A Phase II Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine
Primary Purpose
COVID-19, SARS-CoV2 Infection
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCTV01C
Comirnaty
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 (2 doses) with inactivated COVID-19 vaccine (Sinopharm 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 subject 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 age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing age 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 corresponding 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, 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 used for prevention of COVID-19 (exception for Sinopharm 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 Type
Experimental
Active Comparator
Arm Label
SCTV01C
Comirnaty
Arm Description
Outcomes
Primary Outcome Measures
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Secondary Outcome Measures
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on D28.
Seroresponse of neutralizing antibodies of Delta (B.1.617.2) variant rates on D28.
Seroresponse of neutralizing antibodies of Omicron (B.1.1.529) rates on D28.
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D90 and D180.
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D90 and D180.
Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
GMT of neutralizing antibodies against SARS-CoV-2 variants other than Delta and Omicron variants on D28.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05239975
Brief Title
A Phase II Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously 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) in Population Aged ≥12 Years and Previously 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
February 25, 2022 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (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 immunogenicity and safety of SCTV01C in participants aged ≥12 years and previously fully immunized with inactivated COVID-19 vaccine.
Detailed Description
This is a randomized, double-blind, approved vaccine-controlled Phase II booster study to evaluate the immunogenicity and safety of SCTV01C compared with Comirnaty in participants aged ≥12 years and previously fully immunized with inactivated COVID-19 vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV2 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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTV01C
Arm Type
Experimental
Arm Title
Comirnaty
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
SCTV01C
Intervention Description
intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Comirnaty
Intervention Description
intramuscular injection
Primary Outcome Measure Information:
Title
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time Frame
Day 28 after the study vaccination
Secondary Outcome Measure Information:
Title
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on D28.
Time Frame
Day 28 after the study vaccination
Title
Seroresponse of neutralizing antibodies of Delta (B.1.617.2) variant rates on D28.
Time Frame
Day 28 after the study vaccination
Title
Seroresponse of neutralizing antibodies of Omicron (B.1.1.529) rates on D28.
Time Frame
Day 28 after the study vaccination
Title
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Time Frame
Day 28 after the study vaccination
Title
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D90 and D180.
Time Frame
Day 90 and Day 180 after the study vaccination
Title
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D90 and D180.
Time Frame
Day 90 and Day 180 after the study vaccination
Title
Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time Frame
Day 0 to Day 7 after the study vaccination
Title
Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time Frame
Day 0 to Day 28 after the study vaccination
Title
Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time Frame
Day 0 to Day 180 after the study vaccination
Title
GMT of neutralizing antibodies against SARS-CoV-2 variants other than Delta and Omicron variants on D28.
Time Frame
Day 28 after the 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 (2 doses) with inactivated COVID-19 vaccine (Sinopharm 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 subject 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 age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing age 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 corresponding 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, 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 used for prevention of COVID-19 (exception for Sinopharm 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
Zhen Yao
Phone
+86 13683086445
Email
zhen_yao@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 Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine
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