Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351
- Conditions
- COVID-19 Pandemic
- Interventions
- Biological: V-01D-351Biological: CoronaVac
- Registration Number
- NCT05583357
- Lead Sponsor
- Livzon Pharmaceutical Group Inc.
- 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 available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
-
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;
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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;
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 V-01D-351 - Cohort 4 CoronaVac - Cohort 2 V-01D-351 - Cohort 3 CoronaVac -
- Primary Outcome Measures
Name Time Method Neutralizing antibody GMT of Omicron BA.5 28 days after vaccination Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
- Secondary Outcome Measures
Name Time Method Neutralizing antibody GMT of other SARS-CoV-2 variants 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) 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
SAE and AESI Within 12 months after vaccination Observe the SAE and AESI after vaccination
RBD antibody level 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination Anti-SARS-CoV-2 RBD antibody level
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT) 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 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 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination Antibody level of anti-SARS-CoV-2 spike protein
AEs 30 minutes, 0-7 days, 0-28 days after vaccination Observe the AEs occurs at different time point after vaccination
Specific cytokine secretion levels 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination Specific cytokine secretion levels such as IFN-γ
Trial Locations
- Locations (1)
Shaoguan Hospital of Chinese Medicine
🇨🇳Shaoguan, Guangdong, China