COVID-19Phase 2NCT05238454
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C in Population Aged ≥18 Years and Previously Fully Vaccinated With COVID-19 Vaccine
A Phase 2 study testing SCTV01C, Sinopharm inactivated COVID-19 vaccine and Comirnaty in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..
Trial summary
The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- SCTV01C, Sinopharm inactivated COVID-19 vaccine and Comirnaty
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2022to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years old when signing ICF;
- For Cohort 1: Participants who were fully vaccinated with 2 doses of inactivated COVID-19 vaccine (Sinopharm inactivated COVID-19 vaccine) or previously diagnosed with COVID-19. The interval between the last dose and this study vaccination is ≥3 months and ≤12 months. The interval between the last day diagnosed with COVID-19 and this study vaccination is ≥3 months and ≤12 months; For Cohort 2: Participants who were fully vaccinated with 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna) or previously diagnosed with COVID-19. The interval between the last dose and this study vaccination is ≥3 months and ≤12 months. The interval between the last day diagnosed with COVID-19 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 has 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 study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.
Who cannot join
- 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 with 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;
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- 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 Sinopharm inactivated COVID-19 vaccine, Comirnaty or mRNA-1273 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥18 Years Previously Fully Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19
The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
Read the detailed description
The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01C compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- SCTV01C, Sinopharm inactivated COVID-19 vaccine, Comirnaty
- Keywords
- COVID-19, SARS-CoV-2 infection, Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTV01CBiological
intramuscular injection
Sinopharm inactivated COVID-19 vaccineBiological
intramuscular injection
ComirnatyBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: SCTV01C | Experimental | Not described Receives: Biological: SCTV01C |
| Cohort 1: Sinopharm inactivated COVID-19 vaccine | Active comparator | Not described Receives: Biological: Sinopharm inactivated COVID-19 vaccine |
| Cohort 2: SCTV01C | Experimental | Not described Receives: Biological: SCTV01C |
| Cohort 2: Comirnaty | Active comparator | Not described Receives: Biological: Comirnaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Measured: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28
Measured: Day 28 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Measured: Day 0 to Day 7 after the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Measured: Day 0 to Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Measured: Day 28 after the study vaccination
Cohort 2: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Measured: Day 0 to Day 7 after the study vaccination
Cohort 2: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Measured: Day 0 to Day 28 after the study vaccination
Secondary outcomes (13)
Cohort 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Measured: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Measured: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Measured: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Measured: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Measured: Day 28 after the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Measured: Day 28 after the study vaccination
Cohort 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Measured: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Measured: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Measured: Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Measured: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Measured: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Measured: Day 28 after the study vaccination
Cohort 2: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Measured: Day 0 to Day 180 after the study vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start20 Mar 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, positive-controlled Phase II clinical trial to evaluate the immunogenicity and safety of SCTV01C in population aged ≥18 years previously fully vaccinated with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19 and compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238454
- Sponsor's protocol ID
- SCTV01C-01-JOR-1
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥18 Years Previously Fully Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT05238454
- Acronym / sponsor ID
- SCTV01C-01-JOR-1
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2 infection, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
Detailed description
The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01C compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This is a randomized, double-blind, positive-controlled Phase II clinical trial to evaluate the immunogenicity and safety of SCTV01C in population aged ≥18 years previously fully vaccinated with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19 and compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: SCTV01C | Experimental | Biological: SCTV01C |
| Cohort 1: Sinopharm inactivated COVID-19 vaccine | Active comparator | Biological: Sinopharm inactivated COVID-19 vaccine |
| Cohort 2: SCTV01C | Experimental | Biological: SCTV01C |
| Cohort 2: Comirnaty | Active comparator | Biological: Comirnaty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥18 years old when signing ICF;
- For Cohort 1: Participants who were fully vaccinated with 2 doses of inactivated COVID-19 vaccine (Sinopharm inactivated COVID-19 vaccine) or previously diagnosed with COVID-19. The interval between the last dose and this study vaccination is ≥3 months and ≤12 months. The interval between the last day diagnosed with COVID-19 and this study vaccination is ≥3 months and ≤12 months; For Cohort 2: Participants who were fully vaccinated with 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna) or previously diagnosed with COVID-19. The interval between the last dose and this study vaccination is ≥3 months and ≤12 months. The interval between the last day diagnosed with COVID-19 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 has 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;
Key exclusion criteria (20 listed)
- 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 with 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTV01Cintramuscular injection | Biological | Cohort 1: SCTV01C, Cohort 2: SCTV01C |
| Sinopharm inactivated COVID-19 vaccineintramuscular injection | Biological | Cohort 1: Sinopharm inactivated COVID-19 vaccine |
| Comirnatyintramuscular injection | Biological | Cohort 2: Comirnaty |
Primary outcome
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28
Time frame: Day 28 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Cohort 2: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
13 secondary outcomes
Cohort 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 28 after the study vaccination
Cohort 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 2: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 0 to Day 180 after the study vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCTV01C, Sinopharm inactivated COVID-19 vaccine and Comirnaty in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zibin Luo (+86 13751891764, zibin_luo@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28. (time frame: Day 28 after the study vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.