A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
Primary Purpose
COVID-19, SARS-CoV-2 Infection
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCTV01C
SCTV01E
Sinopharm inactivated COVID-19 vaccine
Comirnaty
SCTV01E
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 ≥12 years old when signing ICF;
- Participants who were fully vaccinated with inactivated COVID-19 vaccine (Sinopharm inactivated COVID-19 vaccine), and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months;
- The participant and/or his legal guardian and/or his entrusted person 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 legal guardian and/or his entrusted person 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 1st study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.
Exclusion Criteria:
- Previously diagnosed with COVID-19;
- Presence of fever within 3 days before the study vaccination;
- A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other disease corresponding use of immunosuppressants;
- 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 first 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 (except for skin basal cell carcinoma and carcinoma in-situ of cervix), 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 received other drugs or vaccines used to prevent COVID-19 (exception for Sinopharm inactivated COVID-19 vaccine) ;
- 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 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
SCTV01C
SCTV01E
Sinopharm inactivated COVID-19 vaccine
Comirnaty
Arm Description
Participants will receive one dose of SCTV01C on Day 0 and one dose of SCTV01E on Day 180.
Participants will receive one dose of SCTV01E on Day 0 and one dose of SCTV01E on Day 180.
Participants will receive one dose of Sinopharm inactivated COVID-19 vaccine on Day 0 and one dose of SCTV01E on Day 180.
Participants will receive one dose of Comirnaty on Day 0 and one dose of SCTV01E on Day 180.
Outcomes
Primary Outcome Measures
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 28.
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 28.
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 208.
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 208.
Secondary Outcome Measures
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 and Day 208.
Seroresponse rates of neutralizing antibodiesto Delta variant on Day 28.
Seroresponse rates of neutralizing antibodies to Omicron variant rates on Day 28.
Seroresponse rates of neutralizing antibodies to Delta variant on Day 208.
Seroresponse rates of neutralizing antibodies to Omicron variant on Day 208.
Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7 and Day 180 to Day 187.
Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28 and Day 180 to Day 208.
Incidence and severity of SAEs and AESIs of SCTV01C within 365 days.
Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7 and Day 180 to Day 187.
Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28 and Day 180 to Day 208.
Incidence and severity of SAEs and AESIs of SCTV01E within 365 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05239806
Brief Title
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
Official Title
A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (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 study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.
Detailed Description
The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations (1-dose of SCTV01C and 1-dose of SCTV01E, or 2-dose of SCTV01E, or 1-dose of Sinopharm inactivated COVID-19 vaccine and 1-dose of SCTV01E, 1-dose of Comirnaty and 1-dose of SCTV01E).
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTV01C
Arm Type
Experimental
Arm Description
Participants will receive one dose of SCTV01C on Day 0 and one dose of SCTV01E on Day 180.
Arm Title
SCTV01E
Arm Type
Experimental
Arm Description
Participants will receive one dose of SCTV01E on Day 0 and one dose of SCTV01E on Day 180.
Arm Title
Sinopharm inactivated COVID-19 vaccine
Arm Type
Active Comparator
Arm Description
Participants will receive one dose of Sinopharm inactivated COVID-19 vaccine on Day 0 and one dose of SCTV01E on Day 180.
Arm Title
Comirnaty
Arm Type
Active Comparator
Arm Description
Participants will receive one dose of Comirnaty on Day 0 and one dose of SCTV01E on Day 180.
Intervention Type
Biological
Intervention Name(s)
SCTV01C
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Sinopharm inactivated COVID-19 vaccine
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Comirnaty
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
Day 180; intramuscular injection
Primary Outcome Measure Information:
Title
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 28.
Time Frame
Day 28 after the study vaccination
Title
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 28.
Time Frame
Day 28 after the study vaccination
Title
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 208.
Time Frame
Day 208 after the study vaccination
Title
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 208.
Time Frame
Day 208 after the study vaccination
Secondary Outcome Measure Information:
Title
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 and Day 208.
Time Frame
Day 28 and D208 after the study vaccination
Title
Seroresponse rates of neutralizing antibodiesto Delta variant on Day 28.
Time Frame
Day 28 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies to Omicron variant rates on Day 28.
Time Frame
Day 28 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies to Delta variant on Day 208.
Time Frame
Day 208 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies to Omicron variant on Day 208.
Time Frame
Day 208 after the study vaccination
Title
Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7 and Day 180 to Day 187.
Time Frame
Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination
Title
Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28 and Day 180 to Day 208.
Time Frame
Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination
Title
Incidence and severity of SAEs and AESIs of SCTV01C within 365 days.
Time Frame
Day 0 to Day 365 after the 1st study vaccination
Title
Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7 and Day 180 to Day 187.
Time Frame
Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination
Title
Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28 and Day 180 to Day 208.
Time Frame
Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination
Title
Incidence and severity of SAEs and AESIs of SCTV01E within 365 days.
Time Frame
Day 0 to Day 365 after the 1st study vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged ≥12 years old when signing ICF;
Participants who were fully vaccinated with inactivated COVID-19 vaccine (Sinopharm inactivated COVID-19 vaccine), and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months;
The participant and/or his legal guardian and/or his entrusted person 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 legal guardian and/or his entrusted person 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 1st study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.
Exclusion Criteria:
Previously diagnosed with COVID-19;
Presence of fever within 3 days before the study vaccination;
A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other disease corresponding use of immunosuppressants;
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 first 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 (except for skin basal cell carcinoma and carcinoma in-situ of cervix), 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 received other drugs or vaccines used to prevent COVID-19 (exception for Sinopharm inactivated COVID-19 vaccine) ;
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
Min Ke
Phone
+86 18501160269
Email
min_ke@sinocelltech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongpan Fu
Phone
+86 18612320378
Email
yongpan_fu@sinocelltech.com
12. IPD Sharing Statement
Learn more about this trial
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
We'll reach out to this number within 24 hrs