COVID-19 Pandemic
Conditions
Brief summary
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.
Interventions
BIOLOGICALV-01D-351
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
BIOLOGICALCoronaVac
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
Sponsors
Livzon Pharmaceutical Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 years and older at time of consent, male or female; * Normal body temperature; * Meet either of the following conditions: 1. Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago; 2. Received completed 3 doses of CoronaVac 5-9 months ago; * 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
* Serious chronic diseases or uncontrolled diseases; * Uncontrolled neurological disorders, epilepsy; * Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks; * Patients with congenital or acquired immunodeficiency; * History of severe allergy or be allergic to any components of the test vaccines; * History of hereditary hemorrhagic tendency or coagulation dysfunction; * Patients with malignant tumors and other patients have a life expectancy less than 1 year; * Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol; * History of previous COVID-19 infection; * Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study; * Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials; * Those considered by the investigator as inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody GMT of Omicron BA.5 | 28 days after vaccination | Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific cytokine secretion levels | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Specific cytokine secretion levels such as IFN-γ |
| AEs | 30 minutes, 0-7 days, 0-28 days after vaccination | Observe the AEs occurs at different time point after vaccination |
| SAE and AESI | Within 12 months after vaccination | Observe the SAE and AESI after vaccination |
| Neutralizing antibody GMT of other SARS-CoV-2 variants | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5) |
| RBD antibody level | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Anti-SARS-CoV-2 RBD antibody level |
| Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT) | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT |
| Total IgG antibody level | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Total IgG antibody level of SARS-CoV-2 |
| Spike protein antibody level | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Antibody level of anti-SARS-CoV-2 spike protein |
| Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT) | 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination | Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT |
Countries
China
Outcome results
None listed