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

Sponsor
Livzon Pharmaceutical Group Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05585567
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
11.8
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: V-01/V-01-B5
  • Biological: V-01-351/V-01-B5
  • Biological: V-01
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 16, 2022
Actual Primary Completion Date :
Oct 14, 2022
Anticipated Study Completion Date :
Sep 11, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adverse Event (AE) [30 minutes after vaccination]

    Observe the AEs occurs at different time point after vaccination

  2. AEs [0-7 days after vaccination]

    Observe the AEs occurs at different time point after vaccination

  3. AEs [0-28 days after vaccination]

    Observe the AEs occurs at different time point after vaccination

  4. Serious adverse event (SAE) and adverse event of special interest (AESI) [Within 12 months after vaccination]

    Observe the SAE and AESI after vaccination

  5. Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5 [28 days after vaccination]

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

Secondary Outcome Measures

  1. Neutralizing antibody GMT of other SARS-CoV-2 variants [Until 12 months after vaccination]

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

  2. Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT) [Until 12 months after vaccination]

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

  3. Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT) [Until 12 months after vaccination]

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

  4. Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level [Until 12 months after vaccination]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shaoguan Hospital of Chinese Medicine Shaoguan Guangdong China 512000

Sponsors and Collaborators

  • Livzon Pharmaceutical Group Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier:
NCT05585567
Other Study ID Numbers:
  • V-01-B5- Booster-01
First Posted:
Oct 19, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Nov 7, 2022