Clinical trial NCT05583357: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: COVID-19 Pandemic
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Neutralizing antibody GMT of Omicron BA.5
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: Neutralizing antibody GMT of other SARS-CoV-2 variants
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: Total IgG antibody level
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: Spike protein antibody level
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: RBD antibody level
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: Specific cytokine secretion levels
timeFrame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
measure: AEs
timeFrame: 30 minutes, 0-7 days, 0-28 days after vaccination
measure: SAE and AESI
timeFrame: Within 12 months after vaccination
Other outcomes:
Locations:
city: Shaoguan
country: China
facility: Shaoguan Hospital of Chinese Medicine
state: Guangdong
Study officials:
References: