A observer-blind, randomized, controlled, investigator-initiated clinical trial toevaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 dosesvaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 monthsprior to enrolment. The study uses a non-inferiority design to compare between scheduleswith Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell)Inactivated as the booster dose. Participants, laboratory and analysing statisticianswill remain blind to treatment allocation.A total of 120 participants will be enrolled, participants will be randomized 1:1 toreceive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19Vaccine (Vero Cell), Inactivated.
Not Provided
Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)
1dose, Intramuscular Injection
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
1dose, Intramuscular Injection
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;
- (11) There are serious or uncontrollable diseases of the respiratory system,
cardiovascular diseases, nervous system diseases, blood and lymphatic system
diseases, liver and kidney diseases, metabolic and skeletal diseases that are judged
by the investigator to affect the evaluation of the results of this study;
- (12) Asplenia or functional asplenia;
- (13) Long-term use (≥14 days of continuous use) of immunosuppressive drugs or other
immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within
6 months before the vaccine for this trial, but topical drugs are allowed ( Such as
ointment, eye drops, inhalation or nasal spray), topical application should not
exceed the dose recommended in the instructions or have any signs of systemic
exposure;
- (14) Received immunoglobulin and/or blood products within 3 months before the
vaccine for this trial;
- (15) Patients undergoing anti-tuberculosis treatment;
- (16) According to the judgment of the investigator, due to various medical,
psychological, social or other conditions, it is contrary to the experimental
protocol, or affects the subject's signing of informed consent.
West China Hospital of Sichuan University
Chengdu 1815286, Sichuan 1794299, China
Not Provided