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SARS-CoV-2Phase 2NCT05352867

Clinical Trial of SARS-CoV-2 mRNA Vaccine in Chinese People

A Phase 2 study testing SARS-CoV-2 (LVRNA009) 50μg group and SARS-CoV-2 (LVRNA009) 100μg group in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of the New Coronavirus mRNA Vaccine (LVRNA009) in Chinese People Aged 18~59 Years Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
SARS-CoV-2 (LVRNA009) 50μg group and SARS-CoV-2 (LVRNA009) 100μg group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
2 sitesChina
Study dates
16 Mar 2022to 21 Jun 2023
Phase
Phase 2
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 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The age at the time of the first dose of the vaccine is 18-59 years old, and the gender is not limited;
  • The subject has full capacity for civil conduct;
  • Axillary body temperature is less than 37.3 ℃ on the day of enrollment;
  • 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 contact with a person infected with SARS-CoV-2 (positive nucleic acid test) or a person suspected of being infected within 14 days;
  • Have a history of severe allergies to any vaccines, foods, and drugs, such as urticaria, anaphylactic shock, skin eczema, allergic dyspnea, angioedema, etc.;
  • The subject has a history of hypersensitivity to any component of the study vaccine (SARS-CoV-2 mRNA, Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG, phosphate buffer);
  • Have a history of SARS virus infection;
  • Those with a medical history or family history of epileptic convulsions or convulsions, neurological diseases and mental diseases;
  • There is a history of thrombocytopenia or other coagulation disorders diagnosed by the hospital before enrollment;
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  • The investigator judges that they are known or suspected to suffer from more serious diseases at the same time, including: respiratory diseases, tuberculosis, acute infection or active chronic disease, liver and kidney disease, cardiovascular disease (cardiopulmonary failure), and drug-uncontrollable hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg), malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided);
  • Congenital malformations, developmental disorders, or chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain-Barré syndrome) determined by the investigator to be unsuitable for participating in this research;
  • Those with known immunological impairment or low function diagnosed by the hospital before enrollment;
  • There is evidence that he is a smoker, alcohol abuser and drug abuser;
  • Positive SARS-CoV-2 nucleic acid test results and/or positive antibody test results before the first dose of vaccination;
  • Female: a person with a positive urine pregnancy test, who is pregnant, breastfeeding, or has a pregnancy plan within 1 year; male: a person whose spouse has a pregnancy plan within 1 year;
  • Any other investigational or unregistered product (drug, biological product, or device) is being used before the first dose of vaccine, or is planned to be used during the study;
  • Those who received immune enhancement or immunosuppressive therapy within 6 months before the first dose of vaccine (continuous oral or infusion for more than 14 days);
  • Has been diagnosed with congenital or acquired immunodeficiency, or suspected of having a systemic disease that may interfere with the conduct or completion of the study, such as: tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV); ), syphilis infection, etc.;
  • Those who have received whole blood, plasma and immune globulin treatment within 6 months before the first dose of vaccine;
  • Received other inactivated vaccines within 14 days before the first dose of vaccine, and received live attenuated vaccines within 28 days;
  • Antipyretic, analgesic and anti-allergic drugs are being used within 3 days before enrollment;
  • Subjects who, in the judgment of the investigator, cannot follow the research procedures, abide by the agreement, or plan to permanently relocate from the local area before the end of the study, or plan to leave the local area for a long time during the scheduled visit;
  • The relevant staff members involved in this research or their immediate family members (such as spouses, parents, siblings or children);
  • According to the judgment of the investigator, there are other circumstances that are not suitable for participating in this clinical trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Outpatient Department of Hunan Provincial Center For Disease Control And Prevention

    Changsha, Hunan, 410028

  • Xiangtan Center For Disease Control And Prevention

    Xiangtan, Hunan, 411228

Other trials in China

About this study

Official title: Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) in Chinese People Aged 18~59 Years

Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of the New Coronavirus mRNA Vaccine (LVRNA009) in Chinese People Aged 18~59 Years

Conditions
SARS-CoV-2
Being tested
SARS-CoV-2 (LVRNA009) 50μg group, SARS-CoV-2 (LVRNA009) 100μg group, Placebo

What participants receive

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

  • SARS-CoV-2 (LVRNA009) 50μg groupBiological

    50μg/person

  • SARS-CoV-2 (LVRNA009) 100μg groupBiological

    100μg/person

  • PlaceboOther

    0.5ml/person

Study groups in NCT05352867
Study groupRoleWhat they receive
50μg groupExperimentalNot described
Receives: Biological: SARS-CoV-2 (LVRNA009) 50μg group
100μg groupExperimentalNot described
Receives: Biological: SARS-CoV-2 (LVRNA009) 100μg group
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Level of SARS-CoV-2 novel coronavirus S protein antibody (IgG)

    Measured: 28 days after full-vaccination

  2. Level of SARS-CoV-2 novel coronavirus neutralizing antibodies

    Measured: 28 days after full-vaccination

Secondary outcomes (12)

  1. Incidence of adverse events

    Measured: 14 days and 28 days after each dose of vaccination

  2. Incidence of adverse events associated with the experimental vaccine

    Measured: 14 days and 28 days after each dose of vaccination

  3. Incidence of SAEs

    Measured: 28 days, 3 months, 6 months and 12 months after first vaccination to full vaccination

  4. Incidence of SAEs associated with the experimental vaccine

    Measured: 28 days, 3 months, 6 months and 12 months after first vaccination to full vaccination

  5. Incidence of grade ≥3 adverse events

    Measured: 28 days after each dose or full vaccination

  6. Incidence of grade ≥3 adverse events associated with the experimental vaccine

    Measured: 28 days after each dose or full vaccination

  7. Withdrawal from the trial due to adverse events

    Measured: 28 days after each dose or full vaccination

  8. Level of SARS-CoV-2 novel coronavirus S protein antibody (IgG)

    Measured: 14 days, 3 months, 6 months and 12 months after full vaccination

  9. Positive conversion rate of SARS-CoV-2 novel coronavirus S protein antibody

    Measured: 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination

  10. Level of SARS-CoV-2 novel coronavirus neutralizing antibody

    Measured: 14 days, 3 months, 6 months and 12 months after full vaccination

  11. Positive conversion rate of SARS-CoV-2 novel coronavirus neutralizing antibody

    Measured: 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination

  12. Level of specific cellular immune response against the new coronavirus (2019-nCoV) in subjects participating in cellular immune blood collection（IL-2、IL-4、IL-13、IFN-γ ）（ELISPOT）

    Measured: 7th day after full vaccination

Timeline

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

  1. First posted29 Apr 2022
  2. Study start16 Mar 2022
  3. Primary completion23 Jun 2022
  4. Study completion21 Jun 2023

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352867
Sponsor's protocol ID
LVRNA009-Ⅱ-01
Status last verified
Sep 2023
First submitted
25 Apr 2022
Last updated
6 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SARS-CoV-2 (LVRNA009) 50μg group and SARS-CoV-2 (LVRNA009) 100μg group in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 2 sites 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 21 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: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Level of SARS-CoV-2 novel coronavirus S protein antibody (IgG) (time frame: 28 days after full-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?

On the ClinicalTrials.gov record for NCT05352867.

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 Sep 2023.

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