COVID-19Phase 1NCT05364047

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

A Phase 1 study testing Low-dose of LVRNA009, Middle-dose of LVRNA009 and High-dose of LVRNA009 in people with COVID-19, run by AIM Vaccine Co., Ltd. at 3 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Low-dose of LVRNA009, Middle-dose of LVRNA009 and High-dose of LVRNA009
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 3 sitesChina
Study dates: 31 Jul 2021to Oct 2023
Phase: Phase 1
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 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.

Who cannot join

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.;

Show all 20Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

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

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) in Chinese People Aged 18 Years and Over

Conditions: COVID-19
Being tested: Low-dose of LVRNA009, Middle-dose of LVRNA009, High-dose of LVRNA009, Placebo
Medical subject headings: COVID-19

What participants receive

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

Low-dose of LVRNA009Biological
25μg/person
Middle-dose of LVRNA009Biological
50μg/person
High-dose of LVRNA009Biological
100μg/person
PlaceboOther
0.5ml/person

Study groups in NCT05364047
Study group	Role	What they receive
Low-dose group, 18-59 years of age	Other	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. Receives: Biological: Low-dose of LVRNA009; Other: Placebo
Middle-dose group, 18-59 years of age	Other	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. Receives: Biological: Middle-dose of LVRNA009; Other: Placebo
High-dose group, 18-59 years of age	Other	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. Receives: Biological: High-dose of LVRNA009; Other: Placebo
Low-dose group, over 60 years of age	Other	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. Receives: Biological: Low-dose of LVRNA009; Other: Placebo
Middle-dose group, over 60 years of age	Other	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. Receives: Biological: Middle-dose of LVRNA009; Other: Placebo
High-dose group, over 60 years of age	Other	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. Receives: Biological: High-dose of LVRNA009; Other: Placebo

What is being measured

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

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.
Measured: 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.
Measured: 28 days after each dose or full vaccination

Secondary outcomes (6)

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

Timeline

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

31 Jul 2021Oct 2023

First posted6 May 2022
Study start31 Jul 2021
Primary completion14 Oct 2022
Study completionOct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05364047
Sponsor's protocol ID: LVRNA009-I-01
Status last verified: Nov 2022
First submitted: 22 Apr 2022
Last updated: 5 Dec 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chen GL, Yu XY, Luo LP, Zhang F, Dai XH, Li N, Shen ZW, Wu KQ, Lou DF, Peng CG, Jin TH, Huang YM, Shao X, Liu Q, Jiang Q, Guo T, Cao F, Zhu JR, Wu XH, Pei RJ, Deng F, Jiang GP, Li YH, Gao HN, He JX, Zhong-Chen, Peng YC, Li LJ. Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults. Vaccine. 2023 Nov 22;41(48):7297-7306. doi: 10.1016/j.vaccine.2023.10.065. Epub 2023 Nov 3.
PubMed 37925316

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) in Chinese People Aged 18 Years and Over
ClinicalTrials.gov ID: NCT05364047
Acronym / sponsor ID: LVRNA009-I-01
Conditions: COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 144 participants (actual)
Lead sponsor: AIM Vaccine Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Shulan (Hangzhou) Hospital, Yuncheng Central Hospital
Study start: 31 Jul 2021 (actual)
Primary completion: 14 Oct 2022 (actual)
Study completion: Oct 2023 (estimated)
First posted: 6 May 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Low-dose group, 18-59 years of age	Other	Biological: Low-dose of LVRNA009, Other: PlaceboThe 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.
Middle-dose group, 18-59 years of age	Other	Biological: Middle-dose of LVRNA009, Other: PlaceboThe 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.
High-dose group, 18-59 years of age	Other	Biological: High-dose of LVRNA009, Other: PlaceboThe 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.
Low-dose group, over 60 years of age	Other	Biological: Low-dose of LVRNA009, Other: PlaceboThe 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.
Middle-dose group, over 60 years of age	Other	Biological: Middle-dose of LVRNA009, Other: PlaceboThe 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.
High-dose group, over 60 years of age	Other	Biological: High-dose of LVRNA009, Other: PlaceboThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (20 listed)

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;

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
Low-dose of LVRNA00925μg/person	Biological	Low-dose group, 18-59 years of age, Low-dose group, over 60 years of age
Middle-dose of LVRNA00950μg/person	Biological	Middle-dose group, 18-59 years of age, Middle-dose group, over 60 years of age
High-dose of LVRNA009100μg/person	Biological	High-dose group, 18-59 years of age, High-dose group, over 60 years of age
Placebo0.5ml/person	Other	High-dose group, 18-59 years of age, High-dose group, over 60 years of age, Low-dose group, 18-59 years of age, Low-dose group, over 60 years of age, Middle-dose group, 18-59 years of age, Middle-dose group, over 60 years of age

Primary outcome

Incidence of adverse events including solicited adverse event（AE） and unsolicited adverse event（AE）
Time frame: Solicited AE -14 days post-vaccination, all adverse events other than solicited AE - 28 days after vaccination
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.
Incidence of adverse events associated with the experimental vaccine
Time frame: 28 days after each dose or full vaccination
Incidence of adverse events associated with the experimental vaccine within 28 days after each dose or full vaccination.

6 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
Derived from this study: PubMed 37925316Chen GL, Yu XY, Luo LP, Zhang F, Dai XH, Li N, Shen ZW, Wu KQ, Lou DF, Peng CG, Jin TH, Huang YM, Shao X, Liu Q, Jiang Q, Guo T, Cao F, Zhu JR, Wu XH, Pei RJ, Deng F, Jiang GP, Li YH, Gao HN, He JX, Zhong-Chen, Peng YC, Li LJ. Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults. Vaccine. 2023 Nov 22;41(48):7297-7306. doi: 10.1016/j.vaccine.2023.10.065. Epub 2023 Nov 3.

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

Lanjuan Li principal investigator

Shulan (Hangzhou) Hospital

Guiling Chen principal investigator

Shulan (Hangzhou) Hospital

Fengli Zhao principal investigator

Yuncheng Central Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low-dose of LVRNA009, Middle-dose of LVRNA009 and High-dose of LVRNA009 in people with COVID-19, run by AIM Vaccine Co., Ltd. at 3 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 20 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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 adverse events including solicited adverse event（AE） and unsolicited adverse event（AE） (time frame: Solicited AE -14 days post-vaccination, all adverse events other than solicited AE - 28 days after 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 NCT05364047, which also lists 1 linked publication.

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 5 Dec 2022.