A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

Study Overview
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Brief Summary
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It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.

Official Title
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A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Biological: V-01/V-01-B5
* Biological: V-01-351/V-01-B5
* Biological: V-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 -59 years old at time of consent, male or female; Normal body temperature; Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-01/V-01-B5 group<br>One dose of V-01/V-01-B5 | Biological: V-01/V-01-B5<br>* Contains 10μg of V-01 and 10μg of V-01-B5<br>|
| Experimental: V-01-351/V-01-B5 group<br>One dose of V-01-351/V-01-B5 | Biological: V-01-351/V-01-B5<br>* Contains 10μg of V-01-351 and 10μg of V-01-B5<br>|
| Experimental: V-01 group<br>One dose of V-01 | Biological: V-01<br>* Contains 10μg of V-01<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event (AE) | Observe the AEs occurs at different time point after vaccination | 30 minutes after vaccination | 
| AEs | Observe the AEs occurs at different time point after vaccination | 0-7 days after vaccination | 
| AEs | Observe the AEs occurs at different time point after vaccination | 0-28 days after vaccination | 
| Serious adverse event (SAE) and adverse event of special interest (AESI) | Observe the SAE and AESI after vaccination | Within 12 months after vaccination | 
| Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5 | Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5) | 28 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | 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) | Until 12 months after vaccination | 
| Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT) | Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT | Until 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 | Until 12 months after vaccination | 
| Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level | Anti-SARS-CoV-2 RBD antibody level after vaccination | Until 12 months after vaccination |