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

Primary Purpose

COVID-19 Pandemic

Status

Active

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

V-01/V-01-B5

V-01-351/V-01-B5

V-01

About this trial

This is an interventional prevention trial for COVID-19 Pandemic

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Shaoguan Hospital of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

V-01/V-01-B5 group

V-01-351/V-01-B5 group

V-01 group

Arm Description

One dose of V-01/V-01-B5

One dose of V-01-351/V-01-B5

One dose of V-01

Outcomes

Primary Outcome Measures

Adverse Event (AE)

Observe the AEs occurs at different time point after vaccination

AEs

Observe the AEs occurs at different time point after vaccination

AEs

Observe the AEs occurs at different time point after vaccination

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

Observe the SAE and AESI 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)

Secondary Outcome Measures

Neutralizing antibody GMT of other SARS-CoV-2 variants

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)

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)

Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT

Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level

Anti-SARS-CoV-2 RBD antibody level after vaccination

Full Information

NCT ID

NCT05585567

First Posted

October 13, 2022

Last Updated

November 3, 2022

Sponsor

Livzon Pharmaceutical Group Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05585567

Brief Title

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

Acronym

COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 16, 2022 (Actual)

Primary Completion Date

October 14, 2022 (Actual)

Study Completion Date

September 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Livzon Pharmaceutical Group Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pandemic

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V-01/V-01-B5 group

Arm Type

Experimental

Arm Description

One dose of V-01/V-01-B5

Arm Title

V-01-351/V-01-B5 group

Arm Type

Experimental

Arm Description

One dose of V-01-351/V-01-B5

Arm Title

V-01 group

Arm Type

Experimental

Arm Description

One dose of V-01

Intervention Type

Biological

Intervention Name(s)

V-01/V-01-B5

Intervention Description

Contains 10μg of V-01 and 10μg of V-01-B5

Intervention Type

Biological

Intervention Name(s)

V-01-351/V-01-B5

Intervention Description

Contains 10μg of V-01-351 and 10μg of V-01-B5

Intervention Type

Biological

Intervention Name(s)

V-01

Intervention Description

Contains 10μg of V-01

Primary Outcome Measure Information:

Title

Adverse Event (AE)

Description

Observe the AEs occurs at different time point after vaccination

Time Frame

30 minutes after vaccination

Title

AEs

Description

Observe the AEs occurs at different time point after vaccination

Time Frame

0-7 days after vaccination

Title

AEs

Description

Observe the AEs occurs at different time point after vaccination

Time Frame

0-28 days after vaccination

Title

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

Description

Observe the SAE and AESI after vaccination

Time Frame

Within 12 months after vaccination

Title

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

Description

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

Time Frame

28 days after vaccination

Secondary Outcome Measure Information:

Title

Neutralizing antibody GMT of other SARS-CoV-2 variants

Description

Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)

Time Frame

Until 12 months after vaccination

Title

Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)

Description

Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT

Time Frame

Until 12 months after vaccination

Title

Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)

Description

Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT

Time Frame

Until 12 months after vaccination

Title

Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level

Description

Anti-SARS-CoV-2 RBD antibody level after vaccination

Time Frame

Until 12 months after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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; 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.

Facility Information:

Facility Name

Shaoguan Hospital of Chinese Medicine

City

Shaoguan

State/Province

Guangdong

ZIP/Postal Code

512000

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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