Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is a Single Arm, Open Label Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of V-01-351/V-01D Bivalence Vaccine in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines. A total of 20 participants were enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-01-351/V-01D bivalence vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant SARS-CoV-2 Beta Variant Fusion Protein Vaccine/Recombinant SARS-CoV-2 Delta Variant 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 |
|---|---|---|
| GMT of neutralizing antibody | GMT of neutralizing antibody (pesudovirus/live virus) of SARS-CoV-2 Omicron variant after 14 days and 28 days administered with V-01-351/V-01D Bivalence Vaccine | 28 days after booster immunization |
| GMI of neutralizing antibody | GMI of neutralizing antibody (pesudovirus/live virus) of SARS-CoV-2 Omicron variant after 14 days and 28 days administered with V-01-351/V-01D Bivalence Vaccine | 28 days after booster immunization |
| Seroconversion rate of neutralizing antibody | Seroconversion rate of neutralizing antibody (pesudovirus/live virus) of SARS-CoV-2 Omicron variant after 14 days and 28 days administered with V-01-351/V-01D Bivalence Vaccine | 28 days after booster immunization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Confirmed COVID-19 cases, or positive for SARS-CoV-2 test by RT-PCR. 2. History of previous SARS infection. 3. History of severe allergy to any vaccine or any ingredient of the vaccine including aluminum adjuvant, e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc..
4. People who currently suffer from the following diseases:
5. Received attenuated live vaccine within 28 days before the vaccination or any subunit vaccines and inactivated vaccines within 14 days before the vaccination.
6. Injection of immunoglobulin and/or other blood products within 3 months before the administration of study vaccine; or with the plan to use such product within 6 month after immunization.
7. Pregnant (including positive urine pregnancy test for women of childbearing age) or breastfeeding women. Or women or their partners who have a pregnancy plan within 3 months after the trial vaccination.
8. Have participated in or are participating in other COVID-19 related clinical trials, or are participating in other drug clinical trials; 9. Those considered by the investigator as inappropriate to participate in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoguan Hospital of Chinese Medicine | Shaoguan | Guangdong | 521000 | China |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |