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It is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
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| Cohort 3 | Active Comparator |
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| Cohort 4 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-01D-351 | Biological | One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody 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) | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination |
| Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT) |
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Inclusion Criteria:
Adults aged 18 years and older at time of consent, male or female;
Normal body temperature;
Meet either of the following conditions:
Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
Be able and willing to complete the study during the entire study and follow-up period;
Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.
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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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
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| V-01D-351 | Biological | One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago |
|
| CoronaVac | Biological | One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago |
|
| CoronaVac | Biological | One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago |
|
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT |
| 7 days, 14 days, 28 days, 3 months, 6 months and 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 | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination |
| Total IgG antibody level | Total IgG antibody level of SARS-CoV-2 | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination |
| Spike protein antibody level | Antibody level of anti-SARS-CoV-2 spike protein | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination |
| RBD antibody level | Anti-SARS-CoV-2 RBD antibody level | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination |
| Specific cytokine secretion levels | Specific cytokine secretion levels such as IFN-γ | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination |
| AEs | Observe the AEs occurs at different time point after vaccination | 30 minutes, 0-7 days, 0-28 days after vaccination |
| SAE and AESI | Observe the SAE and AESI after vaccination | Within 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 |