Status unknownNCT05364047Updated Dec 5, 2022

Clinical Trial of SARS-CoV-2 mRNA Vaccine in China

A Phase 1 interventional study of Low-dose of LVRNA009 and Middle-dose of LVRNA009 in COVID-19, sponsored by AIM Vaccine Co., Ltd.. Status unknown at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by AIM Vaccine Co., Ltd. · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

Registered 8 months after the study started (first participant enrolled Jul 2021, registered Apr 2022).

Phase: Phase 1
Study type: Interventional
Enrollment: 144
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study is a phase I clinical trial. The investigators intent to evaluate the safety, tolerability and preliminary immunogenicity of SARS-CoV-2 mRNA vaccine (LVRNA009) in Chinese people aged 18 years and over.

Conditions studied

COVID-19

In context

Lead sponsor

AIM Vaccine Co., Ltd. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age at the time of the first dose of vaccine: aged 18 to 59 years (including boundary values) in the adult group, >=60 years old in the older group, regardless of gender;
Axillary body temperature is less than 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.

Exclusion criteria

Exclusion Criteria:

The subject has a history of SARS-CoV-2 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;
Anyone who is allergic to any vaccines, drugs, foods or known excipients (Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG);
Have a history of SARS virus infection;
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 or 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);
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;
There is evidence that they are smokers (smokers >=10 cigarettes/day), alcoholics (alcohol consumption >=4 units/day), drug abusers, and those who do not agree to quit smoking or drinking during the trial;
Positive SARS-CoV-2 nucleic acid test and/or positive antibody test before the first dose of vaccine, and/or abnormal imaging examination (small patchy shadow and interstitial change, obvious peripheral lung zone, ground-glass shadow, infiltrating shadow, lung consolidation, etc.), and/or decreased lymphocyte count;
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.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 144 participants (actual)

Study arms

Other
Low-dose group, 18-59 years of age
The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 25μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.
Biological: Low-dose of LVRNA009 · Other: Placebo
Other
Middle-dose group, 18-59 years of age
The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 50μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.
Biological: Middle-dose of LVRNA009 · Other: Placebo
Other
High-dose group, 18-59 years of age
The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 100μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.
Biological: High-dose of LVRNA009 · Other: Placebo
Other
Low-dose group, over 60 years of age
The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 25μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.
Biological: Low-dose of LVRNA009 · Other: Placebo
Other
Middle-dose group, over 60 years of age
The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 50μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.
Biological: Middle-dose of LVRNA009 · Other: Placebo
Other
High-dose group, over 60 years of age
The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 100μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.
Biological: High-dose of LVRNA009 · Other: Placebo

Interventions

BiologicalLow-dose of LVRNA009
25μg/person
BiologicalMiddle-dose of LVRNA009
50μg/person
BiologicalHigh-dose of LVRNA009
100μg/person
OtherPlacebo
0.5ml/person

What researchers measure

Primary outcomes

Incidence of adverse events including solicited adverse event（AE） and unsolicited adverse event（AE）
Solicited AE--14 days post-vaccination, common reactions at the vaccination site and non-vaccination site pre-listed on the subject's diary card and electronic case report form（eCRF）, including pain, induration, swelling, rash, flushing, itching, cellulitis at injection site, fever, headache, chills, anorexia, diarrhea, nausea, vomiting, fatigue, weakness, arthralgia, acute allergic reaction, muscle pain at non-inoculation site. non-solicited AE --28 days after vaccination, all adverse events other than solicited AE and after 14 days.
Time frame: Solicited AE -14 days post-vaccination, all adverse events other than solicited AE - 28 days after vaccination
Incidence of adverse events associated with the experimental vaccine
Incidence of adverse events associated with the experimental vaccine within 28 days after each dose or full vaccination.
Time frame: 28 days after each dose or full vaccination

Secondary outcomes

Incidence of grade ≥3 adverse events
Time frame: 28 days after each dose or full vaccination
Incidence of grade ≥3 adverse events associated with the experimental vaccine
Time frame: 28 days after each dose or full vaccination
Withdrawal from the trial due to adverse events
Time frame: 28 days after each dose or full vaccination
Incidence of serious adverse event（SAE）
Time frame: 28 days, 3 months, 6 months and 12 months after primary immunization to full immunization
Incidence of SAEs associated with the experiment vaccine
Time frame: 28 days, 3 months, 6 months and 12 months after primary immunization to full immunization
Incidence of clinically significant abnormalities in laboratory tests
Time frame: 28 days after each dose or full vaccination

Other outcomes

Positive conversion rate of anti-2019 novel coronavirus S protein-specific antibody (IgG) (average titer increase ≥4 times compared with baseline)
Time frame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Geometric mean titer (GMT) of anti-2019 novel coronavirus S protein-specific antibody (IgG) and mean fold increase compared with baseline
Time frame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Positive conversion rate of anti-2019 novel coronavirus neutralizing antibody GMT （average titer increase ≥4 times compared with baseline)
Time frame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Geometric mean titer (GMT) of anti-2019 novel coronavirus neutralizing antibody and mean fold increase compared with baseline
Time frame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Level of specific cellular immune response against 2019 novel coronavirus（CD4+、CD8+ and IL-2、IL-4、IL-6、IL-10、IFN-γ and TNF-α）
Time frame: 14 days and 28 days after the first dose, 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination

Study locations

3 sites

Xiangya Boai Rehabilitation Hospital
Changsha, Hunan 410329, China
Yuncheng Central Hospital
Yuncheng, Shanxi 044099, China
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang 310022, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05364047
Lead sponsor: AIM Vaccine Co., Ltd.
Collaborators: Shulan (Hangzhou) Hospital, Yuncheng Central Hospital
Responsible party: Sponsor
First posted: May 6, 2022
Start date: Jul 31, 2021
Primary completion: Oct 14, 2022
Completion: Oct 2023 (estimated)
Last update: Dec 5, 2022

Study contacts

Lanjuan Li

principal investigator · Shulan (Hangzhou) Hospital

Guiling Chen

principal investigator · Shulan (Hangzhou) Hospital

Fengli Zhao

principal investigator · Yuncheng Central Hospital

Jinlian Bi

principal investigator · Xiangya Boai Rehabilitation Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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