Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 (COVID-19)

• ClinicalTrials.gov Identifier: NCT05583357
• Recruitment Status: Active, not recruiting
• First Posted: October 17, 2022
• Last Update Posted: October 19, 2022
• Sponsor: Livzon Pharmaceutical Group Inc.
• Information provided by (Responsible Party): Livzon Pharmaceutical Group Inc.

Tracking Information

• First Submitted Date: October 13, 2022
• First Posted Date: October 17, 2022
• Last Update Posted Date: October 19, 2022
• Actual Study Start Date: August 15, 2022
• Actual Primary Completion Date: September 13, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 13, 2022)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 13, 2022)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: COVID-19 Pandemic

Intervention

• 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

Study Arms

• Experimental: Cohort 1
  Intervention: Biological: V-01D-351
• Experimental: Cohort 2
  Intervention: Biological: V-01D-351
• Active Comparator: Cohort 3
  Intervention: Biological: CoronaVac
• Active Comparator: Cohort 4
  Intervention: Biological: CoronaVac

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 13, 2022): 40
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: August 10, 2023
• Actual Primary Completion Date: September 13, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05583357
• Other Study ID Numbers: V-01D-351-Booster-03
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Livzon Pharmaceutical Group Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Livzon Pharmaceutical Group Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Livzon Pharmaceutical Group Inc.
• Verification Date: October 2022