COVID-19Phase 2NCT05239975
A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine
A Phase 2 study testing SCTV01C and Comirnaty in people with COVID-19 and SARS-CoV2 Infection, run by Sinocelltech Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV2 Infection
- What is being tested?
- SCTV01C and Comirnaty
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2022to 1 Feb 2023
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, SARS-CoV2 Infection
- Being tested
- SCTV01C, 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
ComirnatyBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| SCTV01C | Experimental | Participants will be administrated one dose of SCTV01C on Day 0 and Day 180 Receives: Biological: SCTV01C |
| Comirnaty | Active comparator | Participants will be administrated one dose of Comirnaty on Day 0 and Day 180 Receives: Biological: Comirnaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Measured: Day 28 after the study vaccination
Secondary outcomes (10)
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on D28.
Measured: Day 28 after the study vaccination
Seroresponse rates of neutralizing antibodies of Delta (B.1.617.2) variant on D28.
Measured: Day 28 after the study vaccination
Seroresponse rates of neutralizing antibodies of Omicron (B.1.1.529) on D28.
Measured: Day 28 after the study vaccination
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Measured: Day 28 after the study vaccination
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D90 and D180.
Measured: Day 90 and Day 180 after the study vaccination
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D90 and D180.
Measured: Day 90 and Day 180 after the study vaccination
Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Measured: Day 0 to Day 7 after the study vaccination
Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Measured: Day 0 to Day 28 after the study vaccination
Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Measured: Day 0 to Day 180 after the study vaccination
GMT of neutralizing antibodies against SARS-CoV-2 variants other than Delta and Omicron variants on D28.
Measured: Day 28 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 posted15 Feb 2022
- Study start25 Apr 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Why it stopped: There was not a need to carry out a study in LAO any more.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239975
- Sponsor's protocol ID
- SCTV01C-01-In-LAO-1
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 9 Feb 2024
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05239975
- Acronym / sponsor ID
- SCTV01C-01-In-LAO-1
- Conditions
- COVID-19, SARS-CoV2 Infection
- Keywords
- COVID-19, SARS-CoV-2 infection, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There was not a need to carry out a study in LAO any more.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 15 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 ≥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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTV01C | Experimental | Biological: SCTV01CParticipants will be administrated one dose of SCTV01C on Day 0 and Day 180 |
| Comirnaty | Active comparator | Biological: ComirnatyParticipants will be administrated one dose of Comirnaty on Day 0 and Day 180 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
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 | SCTV01C |
| Comirnatyintramuscular injection | Biological | Comirnaty |
Primary outcome
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
10 secondary outcomes
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
Seroresponse rates of neutralizing antibodies of Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Seroresponse rates of neutralizing antibodies of Omicron (B.1.1.529) on D28.
Time frame: Day 28 after the study vaccination
GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Time frame: Day 28 after the study vaccination
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
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
Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 0 to Day 180 after the study vaccination
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCTV01C and Comirnaty in people with COVID-19 and SARS-CoV2 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 21 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: withdrawn, as of the sponsor's last update on 9 Feb 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28. (time frame: Day 28 after the study vaccination). 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 9 Feb 2024.