Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above (COVID-19)

June 15, 2023 updated by: China National Biotec Group Company Limited

A Randomized, Double-Blinded, Cohort Clinical Study on Evaluating the Safety and Immunogenicity of Sequential Immunization of Two Doses of BIBP Inactivated COVID-19 Vaccine (Omicron), WIBP Inactivated COVID-19 Vaccine (Omicron) or Inactivated COVID-19 Vaccine (Prototype) in Population Aged 18 Years and Above Who Have Completed Two or Three Doses of Inactivated or mRNA Vaccine

This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1804

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ivan Hung, Clinical Professor
  • Phone Number: +852 2255 4049
  • Email: ivanhung@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age range: populations aged 18 years and above.
  • Judged by the investigator that the health condition is well after inquiry and physical examination.
  • Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for ≥ 3 months.
  • Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 7 months after enrollment. 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 is able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

  • Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
  • With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (self-report, on-site inquiry);
  • Has vaccinated with one or four doses and above COVID-19 vaccine;
  • Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃);
  • Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite enquiry);
  • Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry);
  • With known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry);
  • Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry);
  • Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry);
  • Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, Human Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test report if available);
  • With hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), acute attacks of chronic respiratory illness (self-report, onsite enquiry);
  • Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry);
  • Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry);
  • Participating or planning to participate in other interventional vaccine clinical trials during this study
  • Other vaccination-related contraindications considered by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1: BIBP Inactivated COVID-19 vaccine (Omicron)
subjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine
Biological: BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
Experimental: 2: WIBP Inactivated COVID-19 vaccine (Omicron)
subjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine
Biological: WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
Experimental: 3：BIBP Inactivated COVID-19 vaccine (Omicron)
subjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine
Biological: BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
Experimental: 4: WIBP Inactivated COVID-19 vaccine (Omicron)
subjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine
Biological: WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
Active Comparator: 5：Inactivated COVID-19 Vaccine (prototype)
subjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
Active Comparator: 6：Inactivated COVID-19 Vaccine (prototype)
subjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody
Time Frame: 28 days after sequential vaccination of 2 doses
28 days after sequential vaccination of 2 doses
The 4-fold rise rate of anti-omicron neutralizing antibody
Time Frame: 28 days after sequential vaccination of 2 doses
28 days after sequential vaccination of 2 doses

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The GMT of anti-omicron neutralizing antibody
Time Frame: 14 days after sequential vaccination of 2 doses
14 days after sequential vaccination of 2 doses
The 4-fold rise rate of anti-omicron neutralizing antibody
Time Frame: 14 days after sequential vaccination of 2 doses
14 days after sequential vaccination of 2 doses
Specific cellular immune response
Time Frame: within 28 days after vaccination
within 28 days after vaccination
The GMT of anti-omicron Immunoglobulin G (IgG) antibody
Time Frame: 28 days after sequential vaccination of 2 doses
28 days after sequential vaccination of 2 doses
The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time Frame: 28 days after sequential vaccination of 2 doses
28 days after sequential vaccination of 2 doses
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
on 3rd month, 6th month, 9th month, and 12th month after vaccination
The incidence of any adverse reactions/events
Time Frame: 28 days after each immunization
28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Time Frame: from 1st booster dose and up to 6 months following 2nd booster dose
from 1st booster dose and up to 6 months following 2nd booster dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19
Time Frame: From 14 day after vaccination
From 14 day after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Biotec Group Company Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong
Beijing Institute of Biological Products Co Ltd.
Wuhan Institute of Biological Products Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ivan Hung, Clinical Professor, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNBG-O-2022002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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