A Study to Evaluate the Efficacy and Safety of SCTV01E (a Recombinant Protein COVID-19 Vaccine) in Population Aged ≥18 Years

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effectiveness of SCTV01E in participants aged ≥18 years.

Detailed Description
-----------------
The study is a randomized, double-blind, placebo-controlled Phase III study. It will evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in participants who were previously received primary series or booster dose of COVID-19 vaccines.

Official Title
-----------------
A Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E (Alpha/Beta/Delta/Omicron Variants S-Trimer COVID-19 Vaccine) in Population Aged ≥18 Years

Conditions
-----------------
COVID-19, SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Biological: SCTV01E
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged ≥18 years old when signing ICF; Participants who were fully vaccinated with COVID-19 vaccine and/or received booster vaccination, and the interval between the last dose of COVID-19 vaccine previously received and screening is 6 to 24 months; The participant and/or his/her legal representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial; The participant and/or his/her legal representative have the ability to read, understand, and fill in record cards; Healthy participants or participants with pre-existing medical conditions who are in stable condition. The pre-existing medical conditions include but not limited to hypertension, diabetes, Chronic cholecystitis and cholelithiasis, chronic gastritis that meet the described criteria. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment; Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the last dose of study vaccination; the pregnancy test results of women of childbearing potential are negative on screening. Exclusion Criteria: A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period; Presence of fever within 3 days before the study vaccination; A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema; A medical or family history of seizure, epilepsy, encephalopathy and psychosis; Immunocompromised patients suffering from immunodeficiency diseases, important organ diseases, immune diseases (including Guillain-Barre Syndrome [GBS], systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy caused by any circumstances, and other immune diseases that may have an impact on immune response in the investigator's opinion), etc.; Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed; Patients on antituberculosis therapy; Presence of severe or uncontrollable cardiovascular diseases, or severe or uncontrollable disorders related to endocrine system, blood and lymphatic system, liver and kidney, respiratory system, metabolic and skeletal systems, or malignancies (skin basal cell carcinoma and carcinoma in-situ of cervix are exceptions and will not be excluded), such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia; Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders; Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study; Participants who received other investigational drugs within 1 month before the study vaccination; Participants who is at the acute state of disease, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis; Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination; Those who donated blood or had blood loss (≥450 mL) within 3 months before the vaccination or plan to donate blood during the study period; Those who are pregnant or breast-feeding or plan to be pregnant during the study period; Those who plan to donate ovum or sperms during the study period; Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing; Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants; Those who are tested positive for HIV in terms of serology.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCTV01E<br>one dose of SCTV01E on D0 | Biological: SCTV01E<br>* D0; intramuscular injection<br>|
| Placebo Comparator: Placebo<br>one dose of Placebo on D0 | Biological: Placebo<br>* D0; intramuscular injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cases of the first occurrence of symptomatic COVID-19 of any severity starting 14 days (≥15 days) after the study vaccination |  | From Day 15 to Day 365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Cases of the first occurrence of SARS-CoV-2 infection, moderate and above COVID-19, severe and above COVID-19, hospitalization due to COVID-19, and death due to COVID-19, respectively, starting 14 days and 28 days after the study vaccination. |  | From Day 15 to Day 365 | 
| Cases of the first occurrence of symptomatic COVID-19 of any severity starting 28 days after the study vaccination |  | From Day 29 to Day 365 | 
| Eficacy: Cases of the first occurrence of symptomatic COVID-19 of any severity caused by different SARS-CoV-2 variants and subvariants starting 14 days and 28 days after the study vaccination. |  | From Day 15 to Day 365 | 
| Immunogenicity: GMT of nAb against SARS-CoV-2 (including its variants and subvariants) on on Day 7, Day 14, Day 28, Day 180 and Day 365. |  | 28 days after the study vaccination | 
| Immunogenicity: Seroresponse rate of nAb against SARS-CoV-2 (including its variants and subvariants) on Day 7, Day 14, Day 28, Day 180 and Day 365. |  | 28 days after the study vaccination | 
| Stage 1: Incidence and severity of solicited AEs of SCTV01E from D0 to D7 in Cohort 3. |  | Day 0 to Day 7 after the 1st study vaccination | 
| Safety: Incidence and severity of solicited AEs of SCTV01E from D0 to D7. |  | Day 0 to Day 7 after the study vaccination. | 
| Safety: Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28. |  | Day 0 to Day 28 after the study vaccination. | 
| Safety: Incidence and severity of SAEs and AESIs. |  | Day 0 to Day 365 after the study vaccination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-CoV-2 infection, Vaccine