A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years
Primary Purpose
COVID-19, SARS-CoV-2 Infection
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCTV01C
SCTV01C
SCTV01C
SCTV01E
SCTV01E
SCTV01E
mRNA vaccine manufactured by Pfizer or Moderna
mRNA vaccine manufactured by Pfizer or Moderna
mRNA vaccine manufactured by Pfizer or Moderna
Sinopharm inactivated COVID-19 vaccine
Sinopharm inactivated COVID-19 vaccine
Sinopharm inactivated COVID-19 vaccine
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 neither vaccinated with any COVID-19 vaccine (including COVID-19 vaccine or vaccine adjuvant in clinical trial) nor diagnosed with COVID-19;
- Participants or his/her legal guardian (or entrusted person) can sign written ICF and voluntarily participate in the trial, 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;
- Participant him/herself or with the assistance of his/her family member is capable of finishing the 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 last dose of study vaccination; the pregnancy test results of women of childbearing age are negative on screening.
Exclusion Criteria:
- Presence of fever within 3 days before the study vaccination;
- A positive result of IgG antibody against the SARS-CoV-2 virus during the screen period;
- 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 1st 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 (exception 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;
- 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
mRNA vaccine manufactured by Pfizer or Moderna
Sinopharm inactivated COVID-19 vaccine
Arm Description
Outcomes
Primary Outcome Measures
Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination);
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 56 (28 days after the 2nd dose of vaccination);
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 56 (28 days after the 2nd dose of vaccination);
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 208 (28 days after the 3rd dose of vaccination);
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 208 (28 days after the 3rd dose of vaccination);
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 208 (28 days after the 3rd dose of vaccination);
Incidence and severity of solicited AEs within 7 days after each dose of vaccine (Day 0 to Day 7, Day 28 to Day 35, and Day 180 to Day 187).
Secondary Outcome Measures
Stage 1: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Stage 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 0, Day14, Day 28 and Day 42;
Stage 1: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 56;
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 365 (185 days after the 3rd dose of vaccination);
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 365 (185 days after the 3rd dose of vaccination);
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 365 (185 days after the 3rd dose of vaccination);
Stage 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination);
Stage 2: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 208;
Incidence and severity of unsolicited systemic AEs within 28 days after each dose of vaccine (Day 0 to Day 28, Day 28 to Day 56, and Day 180 to Day 208);
Incidence and severity of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 365 days after the 1st dose of vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05308602
Brief Title
A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years
Official Title
A Randomized, Double-blinded, Active-controlled Phase II Clinical Study 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 and Previously Unvaccinated
Study Type
Interventional
2. Study Status
Record Verification Date
March 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 the study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine.
Detailed Description
The study is a randomized, double-blinded, active-controlled (Approved vaccine) Phase II clinical study. The study consists of 2 stages, Stage 1 and 2. In Stage 1, participants would randomly receive 2 doses of SCTV01C, SCTV01E, Sinopharm COVID-19 vaccine or mRNA vaccine on Day 0 and Day 28. Stage 1 is aimed to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants after the 2nd dose of vaccination with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine. Stage 2 will start on Day 180 and the participants will receive a 3rd dose of vaccination.
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
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTV01C
Arm Type
Experimental
Arm Title
SCTV01E
Arm Type
Experimental
Arm Title
mRNA vaccine manufactured by Pfizer or Moderna
Arm Type
Active Comparator
Arm Title
Sinopharm inactivated COVID-19 vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
SCTV01C
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01C
Intervention Description
Day 28; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01C
Intervention Description
Day 180; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
Day 28; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
Day 180; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
mRNA vaccine manufactured by Pfizer or Moderna
Intervention Description
Day 0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
mRNA vaccine manufactured by Pfizer or Moderna
Intervention Description
Day 28; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
mRNA vaccine manufactured by Pfizer or Moderna
Intervention Description
Day 180; 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)
Sinopharm inactivated COVID-19 vaccine
Intervention Description
Day 28; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Sinopharm inactivated COVID-19 vaccine
Intervention Description
Day 180; intramuscular injection
Primary Outcome Measure Information:
Title
Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time Frame
Day 56 after the study vaccination
Title
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time Frame
Day 56 after the study vaccination
Title
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time Frame
Day 56 after the study vaccination
Title
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time Frame
Day 208 after the study vaccination
Title
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time Frame
Day 208 after the study vaccination
Title
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time Frame
Day 208 after the study vaccination
Title
Incidence and severity of solicited AEs within 7 days after each dose of vaccine (Day 0 to Day 7, Day 28 to Day 35, and Day 180 to Day 187).
Time Frame
7 days after each study vaccination
Secondary Outcome Measure Information:
Title
Stage 1: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time Frame
Day 180 after the study vaccination
Title
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time Frame
Day 180 after the study vaccination
Title
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time Frame
Day 180 after the study vaccination
Title
Stage 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 0, Day14, Day 28 and Day 42;
Time Frame
Day 0, Day 14, Day 28 and Day 42 after the study vaccination
Title
Stage 1: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 56;
Time Frame
Day 56 after the study vaccination
Title
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time Frame
Day 365 after the study vaccination
Title
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time Frame
Day 365 after the study vaccination
Title
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time Frame
Day 365 after the study vaccination
Title
Stage 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination);
Time Frame
Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination)
Title
Stage 2: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 208;
Time Frame
Day 208 after the study vaccination
Title
Incidence and severity of unsolicited systemic AEs within 28 days after each dose of vaccine (Day 0 to Day 28, Day 28 to Day 56, and Day 180 to Day 208);
Time Frame
28 days after each study vaccination
Title
Incidence and severity of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 365 days after the 1st dose of vaccination.
Time Frame
Day 0 to Day 365 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 neither vaccinated with any COVID-19 vaccine (including COVID-19 vaccine or vaccine adjuvant in clinical trial) nor diagnosed with COVID-19;
Participants or his/her legal guardian (or entrusted person) can sign written ICF and voluntarily participate in the trial, 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;
Participant him/herself or with the assistance of his/her family member is capable of finishing the 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 last dose of study vaccination; the pregnancy test results of women of childbearing age are negative on screening.
Exclusion Criteria:
Presence of fever within 3 days before the study vaccination;
A positive result of IgG antibody against the SARS-CoV-2 virus during the screen period;
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 1st 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 (exception 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;
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
Lili Ma
Phone
+86 15116994890
Email
lili_ma@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 Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years
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