Corona Virus Disease 2019(COVID-19)NCT05568693
Sequential Enhanced Safety Study of a Novel Coronavirus Messenger RNA (mRNA) Vaccine in Adults Aged 18 Years and Older.
A study testing 0.3ml of mRNA vaccine in people with Corona Virus Disease 2019(COVID-19), run by Yu Qin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Disease 2019(COVID-19)
- What is being tested?
- 0.3ml of mRNA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2022to 21 Mar 2023
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Corona Virus Disease 2019(COVID-19)
- Being tested
- 0.3ml of mRNA vaccine
- Keywords
- COVID-19, Vaccine, mRNA, Safety, Immunogenicity, >=18 years, 3 doses of Inactivated COVID-19 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3ml of mRNA vaccineBiological
Subjects received 0.3ml of mRNA vaccine intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| mRNA-enhanced immunoem | Experimental | 1 dose of 0.3 ml of mRNA vaccine Receives: Biological: 0.3ml of mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the incidence of adverse reactions (AR) in all subjects within 28 days of exemption
Incidence of adverse reaction (AR)
Measured: 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
Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI)
Measured: 6 months post vaccination
Secondary outcomes (2)
Evaluation of the incidence of adverse reactions in all subjects at 30 minutes post-dispensing
Incidence of adverse reaction (AR)
Measured: 30 minutes post vaccination
Evaluation of the incidence of adverse events in all subjects within 28 days of exemption
Incidence of adverse events (AE)
Measured: 28 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start21 Sep 2022
- Primary completion15 Oct 2022 (estimated)
- Study completion21 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus Disease 2019(COVID-19)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Qin, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568693
- Sponsor's protocol ID
- 2022069
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05568693
- Acronym / sponsor ID
- 2022069
- Conditions
- Corona Virus Disease 2019(COVID-19)
- Keywords
- COVID-19, Vaccine, mRNA, Safety, Immunogenicity, >=18 years, 3 doses of Inactivated COVID-19 vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Yu QinUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 21 Mar 2023 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA-enhanced immunoem | Experimental | Biological: 0.3ml of mRNA vaccine1 dose of 0.3 ml of mRNA vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3ml of mRNA vaccineSubjects received 0.3ml of mRNA vaccine intramuscularly | Biological | mRNA-enhanced immunoem |
Primary outcome
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)
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)
2 secondary outcomes
Evaluation of the incidence of adverse reactions in all subjects at 30 minutes post-dispensing
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.3ml of mRNA vaccine in people with Corona Virus Disease 2019(COVID-19), run by Yu Qin at 1 site in China.
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 4 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of the incidence of adverse reactions (AR) in all subjects within 28 days of exemption (time frame: 28 days post vaccination). 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?
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 6 Oct 2022.