A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine
Primary Purpose
COVID-19, Sars-CoV-2 Infection
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCTV01E
Comirnaty
SCTV01E
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 ≥18 years old when signing ICF;
- Participants who were fully vaccinated with 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna) and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months.
- The participant can sign the written ICF (by applying his / her signature or fingerprint "for illiterate subject"), 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 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;
- A positive result of nucleic acid test for SARS-CoV-2 during the screening period;
- 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 (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 received other drugs or vaccines used to prevent COVID-19, but participants previously received Comirnaty from Pfizer or mRNA-1273 from Moderna will not be excluded;
- 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 Type
Experimental
Active Comparator
Active Comparator
Arm Label
SCTV01E and SCTV01E
Comirnaty and SCTV01E
Comirnaty and Comirnaty
Arm Description
SCTV01E on D0 and D180
Comirnaty on D0 and SCTV01E on D180
Comirnaty on D0 and D180
Outcomes
Primary Outcome Measures
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on D28.
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on D208.
Secondary Outcome Measures
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on D28.
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on D208.
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28 and D208.
Seroresponse rates of neutralizing antibodies of Delta variant from on D28.
Seroresponse rates of neutralizing antibodies of Omicron variant from on D28.
Seroresponse rates of neutralizing antibodies of Delta variant from on D208.
Seroresponse rates of neutralizing antibodies of Omicron variant from on D208.
Incidence and severity of solicited AEs of SCTV01E from D0 to D7 and D180 to D187.
Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28 and D180 to D208.
Incidence and severity of SAEs and AESIs of SCTV01E within 365 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05238441
Brief Title
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine
Official Title
A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 20, 2022 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
May 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 this study is to evaluate the immunogenicity and safety of SCTV01E in participants aged ≥18 years and previously fully immunized with mRNA COVID-19 vaccine.
Detailed Description
The study is a randomized, double-blind, and positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E as booster compared with Comirnaty. The study is a randomized, double-blind, and positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E as booster compared with Comirnaty (the COVID-19 vaccine from Pfizer-BioNTech).
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
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTV01E and SCTV01E
Arm Type
Experimental
Arm Description
SCTV01E on D0 and D180
Arm Title
Comirnaty and SCTV01E
Arm Type
Active Comparator
Arm Description
Comirnaty on D0 and SCTV01E on D180
Arm Title
Comirnaty and Comirnaty
Arm Type
Active Comparator
Arm Description
Comirnaty on D0 and D180
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
D0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Comirnaty
Intervention Description
D0; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCTV01E
Intervention Description
D180; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Comirnaty
Intervention Description
D180; intramuscular injection
Primary Outcome Measure Information:
Title
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on D28.
Time Frame
Day 28 after the study vaccination
Title
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on D208.
Time Frame
Day 208 after the study vaccination
Secondary Outcome Measure Information:
Title
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on D28.
Time Frame
Day 28 after the study vaccination
Title
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on D208.
Time Frame
Day 208 after the study vaccination
Title
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28 and D208.
Time Frame
Day 28 and Day 208 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies of Delta variant from on D28.
Time Frame
Day 28 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies of Omicron variant from on D28.
Time Frame
Day 28 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies of Delta variant from on D208.
Time Frame
Day 208 after the study vaccination
Title
Seroresponse rates of neutralizing antibodies of Omicron variant from on D208.
Time Frame
Day 208 after the study vaccination
Title
Incidence and severity of solicited AEs of SCTV01E from D0 to D7 and D180 to D187.
Time Frame
Day 0 to Day 7 and Day 180 to Day 187 after the study vaccination
Title
Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28 and D180 to D208.
Time Frame
Day 0 to Day 287 and Day 180 to Day 208 after the study vaccination
Title
Incidence and severity of SAEs and AESIs of SCTV01E within 365 days.
Time Frame
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 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna) and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months.
The participant can sign the written ICF (by applying his / her signature or fingerprint "for illiterate subject"), 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 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;
A positive result of nucleic acid test for SARS-CoV-2 during the screening period;
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 (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 received other drugs or vaccines used to prevent COVID-19, but participants previously received Comirnaty from Pfizer or mRNA-1273 from Moderna will not be excluded;
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
Zibin Luo
Phone
+86 13751891764
Email
zibin_luo@sinocelltech.com
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 Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine
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