COVID-19: Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cohort 1
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Biological: V-01D-351
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
|
Experimental: Cohort 2
|
Biological: V-01D-351
One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
|
Active Comparator: Cohort 3
|
Biological: CoronaVac
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
|
Active Comparator: Cohort 4
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Biological: CoronaVac
One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18 years and older at time of consent, male or female;
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Normal body temperature;
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Meet either of the following conditions:
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Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
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Received completed 3 doses of CoronaVac 5-9 months ago;
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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;
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Be able and willing to complete the study during the entire study and follow-up period;
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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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Serious chronic diseases or uncontrolled diseases;
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Uncontrolled neurological disorders, epilepsy;
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Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
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Patients with congenital or acquired immunodeficiency;
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History of severe allergy or be allergic to any components of the test vaccines;
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History of hereditary hemorrhagic tendency or coagulation dysfunction;
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Patients with malignant tumors and other patients have a life expectancy less than 1 year;
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Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
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History of previous COVID-19 infection;
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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;
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Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
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Those considered by the investigator as inappropriate to participate in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Shaoguan Hospital of Chinese Medicine | Shaoguan | Guangdong | China | 512000 |
Sponsors and Collaborators
- Livzon Pharmaceutical Group Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V-01D-351-Booster-03