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

November 3, 2022 updated by: Livzon Pharmaceutical Group Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Event (AE)
Time Frame: 30 minutes after vaccination
Observe the AEs occurs at different time point after vaccination
30 minutes after vaccination
AEs
Time Frame: 0-7 days after vaccination
Observe the AEs occurs at different time point after vaccination
0-7 days after vaccination
AEs
Time Frame: 0-28 days after vaccination
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)
Time Frame: Within 12 months after vaccination
Observe the SAE and AESI after vaccination
Within 12 months 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)
28 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neutralizing antibody GMT of other SARS-CoV-2 variants
Time Frame: Until 12 months after vaccination
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)
Time Frame: Until 12 months after vaccination
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)
Time Frame: Until 12 months after vaccination
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
Time Frame: Until 12 months after vaccination
Anti-SARS-CoV-2 RBD antibody level after vaccination
Until 12 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Livzon Pharmaceutical Group Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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