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

NCT05374954 | Unknown Phase 3

• 1 other identifier: CNBG-BIBP-O-2022004
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 10

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.

Conditions

COVID-19

Keywords

COVID-19; vaccine; inactivated vaccine

Outcome Measures

Primary Outcomes (3)

• The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2

  On Day 28 after vaccination

• The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2

  On Day 28 after vaccination

• Incidence of adverse reactions

  within 28 days after vaccination

Secondary Outcomes (7)

• The GMT of neutralizing antibody against Omicron SARS-CoV-2

  On Day 14 after vaccination

• The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2

  On Day 14 after vaccination

• Specific cellular immune response

  within 28 days after vaccination

• The neutralizing antibody GMT

  on 3rd month, 6th month, 9th month, and 12th month after vaccination

• 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

Other Outcomes (3)

• The neutralizing antibody GMT to different variants of SARS-CoV-2

  On Day 28 after vaccination

• The IgG antibody lever against Omicron SARS-CoV-2

  On Day 14 and Day 28 after vaccination

• The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19

  From 14 day after vaccination

Study Arms (28)

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

EXPERIMENTAL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EXPERIMENTAL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EXPERIMENTAL

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

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

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

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

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

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

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

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

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

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

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

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

Interventions

Omicron COVID-19 Vaccine (Vero Cell), Inactivated BIOLOGICAL

intramuscular injection in the deltoid muscle

A1：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination; A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination; B1：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination; B3：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination; C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination; C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination; C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination; D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination; D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination; E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination; E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination; E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination; F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination; F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination

COVID-19 Vaccine (Vero Cell), Inactivated BIOLOGICAL

intramuscular injection in the deltoid muscle

A2：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination; A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination; B2：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination; B4：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination; C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination; C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination; C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination; D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination; D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination; E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination; E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination; E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination; F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination; F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Hunan Provincial Center for Disease Control and Prevention: collaborator

Study Sites (10)

Linli County Center for Disease Control and Prevention

Changde, Hunan, 415200, China

Location

Changning Center for Disease Control and Prevention

Changning, Hunan, 421500, China

Location

Ningxiang Center for Disease Control and Prevention

Changsha, Hunan, China

Location

Outpatient Department of Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, China

Location

Loudi Public Health Hospital

Loudi, Hunan, China

Location

Xiangtan Center for Disease Control and Prevention

Xiangtan, Hunan, China

Location

Luxi County Center for Disease Control and Prevention

Xiangxi, Hunan, China

Location

Xiangxiang Center for Disease Control and Prevention

Xiangxiang, Hunan, China

Location

Huarong County Center for Disease Control and Prevention

Yueyang, Hunan, China

Location

You County Center for Disease Control and Prevention

Zhuzhou, Hunan, 412300, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 16, 2022
• Study Start: May 10, 2022
• Primary Completion: September 25, 2022
• Study Completion: November 10, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)