Clinical trial NCT05585567: A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5
Official title: A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: COVID-19 Pandemic
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 -59 years old at time of consent, male or female;
* Normal body temperature;
* Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
* 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.

Primary outcomes:
measure: Adverse Event (AE)
timeFrame: 30 minutes after vaccination
measure: AEs
timeFrame: 0-7 days after vaccination
measure: AEs
timeFrame: 0-28 days after vaccination
measure: Serious adverse event (SAE) and adverse event of special interest (AESI)
timeFrame: Within 12 months after vaccination
measure: Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: Neutralizing antibody GMT of other SARS-CoV-2 variants
timeFrame: Until 12 months after vaccination
measure: Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
timeFrame: Until 12 months after vaccination
measure: Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
timeFrame: Until 12 months after vaccination
measure: Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level
timeFrame: Until 12 months after vaccination
Other outcomes:
Locations:
city: Shaoguan
country: China
facility: Shaoguan Hospital of Chinese Medicine
state: Guangdong
Study officials:
References: