A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5 (COVID-19)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Biological: V-01/V-01-B5; Biological: V-01-351/V-01-B5; Biological: V-01

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shaoguan, Guangdong, China, 512000
      • Shaoguan Hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V-01/V-01-B5 group; One dose of V-01/V-01-B5	Biological: V-01/V-01-B5; Contains 10μg of V-01 and 10μg of V-01-B5
Experimental: V-01-351/V-01-B5 group; One dose of V-01-351/V-01-B5	Biological: V-01-351/V-01-B5; Contains 10μg of V-01-351 and 10μg of V-01-B5
Experimental: V-01 group; One dose of V-01	Biological: V-01; Contains 10μg of V-01

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Livzon Pharmaceutical Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): October 14, 2022
• Study Completion (Anticipated): September 11, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: V-01-B5- Booster-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No