Sequential Enhanced Safety Study of a Novel Coronavirus Messenger RNA (mRNA) Vaccine in Adults Aged 18 Years and Older.

October 3, 2022 updated by: Yu Qin

Sequential Enhanced Safety Study of a Novel Coronavirus mRNA Vaccine in Adults Aged 18 Years and Older Who Have Completed 3 Doses of a New Inactivated Coronavirus Vaccine.

This trial is a clinical study to evaluate the safety of sequential boosters of novel coronavirus mRNA vaccine in adults aged 18 years and older who have completed three doses of novel inactivated coronavirus vaccination. According to the results of the previous phase I clinical trial, the incidence of adverse reactions in the 0.3 ml dose group was lower than that in the 0.5 ml dose group, and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study, and a 1-dose immunization program was completed for safety observation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.

Detailed Description

According to the results of the preliminary phase I clinical trial, the incidence of adverse reactions in subjects in the 0.3 ml dose group was lower than in the 0.5 ml dose group and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study.

The trial was designed to enroll 800 adult subjects aged 18 years and older who had completed three doses of inactivated New Coronavirus vaccine with an interval of more than 6 months between doses, and the proportion of elderly people aged 60 years and older was approximately 20%. Subjects will receive 0.3 ml of mRNA vaccine, complete a 1-dose immunization program, and undergo safety observations.

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.
800

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.
  • Not Applicable

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

  • China
      • Chengdu, China
        • West China Second University 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old and above adults.
  • Able and willing to comply with the requirements of the clinical trial protocol and able to sign the informed consent form.
  • Willing to discuss medical history with the investigator or physician and allow access to all medical records related to this trial.

Subjects have completed 3 doses of inactivated vaccine with at least 6 months between the last dose.

Exclusion Criteria:

  • Subject is unfit to participate in the study based on the investigator's judgment.
  • History of Middle East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome(SARS) or other coronavirus infection or disease or history of related immunizations.
  • Prior history of severe allergic reactions or hypersensitivity to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, hemangioma, etc., or history of serious adverse reactions associated with vaccines and/or history of severe anaphylactic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
  • Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination, inability to control autoimmune disease, etc.
  • Bleeding constitutional or condition associated with prolonged bleeding, which the investigator believes is contraindicated by intramuscular injection.
  • Positive urine pregnancy test or lactating women, volunteers or their partners who have plans to become pregnant within 6 months.
  • Severe hypertension and uncontrolled by medication (at the time of field measurement: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
  • Suffering from a serious chronic disease or in a progressive stage that cannot be controlled smoothly, such as severe diabetes mellitus, thyroid disease, etc.
  • Previously suffering from serious cardiac diseases such as myocarditis and pericarditis.
  • Those who have planned to receive other vaccines within 28 days before or after the trial vaccination.
  • Those receiving immunosuppressive therapy, including cytotoxic drugs or systemic corticosteroids, such as treatment for cancer or autoimmune disease, or are scheduled to receive treatment throughout the study period. If systemic corticosteroids are used for a short period of time (<14 days) for the treatment of an acute disease, subjects should not be allowed to enter this study until at least 28 days after corticosteroid therapy has ceased prior to study vaccination. Inhalation/spray, intra-articular, intra-bone, or topical (skin or eye) corticosteroid use is permitted.
  • Have received or plan to receive blood/plasma products or immunoglobulins throughout the study period 60 days prior to study inoculation.
  • Participated in other studies involving interventional studies within 28 days prior to study entry and/or during study participation.
  • Have participated in other interventional studies involving lipid-containing nanoparticles.
  • Have suspected COVID-19 symptoms such as respiratory symptoms, fever, cough, shortness of breath, and dyspnea.
  • Axillary temperature >37.0°C or use of over-the-counter medications such as antipyretics and analgesics (e.g. acetaminophen, ibuprofen, naproxen, etc.) within 12 hours prior to experimental vaccination.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: mRNA-enhanced immunoem
1 dose of 0.3 ml of mRNA vaccine
Biological: 0.3ml of mRNA vaccine
Subjects received 0.3ml of mRNA vaccine intramuscularly

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
Measure Description
Time Frame
Evaluation of the incidence of adverse reactions (AR) in all subjects within 28 days of exemption
Time Frame: 28 days post vaccination
Incidence of adverse reaction (AR)
28 days post vaccination
Evaluation of the incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) in all subjects at 6 months after exemption
Time Frame: 6 months post vaccination
Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI)
6 months post vaccination

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
Measure Description
Time Frame
Evaluation of the incidence of adverse reactions in all subjects at 30 minutes post-dispensing
Time Frame: 30 minutes post vaccination
Incidence of adverse reaction (AR)
30 minutes post vaccination
Evaluation of the incidence of adverse events in all subjects within 28 days of exemption
Time Frame: 28 days post vaccination
Incidence of adverse events (AE)
28 days post 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.
Yu Qin

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.
September 21, 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.
October 15, 2022

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.
March 21, 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).
September 30, 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.
October 3, 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.
October 6, 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.
October 6, 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.
October 3, 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.
October 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.
  • 2022069

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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