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

Livzon Pharmaceutical Group Inc.1 site in 1 country48 target enrollmentSeptember 16, 2022

ConditionsCOVID-19 Pandemic

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: COVID-19 Pandemic
Sponsor: Livzon Pharmaceutical Group Inc.
Enrollment: 48
Locations: 1
Primary Endpoint: Serious adverse event (SAE) and adverse event of special interest (AESI)
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 16, 2022

End Date

September 11, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Livzon Pharmaceutical Group Inc.

Responsible Party

Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Serious adverse event (SAE) and adverse event of special interest (AESI)

Time Frame: Within 12 months after vaccination

Observe the SAE and AESI after vaccination

Adverse Event (AE)

Time Frame: 30 minutes after vaccination

Observe the AEs occurs at different time point after vaccination

AEs

Time Frame: 0-28 days after vaccination

Observe the AEs occurs at different time point after vaccination

Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5

Time Frame: 28 days after vaccination

Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)

Secondary Outcomes

Neutralizing antibody GMT of other SARS-CoV-2 variants(Until 12 months after vaccination)
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)(Until 12 months after vaccination)
Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level(Until 12 months after vaccination)
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)(Until 12 months after vaccination)