A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)

May 26, 2022 updated by: National Vaccine and Serum Institute, China

A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above

A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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 (Anticipated)

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.
516

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 2

Contacts and Locations

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

Study Locations

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: population aged 18 years and above;
  • Judged by the investigator that the health condition is well after inquiry and physical examination;
  • Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
  • Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
  • Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;

Exclusion Criteria:

  • COVID-19 infection positive patients (including suspected or asymptomatic cases);
  • Have a history of SARS and MERS infection;
  • Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
  • Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
  • Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
  • History of thrombocytopenia or other coagulation disorders;
  • Patients with known immunological impairment or immunocompromised.
  • Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment
  • Have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (HIV) infection (test report available);
  • Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic blood pressure 95 mmHg).
  • Received live attenuated vaccines within 1 month before study enrollment;
  • Received inactivated vaccines within 14 days before study enrollment;
  • Received other investigational drugs within 6 months before study enrollment;
  • 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: Double

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: NVSI-06-09 Sequential Immunization Group
the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months
Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) in the deltoid muscle of the upper arm
Active Comparator: Inactivated Vaccine Sequential Immunization Group
the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months
Biological: Inactivated COVID-19 vaccine (Vero cells)
Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

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
GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Time Frame: 14 days after sequential immunization of one booster dose
14 days after sequential immunization of one booster dose
the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Time Frame: 14 days after a single dose of the booster vaccine
14 days after a single dose of the booster vaccine
The incidence rate of any adverse reactions/events
Time Frame: within 30 minutes after vaccination
within 30 minutes after vaccination
The incidence severity of any adverse reactions/events
Time Frame: within 30 minutes after vaccination
within 30 minutes after vaccination
The incidence rate of solicited adverse reactions/events
Time Frame: within 0-7 days after vaccination
within 0-7 days after vaccination
The incidence severity of solicited adverse reactions/events
Time Frame: within 0-7 days after vaccination
within 0-7 days after vaccination
The incidence rate of solicited adverse reactions/events
Time Frame: within 8-30 days after vaccination
within 8-30 days after vaccination
The incidence severity of solicited adverse reactions/events
Time Frame: within 8-30 days after immunization
within 8-30 days after immunization
The incidence of SAE observed
Time Frame: up to 12 months after full course of immunization
up to 12 months after full course of immunization
The incidence of AESI observed
Time Frame: up to 12 months after full course of immunization
up to 12 months after full course of immunization

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
4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Time Frame: 28 days after sequential immunization of one booster dose
28 days after sequential immunization of one booster dose
GMT of anti-omicron neutralizing antibody in adults ≥18 years of age
Time Frame: 28 days after sequential immunization of one booster dose
28 days after sequential immunization of one booster dose
4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Time Frame: 28 days after sequential immunization of one booster dose
28 days after sequential immunization of one booster dose
GMT of anti-omicron IgG antibody in adults ≥18 years of age
Time Frame: before booster vaccination and 28 days after a single dose of the booster vaccine
before booster vaccination and 28 days after a single dose of the booster vaccine
4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age
Time Frame: before booster vaccination and 28 days after a single dose of the booster vaccine
before booster vaccination and 28 days after a single dose of the booster vaccine
proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age
Time Frame: before booster vaccination and 28 days after a single dose of the booster vaccine
before booster vaccination and 28 days after a single dose of the booster vaccine
GMI of anti-omicron IgG antibody in adults ≥18 years of age
Time Frame: before booster vaccination and 28 days after a single dose of the booster vaccine
before booster vaccination and 28 days after a single dose of the booster vaccine
GMTs of anti-omicron neutralizing antibody
Time Frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
3 months, 6 months, 9 months and 12 months after sequential immunization
IgG antibody of anti-omicron neutralizing antibody
Time Frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
3 months, 6 months, 9 months and 12 months after sequential immunization
the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64
Time Frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
3 months, 6 months, 9 months and 12 months after sequential immunization

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 efficacy of recombinant COVID-19 vaccine (CHO cell, NVSI-06-09) against COVID-19, severe cases and deaths after 14 days following sequential immunization in adults ≥18 years of age
Time Frame: During the study，an average of one and a half years
During the study，an average of one and a half years
Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age
Time Frame: 14 days after a single dose of the booster vaccine
14 days after a single dose of the booster vaccine
Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age
Time Frame: 28 days after a single dose of the booster vaccine
28 days after a single dose of the booster vaccine

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.
National Vaccine and Serum Institute, China

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.
China National Biotec Group Company Limited
Beijing Institute of Biological Products Co Ltd.
Lanzhou Institute of Biological Products Co., Ltd

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 25, 2022

Primary Completion (Anticipated)

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.
May 1, 2023

Study Completion (Anticipated)

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.
August 1, 2023

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).
March 22, 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.
March 22, 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.
March 24, 2022

Study Record Updates

Last Update Posted (Actual)

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.
May 31, 2022

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.
May 26, 2022

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, 2022

More Information

Terms related to this study

Keywords

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-REC-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

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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