Study of Ameliorating Effect of COVID-19 mRNA Vaccine in Individuals Immunized With Inactivated Vaccine (COVID-19)

June 28, 2021 updated by: Qihan Li

a Voluntary, Investigator-initiated, Inactivated COVID-19 Vaccine Controlled Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Above

this is a voluntary, investigator-initiated, inactivated COVID-19 vaccine controlled clinical trial to evaluate the immunogenicity and safety of COVID-19 mRNA vaccine in adults aged 18 years and above which have immunized with two dose of inactivated COVID-19 vaccine at least 6 months ago.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Detailed Description

A total of 112 participants will be enrolled in the study. All the participants have immunized with two doses of inactivated COVID-19 vaccine at least 6 months ago. The 98 participants will be inoculated with one dose COVID-19 messenger ribonucleic acid(mRNA) vaccine from Stemirna Therapeutics Co., Ltd and the others will be inoculated with one dose inactivated COVID-19 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS). Before the inoculation, 14 days and 28 days after the immunization, blood samples will be taken for determination of neutralizing antibody and immunoglobulin G(IgG) antibody against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) N protein and S protein (enzyme-linked immuno sorbent assay, ELISA method); and before the inoculation and 28 days after the immunization, blood samples will be taken for detecting specific T cells with the enzyme-linked immunospot(ELISPOT) assay with an aim to evaluate immunogenicity. Safety observations for all participants will be conducted from the inoculation to 28 days, and follow-up of severe adverse events (SAEs) will also be conducted from inoculation to at least 12 months to evaluate the safety of the investigational vaccine.

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.
112

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

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults aged 18 years and above (including boundary values), both female and male.
  2. Legal identification of the participants shall be provided.
  3. the participants have inoculation two doses of inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS at least 6 months ago.
  4. Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements.
  5. Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
  6. Participants with oral temperature ≤ 37.9 ℃.
  7. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception: a) Condoms (male or female) b) Diaphragm with spermicide c) Cervical cap with spermicide d) Intrauterine device e) Oral or patch contraceptives f) Any country regulatory-approved contraceptive method that is designed to protect against pregnancy g) Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle (other approaches to abstinence are not acceptable).

Exclusion Criteria:

  1. Contraindications to commonly used vaccines;
  2. History of allergy to any vaccines or drug;
  3. Received any vaccine within 1 month before the vaccination；
  4. Serious diseases required to be excluded, including but not limited to history of diseases in nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors;
  5. Before immunizing the investigational vaccine, those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days;
  6. Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease；
  7. Surgical removal of whole or part of spleen for any reason；
  8. Those who have undergone surgery within 3 months before signing the ICF or those who plan to undergo surgery during or within 3 months after completion of the trial (including plastic surgery, dental and oral surgery);
  9. Those who donated or lost blood (≥400 mL) in the past 3 months, who received blood transfusion or use of blood products, or who plan blood donation during the trial;
  10. Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before signing the ICF, or plan to use them during the study.
  11. Those who received immunosuppressant therapy within 6 months before signing the ICF, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs), but local administration is permitted (such as ointment, eye drops, inhalants, or nasal spray). The local administration should not exceed the recommended dose in the package insert or have any signs of systemic exposure;
  12. Participants cannot meet the criteria through the comprehensive physical examination, mainly including: - Abnormal vital signs with clinical significance (awakening heart rate <55 beats/min or >100 beats/min, systolic blood pressure ≥140 millimetre of mercury (mmHg) or diastolic blood pressure ≥90mmHg); - Those who tested positive for type 1 or type 2 human immunodeficiency virus (HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;
  13. History of COVID-19;
  14. Participants who have a positive pregnancy test, or are breastfeeding, or planning pregnancy, or plan to donate sperm or eggs within 12 months from the screening period to the whole-course immunization;
  15. Participants who are considered as inappropriate for the trial by investigators.
  16. Suspected or known current alcohol or drug dependency.

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: Non-Randomized
  • Interventional Model: Parallel 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: SARS-Cov-2 mRNA vaccine immunization group
The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd.
Biological: SARS-Cov-2 mRNA vaccine immunization
The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd and .
Experimental: Inactivated SARS-Cov-2 vaccine immunization group
The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS).
Biological: Inactivated SARS-Cov-2 vaccine immunization
The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS).

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
the geometric mean titer (GMT) of neutralizing antibody
Time Frame: 14 days and 28 days
the geometric mean titer (GMT) of neutralizing antibody against SARS-Cov-2 14 days and 28 days after vaccine inoculation
14 days and 28 days
the incident of solicited adverse events(AEs)
Time Frame: 7 days
the incident of solicited AEs at the inoculation (local) and solicited AEs at the non-inoculation (systemic) within 7 days after immunization.
7 days

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
The Geometric Mean Titer (GMT) of IgG antibody
Time Frame: 14 days and 28 days
The Geometric Mean Titer (GMT) of IgG antibody against SARS-CoV-2 N protein and S protein (ELISA method) 14 days and 28 days after vaccine inoculation
14 days and 28 days
Specific T cells with ELISPOT assay
Time Frame: 28 days
Detecting specific T cells with ELISPOT assay 28 days after vaccine inoculation
28 days
The incidence of AEs
Time Frame: 28 days
The incidence of AEs from the inoculation to 28 days after the immunization.
28 days
The incidence of SAEs
Time Frame: 1 year
The incidence of AEs from the inoculation to at least 12 months after the immunization.
1 year

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.
Qihan Li

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 (Anticipated)

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.
July 2, 2021

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.
August 2, 2021

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 2, 2022

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).
June 24, 2021

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.
June 28, 2021

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.
June 29, 2021

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.
June 29, 2021

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 28, 2021

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.
June 1, 2021

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.
  • 20210624

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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