Clinical trial NCT05374954: Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above
Official title: Safety and Immunogenicity Study on Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above Vaccinated the Prototype Inactivated COVID-19 Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
vaccine
inactivated vaccine
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Beijing Institute of Biological Products Co Ltd.
name: Hunan Provincial Center for Disease Control and Prevention
First posted: 2022-05-16
Enrollment: 4200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double blind, positive controlled study to evaluate the safety and immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above who have been vaccinated with 2 or 3 doses of COVID-19 Vaccine (Vero Cell), Inactivated manufactured by Beijing Institute of Biological Products, Co., Ltd.

Detailed description: This is a randomized, double blind, positive controlled study to evaluate the safety and immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above who have been vaccinated with 2 or 3 doses of COVID-19 Vaccine (Vero Cell), Inactivated manufactured by Beijing Institute of Biological Products, Co., Ltd. According to subject's age (18-59 vs 60 and above), doses of vaccination history ( 2 doses vs 3 doses), and vaccination interval, the subjects will be stratified and assigned randomly to the study groups ( Omicron inactivated COVID-19 Vaccine) or the control groups ( Prototype inactivated COVID-19 Vaccine) in a 2:1 ratio. All subjects will receive single dose or two doses of vaccine with a interval of 28 days. The occurrence of adverse events within 28 days and serious adverse events within 12 months after vaccination will be observed. The serum antibody levels, cellular immune responses will be analyzed at different time points.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 18 years old and above.
* By asking for medical history and physical examination, the investigator judged that the health condition is well.
* Has been vaccinated 2 or 3 doses of inactivated COVID-19 vaccine manufactured by BIBP more than 3 months.
* Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
* During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
* With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

* Confirmed or suspected cases of SARS-CoV-2 Infection.
* Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
* Received one dose or more than 3 doses of inactivated COVID-19 vaccine manufactured by BIBP
* Received COVID-19 vaccine manufactured bu other companies (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.)
* Axillary body temperature \> 37.3 ℃ before vaccination
* Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site inquiry).
* History of hospital-diagnosed thrombocytopenia or other coagulation disorder
* Known immunological impairment or low level with hospital diagnosis
* History of uncontrolled epilepsy, other progressive neurological disorders, or Guillain-Barre syndrome (self-report, on-site inquiry).
* Known or suspected concomitant serious diseases include: respiratory disease, acute infection or active chronic disease, liver and kidney disease, severe diabetes, malignant tumor, infection or allergic skin disease, HIV infection.
* Severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension, etc.) diagnosed by the hospital, active chronic respiratory disease
* Received live attenuated vaccine within 1 month before enrollment.
* Received other vaccines within 14 days before enrollment.
* Be participating in or plan to participate in other vaccine clinical trials during this study.
* Contraindications related to vaccination as considered by other investigators.

Primary outcomes:
measure: The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
timeFrame: On Day 28 after vaccination
measure: The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
timeFrame: On Day 28 after vaccination
measure: Incidence of adverse reactions
timeFrame: within 28 days after vaccination
Secondary outcomes:
measure: The GMT of neutralizing antibody against Omicron SARS-CoV-2
timeFrame: On Day 14 after vaccination
measure: The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
timeFrame: On Day 14 after vaccination
measure: Specific cellular immune response
timeFrame: within 28 days after vaccination
measure: The neutralizing antibody GMT
timeFrame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
measure: The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
timeFrame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
measure: The incidence of any adverse reactions/events
timeFrame: 28 days after each immunization
measure: The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
timeFrame: From the beginning of the first dose to 12 months after vaccination
Other outcomes:
measure: The neutralizing antibody GMT to different variants of SARS-CoV-2
timeFrame: On Day 28 after vaccination
measure: The IgG antibody lever against Omicron SARS-CoV-2
timeFrame: On Day 14 and Day 28 after vaccination
measure: The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19
timeFrame: From 14 day after vaccination
Locations:
city: Changde
country: China
facility: Linli County Center for Disease Control and Prevention
state: Hunan
city: Changning
country: China
facility: Changning Center for Disease Control and Prevention
state: Hunan
city: Changsha
country: China
facility: Ningxiang Center for Disease Control and Prevention
state: Hunan
city: Changsha
country: China
facility: Outpatient Department of Hunan Provincial Center for Disease Control and Prevention
state: Hunan
city: Loudi
country: China
facility: Loudi Public Health Hospital
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Center for Disease Control and Prevention
state: Hunan
city: Xiangxiang
country: China
facility: Xiangxiang Center for Disease Control and Prevention
state: Hunan
city: Xiangxi
country: China
facility: Luxi County Center for Disease Control and Prevention
state: Hunan
city: Yueyang
country: China
facility: Huarong County Center for Disease Control and Prevention
state: Hunan
city: Zhuzhou
country: China
facility: You County Center for Disease Control and Prevention
state: Hunan
Study officials:
References: