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

COVID-19 Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05374954
• Other study ID #: CNBG-BIBP-O-2022004
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 10, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: June 2023
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4200
• Est. completion date: November 10, 2023
• Est. primary completion date: September 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
• COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle

Locations

Country	Name	City	State
China	Linli County Center for Disease Control and Prevention	Changde	Hunan
China	Changning Center for Disease Control and Prevention	Changning	Hunan
China	Ningxiang Center for Disease Control and Prevention	Changsha	Hunan
China	Outpatient Department of Hunan Provincial Center for Disease Control and Prevention	Changsha	Hunan
China	Loudi Public Health Hospital	Loudi	Hunan
China	Xiangtan Center for Disease Control and Prevention	Xiangtan	Hunan
China	Luxi County Center for Disease Control and Prevention	Xiangxi	Hunan
China	Xiangxiang Center for Disease Control and Prevention	Xiangxiang	Hunan
China	Huarong County Center for Disease Control and Prevention	Yueyang	Hunan
China	You County Center for Disease Control and Prevention	Zhuzhou	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co Ltd., Hunan Provincial Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The neutralizing antibody GMT to different variants of SARS-CoV-2		On Day 28 after vaccination
Other	The IgG antibody lever against Omicron SARS-CoV-2		On Day 14 and Day 28 after vaccination
Other	The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19		From 14 day after vaccination
Primary	The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2		On Day 28 after vaccination
Primary	The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2		On Day 28 after vaccination
Primary	Incidence of adverse reactions		within 28 days after vaccination
Secondary	The GMT of neutralizing antibody against Omicron SARS-CoV-2		On Day 14 after vaccination
Secondary	The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2		On Day 14 after vaccination
Secondary	Specific cellular immune response		within 28 days after vaccination
Secondary	The neutralizing antibody GMT		on 3rd month, 6th month, 9th month, and 12th month after vaccination
Secondary	The proportion of subjects with neutralizing antibody GMT =1:16,=1:32 and =1:64		on 3rd month, 6th month, 9th month, and 12th month after vaccination
Secondary	The incidence of any adverse reactions/events		28 days after each immunization
Secondary	The incidence of serious adverse events (SAE) and adverse events special interest (AESI)		From the beginning of the first dose to 12 months after vaccination