A Study to Evaluate the Efficacy and Safety of SCTV01E (a Recombinant Protein COVID-19 Vaccine) in Population Aged ≥18 Years
Primary Purpose
COVID-19, SARS-CoV-2 Infection
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SCTV01E
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2 infection, Vaccine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SCTV01E
Placebo
Arm Description
one dose of SCTV01E on D0
one dose of Placebo on D0
Outcomes
Primary Outcome Measures
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 14 days (≥15 days) after the study vaccination
Secondary Outcome Measures
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.
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 28 days after the study vaccination
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.
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.
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.
Stage 1: Incidence and severity of solicited AEs of SCTV01E from D0 to D7 in Cohort 3.
Safety: Incidence and severity of solicited AEs of SCTV01E from D0 to D7.
Safety: Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.
Safety: Incidence and severity of SAEs and AESIs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05308576
Brief Title
A Study to Evaluate the Efficacy and Safety of SCTV01E (a Recombinant Protein COVID-19 Vaccine) in Population Aged ≥18 Years
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinocelltech Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2 Infection
Keywords
COVID-19, SARS-CoV-2 infection, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTV01E
Arm Type
Experimental
Arm Description
one dose of SCTV01E on D0
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one dose of Placebo on D0
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
D0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
D0; intramuscular injection
Primary Outcome Measure Information:
Title
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 14 days (≥15 days) after the study vaccination
Time Frame
From Day 15 to Day 365
Secondary Outcome Measure Information:
Title
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.
Time Frame
From Day 15 to Day 365
Title
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 28 days after the study vaccination
Time Frame
From Day 29 to Day 365
Title
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.
Time Frame
From Day 15 to Day 365
Title
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.
Time Frame
28 days after the study vaccination
Title
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.
Time Frame
28 days after the study vaccination
Title
Stage 1: Incidence and severity of solicited AEs of SCTV01E from D0 to D7 in Cohort 3.
Time Frame
Day 0 to Day 7 after the 1st study vaccination
Title
Safety: Incidence and severity of solicited AEs of SCTV01E from D0 to D7.
Time Frame
Day 0 to Day 7 after the study vaccination.
Title
Safety: Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.
Time Frame
Day 0 to Day 28 after the study vaccination.
Title
Safety: Incidence and severity of SAEs and AESIs.
Time Frame
Day 0 to Day 365 after the study vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Sun
Phone
+86 13816901291
Email
yu_sun@sinocelltech.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of SCTV01E (a Recombinant Protein COVID-19 Vaccine) in Population Aged ≥18 Years
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