COVID-19Phase 3NCT05323461
A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines
A Phase 3 study testing SCTV01C, SCTV01E and Sinopharm inactivated COVID-19 vaccine in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd. at 1 site in United Arab Emirates.
Trial summary
The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2). 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, SCTV01E and Sinopharm inactivated COVID-19 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 May 2022to 1 May 2023
- 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;
- For Subgroup 1 in Cohort 1: Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine. The interval between the date of last dose and the date of this study vaccination should be 3 to 24 months.
- For Subgroup 2 in Cohort 1: 1) Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine, with or without COVID-19 history; or 2) Participants who were previously vaccinated with 1 dose of Sinopharm inactivated COVID-19 vaccine and previously diagnosed with COVID-19. The interval between the date of last dose/COVID-19 diagnosis and the date of this study vaccination should be 3 to 24 months.
- For Cohort 2: 1) Participants who were previously vaccinated with 2 or 3 doses of mRNA COVID-19 vaccine (Comirnaty or mRNA-1273), with or without COVID-19 history; or 2) Participants who were previously vaccinated with 1 doses of mRNA COVID-19 vaccine (Comirnaty or mRNA-1273) and previously diagnosed with COVID-19; or 3) Participants who were previously not vaccinated with any COVID-19 vaccine and previously diagnosed with COVID-19. The interval between the date of last dose/COVID-19 diagnosis and the date of this study vaccination should be 3 to 24 months.
- The participant and/or his legally acceptable representative 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 participant and/or his legally acceptable representative 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 study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.
Who cannot join
- For Subgroup 1 in Cohort 1 only: 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 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.;
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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 (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
1 site in 1 country.
United Arab Emirates1 site
Al Kuwait Hospital (Al Baraha Hospital)
Dubai
About this study
Official title: A Randomized, Double-blind, and Positive-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19
The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).
Read the detailed description
Approximately 1,800 participants aged 18 years old and above will be enrolled in this study. 1,350 participants who previously received Sinopharm inactivated COVID-19 vaccine will be enrolled to Cohort 1. 450 participants who previously received mRNA COVID-19 vaccine or previously diagnosed with COVID-19 will be enrolled to Cohort 2.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- SCTV01C, SCTV01E, Sinopharm inactivated COVID-19 vaccine, Comirnaty
- Keywords
- COVID-19, SARS-CoV-2, 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
SCTV01EBiological
intramuscular injection
Sinopharm inactivated COVID-19 vaccineBiological
intramuscular injection
ComirnatyBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: SCTV01C | Experimental | one dose of SCTV01C on D0 Receives: Biological: SCTV01C |
| Cohort 1: SCTV01E | Experimental | one dose of SCTV01E on D0 Receives: Biological: SCTV01E |
| Cohort 1: Active comparator | Active comparator | one dose of Sinopharm inactivated COVID-19 vaccine on D0 Receives: Biological: Sinopharm inactivated COVID-19 vaccine |
| Cohort 2: SCTV01C | Experimental | one dose of SCTV01C on D0 Receives: Biological: SCTV01C |
| Cohort 2: SCTV01E | Experimental | one dose of SCTV01E on D0 Receives: Biological: SCTV01E |
| Cohort 2: Active comparator | Active comparator | one dose of Comirnaty on D0 Receives: Biological: Comirnaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of nAb against Delta variant on Day 28
Measured: Day 28 after the study vaccination
GMT of nAb against Omicron variant on Day 28
Measured: Day 28 after the study vaccination
Secondary outcomes (10)
GMT of nAb against Delta variant on Day 180
Measured: Day 180 after the study vaccination
GMT of nAb against Omicron variant on Day 180
Measured: Day 180 after the study vaccination
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28
Measured: Day 28 after the study vaccination
Seroresponse rates of nAb to Delta variant on Day 28.
Seroresponse is defined as a change from below the low limit of quantitation [LLOQ] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from Day0
Measured: Day 28 after the study vaccination
Seroresponse rates of nAb to Omicron variant on Day 28.
Seroresponse is defined as a change from below the low limit of quantitation [LLOQ] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from Day0
Measured: Day 28 after the study vaccination
Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7
Measured: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28
Measured: Day 0 to Day 28 after the study vaccination
Incidence and severity of SAEs and AESIs of SCTV01C within 180 days
Measured: Day 0 to Day 180 after the study vaccination
Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7
Measured: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28
Measured: Day 0 to 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 posted12 Apr 2022
- Study start30 May 2022
- Primary completion28 Oct 2022
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 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
- NCT05323461
- Sponsor's protocol ID
- SCTV01C-E-01-UAE-1
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hannawi S, Yan L, Saifeldin L, Abuquta A, Alamadi A, Mahmoud SA, Hassan A, Zhang M, Gao C, Chen Y, Gai W, Xie L. Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial. EClinicalMedicine. 2023 Sep 8;64:102195. doi: 10.1016/j.eclinm.2023.102195. eCollection 2023 Oct.
PubMed 37731938Wang R, Huang H, Yu C, Sun C, Ma J, Kong D, Lin Y, Zhao D, Zhou S, Lu J, Cao S, Zhang Y, Luo C, Li X, Wang Y, Xie L. A spike-trimer protein-based tetravalent COVID-19 vaccine elicits enhanced breadth of neutralization against SARS-CoV-2 Omicron subvariants and other variants. Sci China Life Sci. 2023 Aug;66(8):1818-1830. doi: 10.1007/s11427-022-2207-7. Epub 2022 Dec 30.
PubMed 36598621
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, and Positive-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT05323461
- Acronym / sponsor ID
- SCTV01C-E-01-UAE-1
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2, Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 12 Apr 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 study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).
Detailed description
Approximately 1,800 participants aged 18 years old and above will be enrolled in this study. 1,350 participants who previously received Sinopharm inactivated COVID-19 vaccine will be enrolled to Cohort 1. 450 participants who previously received mRNA COVID-19 vaccine or previously diagnosed with COVID-19 will be enrolled to Cohort 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: SCTV01C | Experimental | Biological: SCTV01Cone dose of SCTV01C on D0 |
| Cohort 1: SCTV01E | Experimental | Biological: SCTV01Eone dose of SCTV01E on D0 |
| Cohort 1: Active comparator | Active comparator | Biological: Sinopharm inactivated COVID-19 vaccineone dose of Sinopharm inactivated COVID-19 vaccine on D0 |
| Cohort 2: SCTV01C | Experimental | Biological: SCTV01Cone dose of SCTV01C on D0 |
| Cohort 2: SCTV01E | Experimental | Biological: SCTV01Eone dose of SCTV01E on D0 |
| Cohort 2: Active comparator | Active comparator | Biological: Comirnatyone dose of Comirnaty on D0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged ≥18 years old when signing ICF;
- For Subgroup 1 in Cohort 1: Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine. The interval between the date of last dose and the date of this study vaccination should be 3 to 24 months.
- For Subgroup 2 in Cohort 1: 1) Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine, with or without COVID-19 history; or 2) Participants who were previously vaccinated with 1 dose of Sinopharm inactivated COVID-19 vaccine and previously diagnosed with COVID-19. The interval between the date of last dose/COVID-19 diagnosis and the date of this study vaccination should be 3 to 24 months.
- For Cohort 2: 1) Participants who were previously vaccinated with 2 or 3 doses of mRNA COVID-19 vaccine (Comirnaty or mRNA-1273), with or without COVID-19 history; or 2) Participants who were previously vaccinated with 1 doses of mRNA COVID-19 vaccine (Comirnaty or mRNA-1273) and previously diagnosed with COVID-19; or 3) Participants who were previously not vaccinated with any COVID-19 vaccine and previously diagnosed with COVID-19. The interval between the date of last dose/COVID-19 diagnosis and the date of this study vaccination should be 3 to 24 months.
- The participant and/or his legally acceptable representative 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;
Key exclusion criteria (21 listed)
- For Subgroup 1 in Cohort 1 only: 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 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;
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 |
| SCTV01Eintramuscular injection | Biological | Cohort 1: SCTV01E, Cohort 2: SCTV01E |
| Sinopharm inactivated COVID-19 vaccineintramuscular injection | Biological | Cohort 1: Active comparator |
| Comirnatyintramuscular injection | Biological | Cohort 2: Active comparator |
Primary outcome
GMT of nAb against Delta variant on Day 28
Time frame: Day 28 after the study vaccination
GMT of nAb against Omicron variant on Day 28
Time frame: Day 28 after the study vaccination
10 secondary outcomes
GMT of nAb against Delta variant on Day 180
Time frame: Day 180 after the study vaccination
GMT of nAb against Omicron variant on Day 180
Time frame: Day 180 after the study vaccination
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28
Time frame: Day 28 after the study vaccination
Seroresponse rates of nAb to Delta variant on Day 28.
Time frame: Day 28 after the study vaccination
Seroresponse rates of nAb to Omicron variant on Day 28.
Time frame: Day 28 after the study vaccination
Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7
Time frame: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28
Time frame: Day 0 to Day 28 after the study vaccination
Incidence and severity of SAEs and AESIs of SCTV01C within 180 days
Time frame: Day 0 to Day 180 after the study vaccination
Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7
Time frame: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28
Time frame: Day 0 to Day 28 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 10 Apr 2023.
- Derived from this study: PubMed 37731938Hannawi S, Yan L, Saifeldin L, Abuquta A, Alamadi A, Mahmoud SA, Hassan A, Zhang M, Gao C, Chen Y, Gai W, Xie L. Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial. EClinicalMedicine. 2023 Sep 8;64:102195. doi: 10.1016/j.eclinm.2023.102195. eCollection 2023 Oct.
- Derived from this study: PubMed 36598621Wang R, Huang H, Yu C, Sun C, Ma J, Kong D, Lin Y, Zhao D, Zhou S, Lu J, Cao S, Zhang Y, Luo C, Li X, Wang Y, Xie L. A spike-trimer protein-based tetravalent COVID-19 vaccine elicits enhanced breadth of neutralization against SARS-CoV-2 Omicron subvariants and other variants. Sci China Life Sci. 2023 Aug;66(8):1818-1830. doi: 10.1007/s11427-022-2207-7. Epub 2022 Dec 30.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCTV01C, SCTV01E and Sinopharm inactivated COVID-19 vaccine in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd. at 1 site in United Arab Emirates.
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 8 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 nAb against Delta variant on Day 28 (time frame: Day 28 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?
On the ClinicalTrials.gov record for NCT05323461, which also lists 2 linked publications.
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 10 Apr 2023.