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It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-01/V-01-B5 group | Experimental | One dose of V-01/V-01-B5 |
|
| V-01-351/V-01-B5 group | Experimental | One dose of V-01-351/V-01-B5 |
|
| V-01 group | Experimental | One dose of V-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-01/V-01-B5 | Biological | Contains 10μg of V-01 and 10μg of V-01-B5 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Observe the AEs occurs at different time point after vaccination | 30 minutes after vaccination |
| AEs | Observe the AEs occurs at different time point after vaccination | 0-7 days after vaccination |
| AEs | Observe the AEs occurs at different time point after vaccination | 0-28 days after vaccination |
| Serious adverse event (SAE) and adverse event of special interest (AESI) | Observe the SAE and AESI after vaccination | Within 12 months after vaccination |
| Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5 | Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5) | 28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody GMT of other SARS-CoV-2 variants | Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5) | Until 12 months after vaccination |
| Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoguan Hospital of Chinese Medicine | Shaoguan | Guangdong | 512000 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| V-01-351/V-01-B5 |
| Biological |
Contains 10μg of V-01-351 and 10μg of V-01-B5 |
|
| V-01 | Biological | Contains 10μg of V-01 |
|
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT
| Until 12 months after vaccination |
| Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT) | Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT | Until 12 months after vaccination |
| Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level | Anti-SARS-CoV-2 RBD antibody level after vaccination | Until 12 months after vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |