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Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 (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: NCT05583357
Recruitment Status : Active, not recruiting
First Posted : October 17, 2022
Last Update Posted : October 19, 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, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.

Condition or disease Intervention/treatment Phase
COVID-19 Pandemic Biological: V-01D-351 Biological: CoronaVac Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single Center, Randomized, Open-labeled, Blind Endpoint Evaluation, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 as a Booster Dose in Participants Aged 18 Years and Older Vaccinated 2-dose or 3-dose Inactivated COVID-19 Vaccine
Actual Study Start Date : August 15, 2022
Actual Primary Completion Date : September 13, 2022
Estimated Study Completion Date : August 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 Biological: V-01D-351
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
Experimental: Cohort 2 Biological: V-01D-351
One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Active Comparator: Cohort 3 Biological: CoronaVac
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
Active Comparator: Cohort 4 Biological: CoronaVac
One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago


Outcome Measures
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Primary Outcome Measures :
  1. Neutralizing antibody 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: 7 days, 14 days, 28 days, 3 months, 6 months and 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: 7 days, 14 days, 28 days, 3 months, 6 months and 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: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination ]
    Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT

  4. Total IgG antibody level [ Time Frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination ]
    Total IgG antibody level of SARS-CoV-2

  5. Spike protein antibody level [ Time Frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination ]
    Antibody level of anti-SARS-CoV-2 spike protein

  6. RBD antibody level [ Time Frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination ]
    Anti-SARS-CoV-2 RBD antibody level

  7. Specific cytokine secretion levels [ Time Frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination ]
    Specific cytokine secretion levels such as IFN-γ

  8. AEs [ Time Frame: 30 minutes, 0-7 days, 0-28 days after vaccination ]
    Observe the AEs occurs at different time point after vaccination

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 18 years and older at time of consent, male or female;
  • Normal body temperature;

  • Meet either of the following conditions:

    1. Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
    2. Received completed 3 doses of CoronaVac 5-9 months ago;
  • 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): NCT05583357


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: NCT05583357    
Other Study ID Numbers: V-01D-351-Booster-03
First Posted: October 17, 2022    Key Record Dates
Last Update Posted: October 19, 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
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases