A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster in People Aged 18-60 Years

WestVac Biopharma Co., Ltd.1 site in 1 country120 target enrollmentAugust 2, 2022

ConditionsCOVID-19 SARS-CoV-2 Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: WestVac Biopharma Co., Ltd.
Enrollment: 120
Locations: 1
Primary Endpoint: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.

A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated.

Registry

clinicaltrials.gov

Start Date

August 2, 2022

End Date

December 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

WestVac Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(1) Aged 18-60 years old, voluntarily sign the ICF approved by the ethics committee before any research procedure begins, and agree to participate in this research;
•(2) Subjects who are in line with the immunization of this product after medical history, physical examination and clinical judgment are healthy;
•(3) Participate in this clinical trial after completing 3 doses of immunization ≥ 6 months (calculated based on the date of the last vaccination as 0) in accordance with the domestically approved inactivated vaccine vaccination program, and can provide relevant vaccination certificates;
•(4) The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up of about 12 months;
•(5) Males and females of childbearing age who are fertile voluntarily use effective contraceptive measures (such as condoms, intrauterine devices, spermicides) from the signing of the informed letter to 6 months after the completion of vaccination, and contraceptive use is not allowed medicine. Female subjects had a negative pregnancy test and agreed not to breastfeed during the study period and for at least 3 months after vaccination with the experimental vaccine.
•(6) Underarm body temperature \<37.3℃.

Exclusion Criteria

•(1) Positive SARS-CoV-2 RT-PCR test at screening;
•(2) A history of human coronavirus infection or disease history such as novel coronavirus (SARS-CoV-2), severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS);
•(3) Those with previous medical history or family history of convulsions, epilepsy, encephalopathy or mental illness;
•(4) Persons with fainting needles;
•(5) Those who plan to become pregnant or perform sperm and egg donation during the trial period;
•(6) History of allergy or allergic reaction to any vaccine and its excipients, such as: allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc.;
•(7) Have received any vaccine within 30 days before vaccination of this research vaccine or plan to receive any other vaccine other than this research vaccine during this research;
•(8) Participate in any other interventional experimental device or drug research within 30 days before screening, or are currently using other experimental drugs or within 5 half-lives after the last administration of the research drug;
•(9) Hereditary bleeding tendency or abnormal coagulation function (such as cytokine deficiency, coagulation disorder or platelet disorder), or a history of severe bleeding, or a history of massive bleeding or ecchymosis after intramuscular injection or venipuncture;
•(10) According to known medical history or diagnosis, it is confirmed to have diseases that affect the function of the immune system, including cancer, congenital or acquired immunodeficiency (eg: human immunodeficiency virus (HIV) infection), uncontrolled autoimmune diseases;

Outcomes

Primary Outcomes

Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain

Time Frame: Day 30 post-boost dose.

Incidence of adverse drug reactions (ADRs)

Time Frame: Day 0-30 post-boost dose.

Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant

Time Frame: Day 30 post-boost dose.

Secondary Outcomes

Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant(Day 30 post-boost dose.)
GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD(Day 7, day 14, day 30, month 3 and month 6 after the booster dose.)
Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain(Day 30 post-boost dose.)
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain(Day 7, day 14, month 3 and month 6 after the booster dose.)
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant(Day 7, day 14, month 3 and month 6 after the booster dose.)