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SARS-CoV-2 Acute Respiratory DiseaseCOVID-19NCT04944381

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

A study testing SARS-Cov-2 mRNA vaccine immunization and Inactivated SARS-Cov-2 vaccine immunization in people with SARS-CoV-2 Acute Respiratory Disease, run by Qihan Li.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Acute Respiratory Disease
What is being tested?
SARS-Cov-2 mRNA vaccine immunization and Inactivated SARS-Cov-2 vaccine immunization
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
No sites listed yet
Study dates
2 Jul 2021to 2 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years and above (including boundary values), both female and male.
  • Legal identification of the participants shall be provided.
  • the participants have inoculation two doses of inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS at least 6 months ago.
  • 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.
  • Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
  • Participants with oral temperature ≤ 37.9 ℃.
  • 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).

Who cannot join

  • Contraindications to commonly used vaccines;
  • History of allergy to any vaccines or drug;
  • Received any vaccine within 1 month before the vaccination；
  • 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;
  • 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;
  • Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease；
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  • Surgical removal of whole or part of spleen for any reason；
  • 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);
  • 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;
  • 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.
  • 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;
  • 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;
  • History of COVID-19;
  • 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;
  • Participants who are considered as inappropriate for the trial by investigators.
  • Suspected or known current alcohol or drug dependency.

About this study

Official title: 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.

Read the 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.

Being tested
SARS-Cov-2 mRNA vaccine immunization, Inactivated SARS-Cov-2 vaccine immunization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-Cov-2 mRNA vaccine immunizationBiological

    The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd and .

  • Inactivated SARS-Cov-2 vaccine immunizationBiological

    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).

Study groups in NCT04944381
Study groupRoleWhat they receive
SARS-Cov-2 mRNA vaccine immunization groupExperimentalThe 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd.
Receives: Biological: SARS-Cov-2 mRNA vaccine immunization
Inactivated SARS-Cov-2 vaccine immunization groupExperimentalThe 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS).
Receives: Biological: Inactivated SARS-Cov-2 vaccine immunization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the geometric mean titer (GMT) of neutralizing antibody

    the geometric mean titer (GMT) of neutralizing antibody against SARS-Cov-2 14 days and 28 days after vaccine inoculation

    Measured: 14 days and 28 days

  2. the incident of solicited adverse events(AEs)

    the incident of solicited AEs at the inoculation (local) and solicited AEs at the non-inoculation (systemic) within 7 days after immunization.

    Measured: 7 days

Secondary outcomes (4)

  1. The Geometric Mean Titer (GMT) of IgG antibody

    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

    Measured: 14 days and 28 days

  2. Specific T cells with ELISPOT assay

    Detecting specific T cells with ELISPOT assay 28 days after vaccine inoculation

    Measured: 28 days

  3. The incidence of AEs

    The incidence of AEs from the inoculation to 28 days after the immunization.

    Measured: 28 days

  4. The incidence of SAEs

    The incidence of AEs from the inoculation to at least 12 months after the immunization.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start2 Jul 2021 (estimated)
  3. Primary completion2 Aug 2021 (estimated)
  4. Study completion2 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944381
Sponsor's protocol ID
20210624
Acronym
COVID-19
Status last verified
Jun 2021
First submitted
24 Jun 2021
Last updated
29 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SARS-Cov-2 mRNA vaccine immunization and Inactivated SARS-Cov-2 vaccine immunization in people with SARS-CoV-2 Acute Respiratory Disease, run by Qihan Li.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the geometric mean titer (GMT) of neutralizing antibody (time frame: 14 days and 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.

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