Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above

China National Biotec Group (CNBG)

Status and phase: Active, not recruiting; Phase 3

Conditions: COVID-19

Treatments: Biological: COVID-19 Vaccine (Vero Cell), Inactivated; Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05374954

CNBG-BIBP-O-2022004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,200 participants in 28 patient groups

A1：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

A2：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

B1：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

B2：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

B3：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

B4：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination

Experimental group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination

Active Comparator group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination

Experimental group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination

Active Comparator group

Description:

subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine (Vero Cell), Inactivated