Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 13, 2022

Interventions

  • Biological: V-01D-351
    • One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
  • Biological: V-01D-351
    • One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
  • Biological: CoronaVac
    • One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
  • Biological: CoronaVac
    • One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago

Arms, Groups and Cohorts

  • Experimental: Cohort 1
  • Experimental: Cohort 2
  • Active Comparator: Cohort 3
  • Active Comparator: Cohort 4

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • AEs
    • Time Frame: 30 minutes, 0-7 days, 0-28 days after vaccination
    • Observe the AEs occurs at different time point after vaccination
  • SAE and AESI
    • Time Frame: Within 12 months after vaccination
    • Observe the SAE and AESI after vaccination

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Livzon Pharmaceutical Group Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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