Back to resultsExploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 (COVID-19)
Primary Purpose
COVID-19 Pandemic
Status
Active
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
V-01D-351
V-01D-351
CoronaVac
CoronaVac
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 Pandemic
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:
- Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
- 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.
Sites / Locations
- Shaoguan Hospital of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
Outcomes
Primary Outcome Measures
Neutralizing antibody GMT of Omicron BA.5
Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
Secondary Outcome Measures
Neutralizing antibody GMT of other SARS-CoV-2 variants
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)
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)
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT
Total IgG antibody level
Total IgG antibody level of SARS-CoV-2
Spike protein antibody level
Antibody level of anti-SARS-CoV-2 spike protein
RBD antibody level
Anti-SARS-CoV-2 RBD antibody level
Specific cytokine secretion levels
Specific cytokine secretion levels such as IFN-γ
AEs
Observe the AEs occurs at different time point after vaccination
SAE and AESI
Observe the SAE and AESI after vaccination
Full Information
NCT ID
NCT05583357
First Posted
October 13, 2022
Last Updated
October 16, 2022
Sponsor
Livzon Pharmaceutical Group Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05583357
Brief Title
Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351
Acronym
COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
August 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Livzon Pharmaceutical Group Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
Cohort 2
Arm Type
Experimental
Arm Title
Cohort 3
Arm Type
Active Comparator
Arm Title
Cohort 4
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
V-01D-351
Intervention Description
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
Intervention Type
Biological
Intervention Name(s)
V-01D-351
Intervention Description
One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Intervention Type
Biological
Intervention Name(s)
CoronaVac
Intervention Description
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
Intervention Type
Biological
Intervention Name(s)
CoronaVac
Intervention Description
One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Primary Outcome Measure Information:
Title
Neutralizing antibody GMT of Omicron BA.5
Description
Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
Time Frame
28 days after vaccination
Secondary Outcome Measure Information:
Title
Neutralizing antibody GMT of other SARS-CoV-2 variants
Description
Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
Description
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
Description
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
Total IgG antibody level
Description
Total IgG antibody level of SARS-CoV-2
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
Spike protein antibody level
Description
Antibody level of anti-SARS-CoV-2 spike protein
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
RBD antibody level
Description
Anti-SARS-CoV-2 RBD antibody level
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
Specific cytokine secretion levels
Description
Specific cytokine secretion levels such as IFN-γ
Time Frame
7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Title
AEs
Description
Observe the AEs occurs at different time point after vaccination
Time Frame
30 minutes, 0-7 days, 0-28 days after vaccination
Title
SAE and AESI
Description
Observe the SAE and AESI after vaccination
Time Frame
Within 12 months after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
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.
Facility Information:
Facility Name
Shaoguan Hospital of Chinese Medicine
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351
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