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| Name | Class |
|---|---|
| Guangdong Center for Disease Prevention and Control | OTHER_GOV |
| Simoon Record Pharma Information Consulting Co., Ltd. | INDUSTRY |
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This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01.
The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The plan is to booster immunize the participants previously in 10μg test group in V-01 clinical trial phase I, 48 participants are planned to be enrolled. The actual case number will be calculated by the participants who signed the ICF and got actual inoculation with the third dose.
Vaccination and follow-up:
Three to six months after the two doses of V-01 (10 μg) were vaccinated, the participants received a booster dose of investigational vaccine (V-01, 10 μg) at the deltoid muscle of the upper arm.
Perform safety and immunogenicity related inspections in accordance with the schedule in the plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-01 COVID-19 Vaccine | Experimental | One dose administrated by intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant SARS-CoV-2 Fusion Protein Vaccine | Biological | The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Endpoints |
| 14 days after booster immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints |
| Day 0-7 after booster immunization, 6 months after booster immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Jikai | Guangdong Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Center for Disease Control and Prevention | Guangzhou | Guangdong | 511430 | 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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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |