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SARS-CoV-2NCT05550142

A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China

A study testing SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Low dose and SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 preliminary exploratory cohort study to evaluate safety, tolerability and immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in participants aged 18 years and over in China. 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 Low dose and SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteChina
Study dates
16 Sep 2022to Mar 2024
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

  • Age at the time of first dose of vaccine: adults aged 18-59 years (including boundary values), elderly ≥60 years, both sexes;
  • Armpit temperature <37.3℃ on the day of enrollment;
  • Based on the medical history and relevant physical examination and laboratory examination results, the investigator clinically determined that the patient was in good health;
  • Subjects have independent judgment ability, can read, understand and complete vaccination diary cards, and they participate voluntarily and sign an informed consent form.

Who cannot join

  • The subject has a history of SARS-CoV-2 or SARS infection, or has a history of contact with SARS-CoV-2 infected persons (nucleic acid test positive) or suspected infected persons within 30 days before screening, or living abroad within 30 days before screening history, or a positive SARS-CoV-2 nucleic acid test or a positive SARS-CoV-2 IgM or IgG test before the first dose of vaccine;
  • History of allergy to any component of the study vaccine or a history of a severe allergic reaction to the vaccine or drug (including but not limited to anaphylactic shock, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, or local anaphylactic necrosis [Arthus reaction]);
  • Upon questioning, have a history of COVID-19 vaccination, or have received other inactivated vaccines within 14 days before screening, and received live attenuated vaccines within 28 days;
  • Patients have a medical history or family history of epilepsy, convulsions, neurological diseases and mental diseases;
  • There are contraindications for intramuscular injection, such as: thrombocytopenia that has been diagnosed, any coagulation disorder or receiving anticoagulant treatment, etc.;
  • The investigator judges that he is known or suspected of having more serious diseases at the same time, including but not limited to: respiratory diseases (tuberculosis, lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), Malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided), or during the active period of acute infection or chronic disease (within 3 days before vaccination);
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  • Congenital malformations, developmental disorders, or chronic diseases that the investigator judges are not suitable for participating in this study (such as Downs syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc.), excluding stable diabetes/hypertension );
  • Patients with known immunological impairment or low immunological function diagnosed by the hospital before enrollment, or functional asplenia or splenectomy caused by any situation;
  • Those with evidence of tobacco, alcohol, and drug abuse, and those who did not agree to abstain from smoking and drinking during the study period;
  • During the screening period, laboratory tests (blood routine, urine routine, blood biochemistry, troponin, coagulation routine, D-dimer) and electrocardiogram abnormalities were clinically significant;
  • Female: those who have a positive blood pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan within one year; men: whose spouse has a pregnancy plan within one year;
  • Patients have participated in other clinical trials (drugs, biological products or devices) within 3 months before the first dose of vaccine, or plan to participate in other clinical trials during the research period;
  • Patients received immune enhancement or immunosuppressive therapy within 6 months before the first dose of vaccine (continuous oral or instillation for more than 14 days);
  • Patients donated blood ≥400 ml within 28 days before screening, or received whole blood, plasma and immunoglobulin therapy within 6 months before screening;
  • Currently receiving research drug treatment to prevent COVID-19;
  • Patients are taking antipyretic, analgesic and anti-allergic drugs within 3 days before enrollment;
  • The investigator judges that the subjects cannot follow the research procedures, comply with the agreement, or plan to permanently relocate from the area before the end of the research, or plan to leave the local area for a long time during the scheduled visit period;
  • The relevant staff involved in this study or their immediate family members (such as spouses, parents, siblings or children);
  • According to the investigator's judgment, there are other situations that are not suitable for participating in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital Bengbu Medical College

    Bengbu, Anhui

Other trials in China

About this study

Official title: A Preliminary Exploratory Cohort Study to Evaluate Safety, Tolerability and Immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in Participants Aged 18 Years and Over in China

This is a preliminary exploratory cohort study to evaluate safety, tolerability and immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in participants aged 18 years and over in China.

Conditions
SARS-CoV-2
Being tested
SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Low dose, SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose, Placebo

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 vaccine Low doseBiological

    50μg/dose

  • SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High doseBiological

    100μg/dose

  • PlaceboDrug

    Saline solution

Study groups in NCT05550142
Study groupRoleWhat they receive
SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 50μgExperimentalTwo doses were administered by intramuscular injection, 28 days apart
Receives: Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Low dose; Drug: Placebo
SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 100μgExperimentalTwo doses were administered by intramuscular injection, 28 days apart
Receives: Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose; Drug: Placebo

What is being measured

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

  1. Incidence of solicited adverse events

    Measured: Within 28 days after each dose/full dose

  2. Incidence of unsolicited adverse events

    Measured: Within 28 days after each dose/full dose

  3. Incidence of adverse events associated with the study vaccine

    Measured: Within 28 days after each dose/full dose

Secondary outcomes (8)

  1. Incidence of grade ≥3 adverse events

    Adverse events were graded from pain, tenderness, itching, induration, swelling and other aspects, and the higher the grade, the more serious the adverse events were

    Measured: Within 28 days after each dose/full dose

  2. Incidence of grade ≥3 adverse events associated with the study vaccine

    Adverse events were graded from pain, tenderness, itching, induration, swelling and other aspects, and the higher the grade, the more serious the adverse events were

    Measured: Within 28 days after each dose/full dose

  3. Statistics of withdrawal from the study due to adverse events

    Measured: Within 28 days after each dose/full dose

  4. Incidence of SAE

    Measured: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

  5. Incidence of AESI

    Measured: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

  6. Incidence of SAE associated with the study vaccine

    Measured: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

  7. Incidence of AESI associated with the study vaccine

    Measured: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

  8. Incidence of clinically significant abnormalities in laboratory measures

    Measured: Through study completion, an average of 12 months

Timeline

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

  1. First posted22 Sep 2022
  2. Study start16 Sep 2022
  3. Primary completion19 Dec 2022
  4. Study completionMar 2024 (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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05550142
Sponsor's protocol ID
LVRNA012-IIT-02
Status last verified
Sep 2022
First submitted
18 Sep 2022
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Low dose and SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose 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 4 inclusion and 19 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 14 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. 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?

Incidence of solicited adverse events (time frame: Within 28 days after each dose/full dose). The study lists 3 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 NCT05550142.

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 14 Feb 2023.

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