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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
144
25μg/person
50μg/person
100μg/person
Xiangya Boai Rehabilitation Hospital
Changsha, Hunan, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
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
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
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0.5ml/person
Incidence of clinically significant abnormalities in laboratory tests
Time frame: 28 days after each dose or full vaccination