with the requirements of the clinical trial protocol and is willing and able to comply with all study plan contents and other requirements of the study. Armpit body temperature < 37.3℃. People who have had basic or enhanced immunization with COVID-19 vaccine for 3 months or more; SARS-CoV-2 nucleic acid screening was negative in the last 24 hours. Anti-sars-cov-2 IgM antibody was negative during the screening period. BMI of 18.5-30.0 kg/m2. Women's non-pregnancy period (pregnancy test results are negative), non-lactation period. Fertile Women (WOCBP) subjects had taken effective contraceptive measures 1 month before enrollment. WOCBP subjects and male subjects, who do not plan to become pregnant for 6 months from the screening period to the last dose of immunization, agree to take effective contraceptive measures for 6 months from the screening visit to the last dose of immunization. WOCBP subjects and male subjects agree not to donate eggs (oocytes, oocytes) for assisted reproduction (WOCBP subjects) or to refrain from sperm donation (male subjects) for a period of 6 months from screening visit to the last dose of immunization. Subjects eligible for immunization with this product after medical history, physical examination and clinical judgment of health. Exclusion Criteria: Have cancer; Or have other serious chronic diseases such as uncontrolled asthma, diabetes, liver and kidney disease, thyroid disease, convulsions, epilepsy and other neurological/psychiatric disorders. have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune disease; Those who are allergic to any component of the experimental vaccine have had a history of severe vaccine allergic reaction in the past. History of SARS or MERS or SARS-CoV-2 infection/illness within 3 months. Patients with more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension that cannot be controlled by drugs. Congenital or acquired angioedema/neuroedema. Urticaria in the year prior to receiving the experimental vaccine. asplenia or functional asplenia. Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications). Needle fainter. Immunosuppressive therapy, antiallergy therapy, cytotoxic therapy, and inhaled corticosteroids (excluding corticosteroid spray for allergic rhinitis and topical corticosteroids for acute non-concurrent dermatitis) for 14 or more days within 6 months prior to receiving the experimental vaccine. Received blood products within 3 months prior to receiving the trial vaccine. Received other investigational drugs within 1 month prior to receiving the experimental vaccine. Received subunit or inactivated vaccine within 14 days or live attenuated vaccine within 1 month prior to receiving the experimental vaccine. are receiving anti-TB treatment. Medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Control
City
Taizhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102)

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