SARS-CoV-2NCT05745545
Clinical Trial of COVID-19 Vaccine（SARS-CoV-2 Variant(Omicron BA.5) mRNA Vaccine） in Participants Aged 18 Years and Over
A study testing SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine and Saline solution in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine. 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
- What is being tested?
- SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine and Saline solution
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to Nov 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
- Both male and female adults aged 18 and above who can provide identification;
- Know the contents of the informed consent form and the situation of the vaccination, sign the informed consent form voluntarily, and have the ability to use the thermometer, scale and fill in the diary card and contact card as required;
- Ability to communicate well with researchers, understand and comply with the requirements of the study;
- Two or three doses of COVID-19 inactivated vaccine have been completed and ≥6 months have passed since the last dose of COVID-19 inactivated vaccine;
- Healthy subjects or subjects with mild underlying diseases [stable condition with no worsening condition (no need for hospitalization or no major adjustment in treatment regimen, etc.) for at least 3 months prior to inclusion in the study];
- Women who are not possibility to have children (amenorrhea for at least 1 year or surgical sterilization with medical records) or who are known not to be pregnant or lactating and who have used effective contraception for nearly 14 days before vaccination (e.g., Intrauterine or implantable contraceptive devices,oral contraceptives, injected or embedded contraceptives, slow-release topical contraceptives, intrauterine devices (IUD), condoms (male), diaphragm, cervical cap, etc.) (provide negative proof of pregnancy within 48 hours);
- SARS-CoV-2 etiology test (RT-PCR) was negative within 48 hours.
Who cannot join
- Abnormal vital signs that are clinically significant (e.g. abnormal controlled blood pressure);
- Have been infected with COVID-19 or used any COVID-19 prophylactic medication other than 3 doses of COVID-19 inactivated vaccine within the last 6 months (for example, a history of any other non-COVID-19 inactivated vaccine on or off the market, or 1 or 4 doses of COVID-19 inactivated vaccine);
- History of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infection or disease history;
- Axillary temperature ≥37.3℃ or fever within 24 hours on the day of vaccination (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃);
- A history of severe allergic reactions or allergic reactions to vaccines or drugs, such as urticaria, severe eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
- Vaccination of any vaccine within 28 days prior to study vaccination;
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- Enrolled in a clinical study of another drug within 28 days before vaccination or planned to participate in a clinical study of another drug within 6 months after vaccination;
- Have a genetic tendency to bleed or abnormal coagulation function (e.g. cytokine deficiency, coagulation disorder or thrombocytopenia), or a history of severe bleeding;
- A known history or diagnosis of a disease affecting immune system function, such as cancer (other than basal cell carcinoma of the skin), congenital or acquired immunodeficiency (e.g., HIV infection), uncontrolled autoimmune disease, etc.;
- Asplenia or functional asplenia;
- Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulatory drugs (e.g., cortisol: prednisone or similar drugs) within 6 months prior to study vaccination; Interferon, etc.), but topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted, and the dose of topical use shall not exceed that recommended in the instructions;
- Received immunoglobulin and/or blood products within 3 months prior to study vaccination;
- Suspected or known alcohol dependence or drug abuse;
- Other factors considered inappropriate to be included in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui
Huan Zhou
About this study
Official title: A Single-center, Randomized, Blinded, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of One Dose of the SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in People Aged 18 Years and Older Who Had Received Two or Three Doses of Inactivated COVID-19 Vaccine
This is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine.
- Conditions
- SARS-CoV-2
- Being tested
- SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine, Saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccineBiological
One dose was administered by intramuscular injection, 100μg，1.0ml/dose
Saline solutionDrug
One dose was administered by intramuscular injection, 0.5ml/vial
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine | Experimental | Not described Receives: Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person-year incidence of symptomatic COVID-19 of any severity among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Person-year incidence of symptomatic COVID-19 of any severity 14 days after vaccination (≥D14) with a booster dose of study vaccine or placebo among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: 14 days after vaccination or placebo
Secondary outcomes (13)
Person-year incidence of severe and critical COVID-19 in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Person-year incidence of severe and critical COVID-19 after 14 days (≥D14) after booster immunization with 1 dose of study vaccine or placebo in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: 14 days after vaccination or placebo
Person-year incidence of COVID-19 resulting in death in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Person-year incidence of COVID-19 resulting in death 14 days (≥D14) after booster vaccination with 1 dose of study vaccine or placebo in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: 14 days after vaccination or placebo
Person-year incidence of symptomatic COVID-19 of any severity among persons aged 18-59 years and ≥60 years who had received 2 or 3 doses of inactivated COVID-19 vaccine
Person-year incidence of symptomatic COVID-19 of any severity 14 days (≥D14) after booster immunization with 1 dose of study vaccine or placebo among persons aged 18-59 years and ≥60 years who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: 14 days after vaccination or placebo
GMT of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup
In the immunization subgroup, true virus neutralizing antibodies GMT against the current major circulating strain of SARS-CoV-2 were detected 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo
Measured: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
GMI of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup
In the immunization subgroup, true virus neutralizing antibodies GMI against the current major circulating strain of SARS-CoV-2 were detected 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo
Measured: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
SCR of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup
In the immunization subgroup, true virus neutralizing antibodies SCR against the current major circulating strain of SARS-CoV-2 were detected 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo
Measured: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
GMT of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup
GMT of S protein IgG against the current major circulating strain of SARS-CoV-2 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo in the immunization subgroup
Measured: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
GMI of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup
GMI of S protein IgG against the current major circulating strain of SARS-CoV-2 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo in the immunization subgroup
Measured: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
SCR of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup
SCR of S protein IgG against the current major circulating strain of SARS-CoV-2 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo in the immunization subgroup
Measured: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
Incidence of adverse events in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Incidence of adverse events at 30 minutes, 0-14 days and 0-28 days after booster vaccination of 1 dose of study vaccine or placebo in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: 30 minutes, 0-14 days and 0-28 days after vaccination or placebo
Incidence of serious adverse events (SAE) in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Incidence of serious adverse events (SAE) within 6 months after booster immunization with 1 dose of study vaccine or placebo in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: within 6 months after vaccination or placebo
Incidence of AESI in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Incidence of AESI within 6 months after booster immunization with 1 dose of study vaccine or placebo in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: within 6 months after vaccination or placebo
Pregnancy events among persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Pregnancy events within 6 months after booster vaccination with 1 dose of study vaccine or placebo (including: pregnancy outcomes, delivery characteristics, delivery of newborns, and growth and development within 1 month after birth) among persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Measured: within 6 months after vaccination or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start4 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIM Vaccine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University, Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affiliated Hospital of Bengbu Medical UniversityQiang Wu, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745545
- Sponsor's protocol ID
- LVRNA012-IIT-04
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vetter VM, Kurth T, Konigorski S. Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: study protocol of the anti-stress intervention among physicians study. Front Psychiatry. 2024 Aug 23;15:1420097. doi: 10.3389/fpsyt.2024.1420097. eCollection 2024.
PubMed 39247614Emadi Torghabeh A, Aledavood SA, Soltani E, Akbari Oryani M, Akhlaghi S, Hosseini S, Fani Pakdel A, Taghizadeh Kermani A, Anvari K, Shahidsales S, Bahadorian S, Mashreghi Moghaddam S. Pathologic response evaluation of localized or locally advanced esophageal carcinoma to induction chemotherapy followed by preoperative concurrent chemotherapy and hypofractionated radiotherapy: a clinical trial. Front Oncol. 2024 Aug 19;14:1439730. doi: 10.3389/fonc.2024.1439730. eCollection 2024.
PubMed 39224811Zhou H, Zheng H, Peng Y, Su Y, Yu X, Wang W, Li S, Ding Y, Jiao S, Wang Y, Zhu X, Luo L, Dong Z, Liu L, Zhang F, Wu Q, Li J, Zhu F. Efficacy, safety, and immunogenicity of SARS-CoV-2 mRNA vaccine (Omicron BA.5) LVRNA012: a randomized, double-blind, placebo-controlled phase 3 trial. Front Immunol. 2024 Jun 6;15:1407826. doi: 10.3389/fimmu.2024.1407826. eCollection 2024.
PubMed 38903523
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blinded, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of One Dose of the SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in People Aged 18 Years and Older Who Had Received Two or Three Doses of Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05745545
- Acronym / sponsor ID
- LVRNA012-IIT-04
- Conditions
- SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- AIM Vaccine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University, Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 27 Feb 2023 (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 is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine | Experimental | Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine |
| Placebo | Placebo comparator | Drug: Saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both male and female adults aged 18 and above who can provide identification;
- Know the contents of the informed consent form and the situation of the vaccination, sign the informed consent form voluntarily, and have the ability to use the thermometer, scale and fill in the diary card and contact card as required;
- Ability to communicate well with researchers, understand and comply with the requirements of the study;
- Two or three doses of COVID-19 inactivated vaccine have been completed and ≥6 months have passed since the last dose of COVID-19 inactivated vaccine;
- Healthy subjects or subjects with mild underlying diseases [stable condition with no worsening condition (no need for hospitalization or no major adjustment in treatment regimen, etc.) for at least 3 months prior to inclusion in the study];
Key exclusion criteria (14 listed)
- Abnormal vital signs that are clinically significant (e.g. abnormal controlled blood pressure);
- Have been infected with COVID-19 or used any COVID-19 prophylactic medication other than 3 doses of COVID-19 inactivated vaccine within the last 6 months (for example, a history of any other non-COVID-19 inactivated vaccine on or off the market, or 1 or 4 doses of COVID-19 inactivated vaccine);
- History of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infection or disease history;
- Axillary temperature ≥37.3℃ or fever within 24 hours on the day of vaccination (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃);
- A history of severe allergic reactions or allergic reactions to vaccines or drugs, such as urticaria, severe eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
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 |
|---|---|---|
| SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccineOne dose was administered by intramuscular injection, 100μg，1.0ml/dose | Biological | SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine |
| Saline solutionOne dose was administered by intramuscular injection, 0.5ml/vial | Drug | Placebo |
Primary outcome
Person-year incidence of symptomatic COVID-19 of any severity among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: 14 days after vaccination or placebo
Person-year incidence of symptomatic COVID-19 of any severity 14 days after vaccination (≥D14) with a booster dose of study vaccine or placebo among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
13 secondary outcomes
Person-year incidence of severe and critical COVID-19 in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: 14 days after vaccination or placebo
Person-year incidence of COVID-19 resulting in death in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: 14 days after vaccination or placebo
Person-year incidence of symptomatic COVID-19 of any severity among persons aged 18-59 years and ≥60 years who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: 14 days after vaccination or placebo
GMT of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup
Time frame: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
GMI of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup
Time frame: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
SCR of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup
Time frame: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
GMT of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup
Time frame: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
GMI of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup
Time frame: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
SCR of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup
Time frame: 7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo
Incidence of adverse events in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: 30 minutes, 0-14 days and 0-28 days after vaccination or placebo
Incidence of serious adverse events (SAE) in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: within 6 months after vaccination or placebo
Incidence of AESI in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: within 6 months after vaccination or placebo
Pregnancy events among persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine
Time frame: within 6 months after vaccination or placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 39247614Vetter VM, Kurth T, Konigorski S. Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: study protocol of the anti-stress intervention among physicians study. Front Psychiatry. 2024 Aug 23;15:1420097. doi: 10.3389/fpsyt.2024.1420097. eCollection 2024.
- Derived from this study: PubMed 39224811Emadi Torghabeh A, Aledavood SA, Soltani E, Akbari Oryani M, Akhlaghi S, Hosseini S, Fani Pakdel A, Taghizadeh Kermani A, Anvari K, Shahidsales S, Bahadorian S, Mashreghi Moghaddam S. Pathologic response evaluation of localized or locally advanced esophageal carcinoma to induction chemotherapy followed by preoperative concurrent chemotherapy and hypofractionated radiotherapy: a clinical trial. Front Oncol. 2024 Aug 19;14:1439730. doi: 10.3389/fonc.2024.1439730. eCollection 2024.
- Derived from this study: PubMed 38903523Zhou H, Zheng H, Peng Y, Su Y, Yu X, Wang W, Li S, Ding Y, Jiao S, Wang Y, Zhu X, Luo L, Dong Z, Liu L, Zhang F, Wu Q, Li J, Zhu F. Efficacy, safety, and immunogenicity of SARS-CoV-2 mRNA vaccine (Omicron BA.5) LVRNA012: a randomized, double-blind, placebo-controlled phase 3 trial. Front Immunol. 2024 Jun 6;15:1407826. doi: 10.3389/fimmu.2024.1407826. eCollection 2024.
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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.
Huan Zhou principal investigator
The First Affiliated Hospital of Bengbu Medical University
Qiang Wu principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine and Saline solution in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. 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 7 inclusion and 14 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 28 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Contact Huan Zhou (13665527160, zhouhuanbest@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Person-year incidence of symptomatic COVID-19 of any severity among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine (time frame: 14 days after vaccination or placebo). 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 NCT05745545, which also lists 3 linked publications.
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 28 Feb 2023.