COVID-19Phase 2NCT05933512
A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines
A Phase 2 study testing SCTV01E-2 and SCTV01E in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..
Trial summary
This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- SCTV01E-2 and SCTV01E
- Type of treatment
- 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
- 10 Aug 2023to 10 Nov 2024
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Aged ≥3 years old when signing ICF;
- 2. Participants who were vaccinated with licenced COVID-19 vaccines with recommended doses and immune schedule, and the interval between the last dose and ICF is ≥6 months.
- 3. The participant and/or his/her legal guardians or entrusted person can sign the 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;
- 4. The participant and/or his/her legal guardians or entrusted person have the ability to read, understand, and fill in record cards;
- 5. Healthy participants or participants with pre-existing medical conditions who are in stable condition. 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;
- 6. 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
- 1. Presence of fever within 72 hours before the study vaccination (for participants >14 years old, axillary temperature ≥37.3℃; for participants ≤14 years old, axillary temperature ≥37.5℃;);
- 2. A positive result of antigen test or nucleic acid test for SARS-CoV-2 during the screening period;
- 3. A positive result of SARS-CoV-2 IgM test;
- 4. Known history of SARS-CoV-2 infection within 6 months before ICF;
- 5. A history of sereve allergic reactions such as severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema, or allergic reactions to the study vaccines and its ingredient;
- 6. A medical or family history of seizure, epilepsy and psychosis;
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- 7. 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;
- 8. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
- 9. Patients on antituberculosis therapy;
- 10. Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
- 11. Participants who received other investigational drugs within 1 month before the study vaccination;
- 12. Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
- 13. 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;
- 14. Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
- 15. Those who plan to donate ovum or sperms during the study period;
- 16. Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
- 17. 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2 (COVID-19 Beta/Omicron (BA.1/BQ.1.1/XBB.1) Variants S-Trimer Vaccine) in Population Previously Vaccinated With mRNA COVID-19 Vaccine
This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
Read the detailed description
For participants in Group A, they will be randomized to receive SCTV01E or SCTV01E-2 in a ratio of 1:1. For participants in Group B, they will all receive SCTV01E-2.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- SCTV01E-2, SCTV01E
- Keywords
- SARS-CoV-2, COVID-19, 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.
SCTV01E-2Biological
intramuscular injection
SCTV01EBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A:SCTV01E-2 | Experimental | one dose of SCTV01E-2 on D0 Receives: Biological: SCTV01E-2 |
| Group A:SCTV01E | Active comparator | one dose of SCTV01E on D0 Receives: Biological: SCTV01E |
| Group B:SCTV01E-2 | Experimental | one dose of SCTV01E-2 on D0 Receives: Biological: SCTV01E-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Measured: day 14 after the study vaccination
Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Measured: day 14 after the study vaccination
Secondary outcomes (6)
GMT of neutralizing antibodies against other SARS-CoV-2 variants on D14.
Measured: Day 14 after the study vaccination
SRR of neutralizing antibodies against other SARS-CoV-2 variants on D14.
Measured: Day 14 after the study vaccination
GMT and SRR of neutralizing antibodies against SARS-CoV-2 variants on D180.
Measured: day 14 after the study vaccination
Incidence and severity of solicited Adverse Events (AEs) of SCTV01E from D0 to D7.
Measured: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28.
Measured: Day 0 to Day 28 after the study vaccination
Incidence and severity of Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) of SCTV01E within 365 days.
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 posted6 Jul 2023
- Study start10 Aug 2023 (estimated)
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Nov 2024 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT05933512
- Sponsor's protocol ID
- SCTV01E-2-CHN-1
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 6 Jul 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2 (COVID-19 Beta/Omicron (BA.1/BQ.1.1/XBB.1) Variants S-Trimer Vaccine) in Population Previously Vaccinated With mRNA COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05933512
- Acronym / sponsor ID
- SCTV01E-2-CHN-1
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, COVID-19, 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
- 10 Aug 2023 (estimated)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 6 Jul 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.
This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
Detailed description
For participants in Group A, they will be randomized to receive SCTV01E or SCTV01E-2 in a ratio of 1:1. For participants in Group B, they will all receive SCTV01E-2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A:SCTV01E-2 | Experimental | Biological: SCTV01E-2one dose of SCTV01E-2 on D0 |
| Group A:SCTV01E | Active comparator | Biological: SCTV01Eone dose of SCTV01E on D0 |
| Group B:SCTV01E-2 | Experimental | Biological: SCTV01E-2one dose of SCTV01E-2 on D0 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Aged ≥3 years old when signing ICF;
- 2. Participants who were vaccinated with licenced COVID-19 vaccines with recommended doses and immune schedule, and the interval between the last dose and ICF is ≥6 months.
- 3. The participant and/or his/her legal guardians or entrusted person can sign the 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;
- 4. The participant and/or his/her legal guardians or entrusted person have the ability to read, understand, and fill in record cards;
- 5. Healthy participants or participants with pre-existing medical conditions who are in stable condition. 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 (17 listed)
- 1. Presence of fever within 72 hours before the study vaccination (for participants >14 years old, axillary temperature ≥37.3℃; for participants ≤14 years old, axillary temperature ≥37.5℃;);
- 2. A positive result of antigen test or nucleic acid test for SARS-CoV-2 during the screening period;
- 3. A positive result of SARS-CoV-2 IgM test;
- 4. Known history of SARS-CoV-2 infection within 6 months before ICF;
- 5. A history of sereve allergic reactions such as severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema, or allergic reactions to the study vaccines and its ingredient;
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 |
|---|---|---|
| SCTV01E-2intramuscular injection | Biological | Group A:SCTV01E-2, Group B:SCTV01E-2 |
| SCTV01Eintramuscular injection | Biological | Group A:SCTV01E |
Primary outcome
Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Time frame: day 14 after the study vaccination
Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Time frame: day 14 after the study vaccination
6 secondary outcomes
GMT of neutralizing antibodies against other SARS-CoV-2 variants on D14.
Time frame: Day 14 after the study vaccination
SRR of neutralizing antibodies against other SARS-CoV-2 variants on D14.
Time frame: Day 14 after the study vaccination
GMT and SRR of neutralizing antibodies against SARS-CoV-2 variants on D180.
Time frame: day 14 after the study vaccination
Incidence and severity of solicited Adverse Events (AEs) of SCTV01E from D0 to D7.
Time frame: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28.
Time frame: Day 0 to Day 28 after the study vaccination
Incidence and severity of Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) of SCTV01E within 365 days.
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 6 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCTV01E-2 and SCTV01E 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 17 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 6 Jul 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 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 Xuxin Tian (+86 10 58628288, xuxin_tian@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14. (time frame: day 14 after the study vaccination). The study lists 2 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 6 Jul 2023.