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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05374954
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : June 1, 2022
Sponsor:
Collaborators:
Beijing Institute of Biological Products Co Ltd.
Hunan Provincial Center for Disease Control and Prevention
Information provided by (Responsible Party):
China National Biotec Group Company Limited

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated Biological: COVID-19 Vaccine (Vero Cell), Inactivated Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : May 10, 2022
Estimated Primary Completion Date : October 10, 2022
Estimated Study Completion Date : November 10, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A1:one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: A2:one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: A3:one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: A4:one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: B1:one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: B2:one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: B3:one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: B4:one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: C1:two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: C2:two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: C3:two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: C4:two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: C5:two doses, 18-59 years old, more than 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: C6:two doses, 18-59 years old, more than 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: D1:two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: D2:two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: D3:two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: D4:two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: E1:two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: E2:two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: E3:two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: E4:two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: E5:two doses, 18-59 years old, more than 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: E6:two doses, 18-59 years old, more than 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: F1:two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: F2:two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Experimental: F3:two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle

Active Comparator: F4:two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
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
intramuscular injection in the deltoid muscle




Primary Outcome Measures :
  1. The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 28 after vaccination ]
  2. The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 28 after vaccination ]
  3. Incidence of adverse reactions [ Time Frame: within 28 days after vaccination ]

Secondary Outcome Measures :
  1. The GMT of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 14 after vaccination ]
  2. The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 14 after vaccination ]
  3. Specific cellular immune response [ Time Frame: within 28 days after vaccination ]
  4. The neutralizing antibody GMT [ Time Frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination ]
  5. The proportion of subjects with neutralizing antibody GMT ≥1:16,≥1:32 and ≥1:64 [ Time Frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination ]
  6. The incidence of any adverse reactions/events [ Time Frame: 28 days after each immunization ]
  7. The incidence of serious adverse events (SAE) and adverse events special interest (AESI) [ Time Frame: From the beginning of the first dose to 12 months after vaccination ]

Other Outcome Measures:
  1. The neutralizing antibody GMT to different variants of SARS-CoV-2 [ Time Frame: On Day 28 after vaccination ]
  2. The IgG antibody lever against Omicron SARS-CoV-2 [ Time Frame: On Day 14 and Day 28 after vaccination ]
  3. The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19 [ Time Frame: From 14 day after vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374954


Contacts
Layout table for location contacts
Contact: Junshi Zhao, Master +8617788903138 ymlc02@hncdc.com

Locations
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China, Hunan
Linli County Center for Disease Control and Prevention Recruiting
Changde, Hunan, China, 415200
Contact: Hao Gong    +8619192126559    370473323@qq.com   
Changning Center for Disease Control and Prevention Recruiting
Changning, Hunan, China, 421500
Contact: Dewei Teng    +8618216007118    657866891@qq.com   
You County Center for Disease Control and Prevention Recruiting
Zhuzhou, Hunan, China, 412300
Contact: Yi Zhou    +8613787821797    1647138572@qq.com   
Sponsors and Collaborators
China National Biotec Group Company Limited
Beijing Institute of Biological Products Co Ltd.
Hunan Provincial Center for Disease Control and Prevention
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Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT05374954    
Other Study ID Numbers: CNBG-BIBP-O-2022004
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Biotec Group Company Limited:
COVID-19
vaccine
inactivated vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs