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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05585567
Recruitment Status : Active, not recruiting
First Posted : October 19, 2022
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

Study Description
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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
COVID-19 Pandemic Biological: V-01/V-01-B5 Biological: V-01-351/V-01-B5 Biological: V-01 Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 16, 2022
Actual Primary Completion Date : October 14, 2022
Estimated Study Completion Date : September 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adverse Event (AE) [ Time Frame: 30 minutes after vaccination ]
    Observe the AEs occurs at different time point after vaccination

  2. AEs [ Time Frame: 0-7 days after vaccination ]
    Observe the AEs occurs at different time point after vaccination

  3. AEs [ Time Frame: 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) [ Time Frame: Within 12 months after vaccination ]
    Observe the SAE and AESI after vaccination

  5. 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 Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05585567


Locations
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China, Guangdong
Shaoguan Hospital of Chinese Medicine
Shaoguan, Guangdong, China, 512000
Sponsors and Collaborators
Livzon Pharmaceutical Group Inc.
More Information
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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT05585567    
Other Study ID Numbers: V-01-B5- Booster-01
First Posted: October 19, 2022    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases