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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: SCTV01C | Experimental | one dose of SCTV01C on D0 |
|
| Cohort 1: SCTV01E | Experimental | one dose of SCTV01E on D0 |
|
| Cohort 1: Active comparator | Active Comparator | one dose of Sinopharm inactivated COVID-19 vaccine on D0 |
|
| Cohort 2: SCTV01C | Experimental | one dose of SCTV01C on D0 |
|
| Cohort 2: SCTV01E | Experimental | one dose of SCTV01E on D0 |
|
| Cohort 2: Active comparator | Active Comparator | one dose of Comirnaty on D0 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTV01C | Biological | intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of nAb against Delta variant on Day 28 | Day 28 after the study vaccination | |
| GMT of nAb against Omicron variant on Day 28 | Day 28 after the study vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of nAb against Delta variant on Day 180 | Day 180 after the study vaccination | |
| GMT of nAb against Omicron variant on Day 180 | Day 180 after the study vaccination | |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Kuwait Hospital (Al Baraha Hospital) | Dubai | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37731938 | Derived | 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. | |
| 36598621 | Derived |
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| SCTV01E |
| Biological |
intramuscular injection |
|
| Sinopharm inactivated COVID-19 vaccine | Biological | intramuscular injection |
|
| Comirnaty | Biological | intramuscular injection |
|
| Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 |
| 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 | 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 | Day 28 after the study vaccination |
| Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7 | Day 0 to Day 7 after the study vaccination |
| Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28 | Day 0 to Day 28 after the study vaccination |
| Incidence and severity of SAEs and AESIs of SCTV01C within 180 days | Day 0 to Day 180 after the study vaccination |
| Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7 | Day 0 to Day 7 after the study vaccination |
| Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28 | Day 0 to Day 28 after the study vaccination |
| Wang 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000719256 | SCTV01C vaccine |
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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