- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770180
Phase II Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
April 22, 2024 updated by: WestVac Biopharma Co., Ltd.
A Single-center, Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Booster Vaccination of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) in Healthy People Aged 18 Years and Older
A single-center, randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of booster vaccination of Recombinant COVID-19 variant vaccine (Sf9 cell) in healthy people aged 18 years and older after completing 2 or 3 doses of novel coronavirus inactivated vaccine (Vero cells)
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
two dose level of Recombinant COVID-19 variant vaccine (Sf9 cell) compete with Recombinant COVID-19 vaccine (CHO cell) and Recombinant COVID-19 vaccine (Sf9 cell) .
Study Type
Interventional
Enrollment (Actual)
450
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nanjing, China
- Jiangsu Provincial Center for Disease Prevention and Control
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- At the age of 18 or above, consent to participate in the study by voluntarily signing an ICF approved by the Ethics Committee prior to the commencement of any study procedure;
- Subjects qualified for immunization with this product after medical history, physical examination and clinical judgment of health;
- Completion of 2 /3 doses of inactivated novel coronavirus vaccine ≥3 months;
- The subject is able and willing to comply with the requirements of the clinical trial protocol and can complete the study follow-up for approximately 12 months;
- Armpit body temperature < 37.3℃;
- Female 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 have no pregnancy plans from the screening period to 6 months after the last dose of immunization, and agree to take effective contraceptive measures from the screening visit to 6 months after 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.
Exclusion Criteria:
- Positive results of SARS-CoV-2 RT-PCR within 24 hours;
- The subject has a history of SARS-CoV-2 infection within 3 months;
- The anti-SARS-CoV-2 IgM antibody was positive during the screening period.
- History of human coronavirus infection or disease with severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS), etc.;
- Previous history of convulsion, epilepsy, encephalopathy or psychosis or family history;
- Needle fainter;
- Those who plan to become pregnant or donate sperm or eggs during the trial period (within 6 months after exemption);
- Previous history of allergic reaction or allergic reaction to any vaccine and its excipients, such as allergy, urticaria, severe eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
- Received subunit or inactivated vaccine within 14 days or live attenuated vaccine within 1 month prior to receiving the experimental vaccine;
- Participating in any other interventional test device or drug study within 30 days prior to screening, or currently using another investigational drug or within 5 half-life after the last administration of the study drug;
- A genetic tendency to hemorrhage or coagulation abnormalities (such as cytokine defects, coagulation disorders or platelet disorders), or a history of severe bleeding, or a history of excessive bleeding or ecchymosis following intramuscular injection or venipuncture;
- Confirmation of diseases affecting the functioning of the immune system, including cancer, congenital or acquired immunodeficiency (e.g., human immunodeficiency virus (HIV) infection), uncontrolled autoimmune diseases, based on known medical history or diagnosis;
- There are serious or uncontrollable respiratory diseases, cardiovascular diseases, nervous system diseases, blood and lymphatic system diseases, liver and kidney diseases, metabolic and skeletal system diseases that affect the evaluation of the results of this study as determined by the researchers;
- Anplenia or functional anplenia;
- Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within the 6 months prior to the study vaccine, but topical use (such as ointment, eye drops, inhalants or nasal spray) is permitted, and the topical use shall not exceed the dosage recommended in the instructions or any systemic signs of exposure;
- Received immunoglobulin and/or blood products in the three months prior to receiving the study vaccine;
- Patients undergoing anti-tuberculosis 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low dose test group
one dose, Day 0
|
WSK-V102
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Experimental: high dose test group
one dose, Day 0
|
WSK-V102
|
Active Comparator: control group 1
one dose, Day 0
|
control 1
|
Active Comparator: control group 2
one dose, Day 0
|
control 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
solicited adverse events (AE)
Time Frame: within 14 days after vaccination
|
Incidence of solicited adverse events (AE) within 14 days after vaccination
|
within 14 days after vaccination
|
Primary Immunogenic indicator
Time Frame: 14 days after vaccination
|
Geometric Mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 Prototype and Omicron Variant 14 days after vaccination
|
14 days after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
unsolicited adverse events
Time Frame: 0-30 days after vaccination
|
Incidence of unsolicited adverse events (AE) 0-30 days after vaccination
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0-30 days after vaccination
|
SAE
Time Frame: within 12 months after vaccination
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Incidence of serious adverse events (SAE), adverse events of Special Concern (AESI), and adverse events requiring medical attention (MAAE) within 12 months after vaccination
|
within 12 months after vaccination
|
GMT
Time Frame: 30 days, 3 months and 6 months after vaccination
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Geometric mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 prototype Strain and Omicron Variant Strain
|
30 days, 3 months and 6 months after vaccination
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GMI
Time Frame: 14, day 30, 3 and 6 months after vaccination
|
Geometric mean growth multiple (GMI) of neutralizing antibody against SARS-CoV-2 prototype strain
|
14, day 30, 3 and 6 months after vaccination
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binding antibodies
Time Frame: 14, day 30, 3 and 6 months after vaccination
|
Geometric Mean Titer (GMT) and Geometric mean Titer Increase Factor (GMI) of IgG Antibody against SARS-CoV-2 S-RBD protein
|
14, day 30, 3 and 6 months after vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2023
Primary Completion (Actual)
July 30, 2023
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 10, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WSKCT002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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