Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells)

Study Overview
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Brief Summary
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This is a phase Ⅱb, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.

Detailed Description
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This is a phase Ⅱb, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.

Official Title
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A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Recombinant COVID-19 vaccine (Sf9 cells)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-85 years old Able to understand the content of informed consent and willing to sign the informed consent. Able and willing to complete all the secluded study process during the whole study follow-up period (about 14 months). Axillary temperature ≤37.0℃ Exclusion Criteria: Positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS-CoV-2. SARS-CoV-2 nucleic acid testing positive. History of SARS-CoV-2 infection or vaccination A Known History of HIV infection Family history of seizure, epilepsy, brain or mental disease. Participant that has an allergic history to any ingredient of vaccines. Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 14 months. Any acute fever disease or infections. Have a medical history of SARS. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled. Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled. Malignant tumor, activity or have been treated tumor and no clear have cured, or during the study period is likely to relapse. Hereditary angioneurotic edema or acquired angioneurotic edema. Urticaria in last one year. Asplenia or functional asplenia. Platelet disorder or other bleeding disorder may cause injection contraindication. Faint at the sight of blood or needles. Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months. Prior administration of blood products in last 4 months. Prior administration of other research medicines in last 1 month. Prior administration of attenuated vaccine in last 1 month. Prior administration of subunit vaccine or inactivated vaccine in last 14 days. Nearly 7 days, all sorts of acute onset of disease or chronic diseases, such as receiving anti-tuberculosis treatment, history of asthma. According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol or affects the subjects to sign informed consent. Exclusion criteria for subsequent doses: Appear systemic allergic reaction, severe allergic reactions. Appear difficult to tolerate more than grade 3 adverse reactions. New discovery or a new happened after the first vaccination does not conform to the first dose of the inclusion criteria or conform to the first dose of exclusion criteria, determine whether or not to continue to participate in the study by the investigators. Investigators think of other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adults group (aged 18-59 years) & vaccine<br>three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. | Biological: Recombinant COVID-19 vaccine (Sf9 cells)<br>* Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.<br>|
| Placebo Comparator: adults group (aged 18-59 years) & placebo<br>three doses of placebo at the schedule of day 0, 21, 42. | Biological: Placebo<br>* Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.<br>|
| Experimental: elderly adults group (aged 60-85 years) & vaccine<br>three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. | Biological: Recombinant COVID-19 vaccine (Sf9 cells)<br>* Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.<br>|
| Placebo Comparator: elderly adults group (aged 60-85 years) & placebo<br>three doses of placebo at the schedule of day 0, 21, 42. | Biological: Placebo<br>* Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse reaction (AR) | The incidence of adverse reaction (AR) | 0 to 7 days after each dose | 
| The incidence of Adverse Events of Special Interest (AESI) | The incidence of Adverse Events of Special Interest (AESI) | from day 0 to day 60 after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events (AE) | The incidence of adverse events (AE) | from day 0 to day 30 after last dose | 
| The incidence of grade 3 adverse events (AE) | The incidence of grade 3 adverse events (AE) | from day 0 to day 30 after last dose | 
| The incidence of severe adverse events (SAE) | The incidence of severe adverse events (SAE) | Month 12 after the whole process of vaccination | 
| Geometric mean (GMT) of specific antibody | Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) in immunogenicity subgroup. | day 30, day 60, month 6, month 12 after last dose | 
| Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies | Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays) | day 30, day 60, month 6, month 12 after last dose | 
| The positive conversion rate of S-RBD protein-specific antibody | The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2 | day 30, day 60, month 6, month 12 after last dose | 
| Geometric mean fold increase (GMI) of S-RBD protein-specific antibody | Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2 | day 30, day 60, month 6, month 12 after last dose | 
| The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody | The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test) | day 30, day 60, month 6, month 12 after last dose | 
| Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies | Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays) | day 30, day 60, month 6, month 12 after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine