COVID-19 SARS-CoV-2 InfectionPhase 3NCT05683561
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E in Healthy People
A Phase 3 study testing CoronaVac and SCTV01E in people with COVID-19 SARS-CoV-2 Infection, run by Sinocelltech Ltd..
Trial summary
The objective of this study is to evaluate the effectiveness of SCTV01E in healthy people 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?
- CoronaVac and SCTV01E
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2023to 25 Aug 2024
- Phase
- Phase 3
- 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 (the specific age range depends on the authorized age range by local regulatory authority);
- Participants who were vaccinated with primary series COVID-19 vaccine and/or received booster vaccination, and the last dose of COVID-19 vaccine was received more than 3 months;
- The participant and/or his/her 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 baseline SARS-CoV-2 anti-Spike IgG will be measured at the screening period and an upper IgG limit may be used to screen the participants. It is aimed to recruit participants who are susceptible to SARS-CoV-2 infection. The participant with the IgG level higher than the limit may be excluded from the study. The IgG limit will be determined based on the average level of IgG in a region, and may not be applied if the incidence rate of COVID-19 is low;
- The participant and/or his/her 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 potential 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 potential are negative on screening.
Who cannot join
- A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period;
- Known history of SARS-CoV-2 infection in past 6 months before the study vaccination;
- Presence of fever within 3 days before the study vaccination;
- A history of severe allergic reactions to any vaccines or drugs, such as 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 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 30 days before the study vaccination or who intend to participate in another clinical study at any time during the conduct of this study;
- Participants who have acute illness, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis;
- 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 III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Healthy People
The objective of this study is to evaluate the effectiveness of SCTV01E in healthy people
Read the detailed description
The study is a randomized, double-blind, placebo-controlled Phase III study. It will evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in participants who were previously received primary series or booster dose of COVID-19 vaccines.
- Conditions
- COVID-19 SARS-CoV-2 Infection
- Being tested
- CoronaVac, SCTV01E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronaVacBiological
D0; intramuscular injection
SCTV01EBiological
D0; intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| CoronaVac | Active comparator | one dose of CoronaVac on D0 Receives: Biological: CoronaVac |
| SCTV01E | Experimental | one dose of SCTV01E on D0 Receives: Biological: SCTV01E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 14 days (≥15 days) after the study vaccination
To evalute the efficacy of SCTV01E
Measured: From Day 15 to Day 365
Secondary outcomes (9)
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 7 days (≥8 days) after the study vaccination.
To evalute the efficacy of SCTV01E
Measured: From Day 8 to Day 365
Cases of the first occurrence of moderate and above COVID-19, severe and above COVID-19, hospitalization due to COVID-19, and death due to COVID-19, respectively, starting 7 days (≥8 days) after the study vaccination
To evalute the efficacy of SCTV01E
Measured: From Day 8 to Day 365
Cases of the first occurrence of moderate and above COVID-19, severe and above COVID-19, hospitalization due to COVID-19, and death due to COVID-19, respectively, starting 14 days (≥15 days) after the study vaccination.
To evalute the efficacy of SCTV01E
Measured: From Day 15 to Day 365
Cases of the first occurrence of symptomatic COVID-19 of any severity caused by SARS-CoV-2 variants and subvariants starting 7 days (≥8 days) after the study vaccination.
To evalute the efficacy of SCTV01E
Measured: From Day 8 to Day 365
Cases of the first occurrence of symptomatic COVID-19 of any severity caused by SARS-CoV-2 variants and subvariants starting 14 days (≥15 days) after the study vaccination.
To evalute the efficacy of SCTV01E
Measured: From Day 15 to Day 365
Geometric mean titers (GMT) of neutralizing antibodies (nAb) against SARS-CoV-2 (including its variants and subvariants) on D28.
To evalute the immunogenicity of SCTV01E
Measured: From Day 0 to Day 28
Incidence and severity of solicited AEs of SCTV01E from D0 to D7
To evalute the safety of SCTV01E
Measured: From Day 0 to Day 7
Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.
To evalute the safety of SCTV01E
Measured: From Day 0 to Day 28
Incidence and severity of SAEs and AESIs.
To evalute the safety of SCTV01E
Measured: From Day 0 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start25 Jan 2023 (estimated)
- Primary completion25 Aug 2023 (estimated)
- Study completion25 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 SARS-CoV-2 InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Sun, Study chair, Sinocelltech Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683561
- Sponsor's protocol ID
- SCTV01E-MRCT-1
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 13 Jan 2023
- 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 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Positive-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Healthy People
- ClinicalTrials.gov ID
- NCT05683561
- Acronym / sponsor ID
- SCTV01E-MRCT-1
- Conditions
- COVID-19 SARS-CoV-2 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 13 Jan 2023 (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 effectiveness of SCTV01E in healthy people
Detailed description
The study is a randomized, double-blind, placebo-controlled Phase III study. It will evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in participants who were previously received primary series or booster dose of COVID-19 vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoronaVac | Active comparator | Biological: CoronaVacone dose of CoronaVac on D0 |
| SCTV01E | Experimental | Biological: SCTV01Eone dose of SCTV01E on D0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥18 years old when signing ICF (the specific age range depends on the authorized age range by local regulatory authority);
- Participants who were vaccinated with primary series COVID-19 vaccine and/or received booster vaccination, and the last dose of COVID-19 vaccine was received more than 3 months;
- The participant and/or his/her 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 baseline SARS-CoV-2 anti-Spike IgG will be measured at the screening period and an upper IgG limit may be used to screen the participants. It is aimed to recruit participants who are susceptible to SARS-CoV-2 infection. The participant with the IgG level higher than the limit may be excluded from the study. The IgG limit will be determined based on the average level of IgG in a region, and may not be applied if the incidence rate of COVID-19 is low;
- The participant and/or his/her legal guardian and/or his entrusted person have the ability to read, understand, and fill in record cards;
Key exclusion criteria (20 listed)
- A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period;
- Known history of SARS-CoV-2 infection in past 6 months before the study vaccination;
- Presence of fever within 3 days before the study vaccination;
- A history of severe allergic reactions to any vaccines or drugs, such as 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 |
|---|---|---|
| CoronaVacD0; intramuscular injection | Biological | CoronaVac |
| SCTV01ED0; intramuscular injection | Biological | SCTV01E |
Primary outcome
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 14 days (≥15 days) after the study vaccination
Time frame: From Day 15 to Day 365
To evalute the efficacy of SCTV01E
9 secondary outcomes
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 7 days (≥8 days) after the study vaccination.
Time frame: From Day 8 to Day 365
Cases of the first occurrence of moderate and above COVID-19, severe and above COVID-19, hospitalization due to COVID-19, and death due to COVID-19, respectively, starting 7 days (≥8 days) after the study vaccination
Time frame: From Day 8 to Day 365
Cases of the first occurrence of moderate and above COVID-19, severe and above COVID-19, hospitalization due to COVID-19, and death due to COVID-19, respectively, starting 14 days (≥15 days) after the study vaccination.
Time frame: From Day 15 to Day 365
Cases of the first occurrence of symptomatic COVID-19 of any severity caused by SARS-CoV-2 variants and subvariants starting 7 days (≥8 days) after the study vaccination.
Time frame: From Day 8 to Day 365
Cases of the first occurrence of symptomatic COVID-19 of any severity caused by SARS-CoV-2 variants and subvariants starting 14 days (≥15 days) after the study vaccination.
Time frame: From Day 15 to Day 365
Geometric mean titers (GMT) of neutralizing antibodies (nAb) against SARS-CoV-2 (including its variants and subvariants) on D28.
Time frame: From Day 0 to Day 28
Incidence and severity of solicited AEs of SCTV01E from D0 to D7
Time frame: From Day 0 to Day 7
Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.
Time frame: From Day 0 to Day 28
Incidence and severity of SAEs and AESIs.
Time frame: From Day 0 to Day 365
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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.
Yu Sun study chair
Sinocelltech Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CoronaVac and SCTV01E in people with COVID-19 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 7 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 13 Jan 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yu Sun (+86 13816901291, yu_sun@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 14 days (≥15 days) after the study vaccination (time frame: From Day 15 to Day 365). 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 13 Jan 2023.