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The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.
The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations (1-dose of SCTV01C and 1-dose of SCTV01E, or 2-dose of SCTV01E, or 1-dose of Sinopharm inactivated COVID-19 vaccine and 1-dose of SCTV01E, 1-dose of Comirnaty and 1-dose of SCTV01E).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTV01C | Experimental | Participants will receive one dose of SCTV01C on Day 0 and one dose of SCTV01E on Day 180. |
|
| SCTV01E | Experimental | Participants will receive one dose of SCTV01E on Day 0 and one dose of SCTV01E on Day 180. |
|
| Sinopharm inactivated COVID-19 vaccine | Active Comparator | Participants will receive one dose of Sinopharm inactivated COVID-19 vaccine on Day 0 and one dose of SCTV01E on Day 180. |
|
| Comirnaty | Active Comparator | Participants will receive one dose of Comirnaty on Day 0 and one dose of SCTV01E on Day 180. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTV01C | Biological | Day 0; intramuscular injection |
| |
| SCTV01E |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 28. | Day 28 after the study vaccination | |
| GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 28. | Day 28 after the study vaccination | |
| GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 208. | Day 208 after the study vaccination | |
| GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 208. | Day 208 after the study vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 and Day 208. | Day 28 and D208 after the study vaccination | |
| Seroresponse rates of neutralizing antibodiesto Delta variant on Day 28. | Day 28 after the study vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Ke | Contact | +86 18501160269 | min_ke@sinocelltech.com | |
| Yongpan Fu | Contact | +86 18612320378 | yongpan_fu@sinocelltech.com |
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| Biological |
Day 0; intramuscular injection |
|
| Sinopharm inactivated COVID-19 vaccine | Biological | Day 0; intramuscular injection |
|
| Comirnaty | Biological | Day 0; intramuscular injection |
|
| SCTV01E | Biological | Day 180; intramuscular injection |
|
| Seroresponse rates of neutralizing antibodies to Omicron variant rates on Day 28. | Day 28 after the study vaccination |
| Seroresponse rates of neutralizing antibodies to Delta variant on Day 208. | Day 208 after the study vaccination |
| Seroresponse rates of neutralizing antibodies to Omicron variant on Day 208. | Day 208 after the study vaccination |
| Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7 and Day 180 to Day 187. | Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination |
| Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28 and Day 180 to Day 208. | Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination |
| Incidence and severity of SAEs and AESIs of SCTV01C within 365 days. | Day 0 to Day 365 after the 1st study vaccination |
| Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7 and Day 180 to Day 187. | Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination |
| Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28 and Day 180 to Day 208. | Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination |
| Incidence and severity of SAEs and AESIs of SCTV01E within 365 days. | Day 0 to Day 365 after the 1st study vaccination |
| 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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