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| Name | Class |
|---|---|
| Shulan (Hangzhou) Hospital | OTHER |
| Yuncheng Central Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose of LVRNA009 | Biological | 25μg/person |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 28 days after each dose or full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade ≥3 adverse events | 28 days after each dose or full vaccination | |
| Incidence of grade ≥3 adverse events associated with the experimental vaccine | 28 days after each dose or full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Positive conversion rate of anti-2019 novel coronavirus S protein-specific antibody (IgG) (average titer increase ≥4 times compared with baseline) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lanjuan Li | Shulan (Hangzhou) Hospital | Principal Investigator |
| Guiling Chen | Shulan (Hangzhou) Hospital | Principal Investigator |
| Fengli Zhao | Yuncheng Central Hospital | Principal Investigator |
| Jinlian Bi | Xiangya Boai Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Boai Rehabilitation Hospital | Changsha | Hunan | 410329 | China | ||
| Yuncheng Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37925316 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722715 | LVRNA009 COVID-19 vaccine |
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| 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. |
|
| 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. |
|
| Middle-dose of LVRNA009 | Biological | 50μg/person |
|
| High-dose of LVRNA009 | Biological | 100μg/person |
|
| Placebo | Other | 0.5ml/person |
|
| Withdrawal from the trial due to adverse events | 28 days after each dose or full vaccination |
| Incidence of serious adverse event(SAE) | 28 days, 3 months, 6 months and 12 months after primary immunization to full immunization |
| Incidence of SAEs associated with the experiment vaccine | 28 days, 3 months, 6 months and 12 months after primary immunization to full immunization |
| Incidence of clinically significant abnormalities in laboratory tests | 28 days after each dose or full vaccination |
| 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) | 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 | 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) | 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 |
| Yuncheng |
| Shanxi |
| 044099 |
| China |
| Shulan (Hangzhou) Hospital | Hangzhou | Zhejiang | 310022 | China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |