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

WestVac Biopharma Co., Ltd.1 site in 1 country450 target enrollmentMarch 30, 2023

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: WestVac Biopharma Co., Ltd.
Enrollment: 450
Locations: 1
Primary Endpoint: Primary Immunogenic indicator
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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)

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) .

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

April 9, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

WestVac Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;