> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-study-of-sars-cov-2-variant-mrna-vaccine-in-healthy-0611bafb-6a91-49af-831b-24d93040eb72 > Record changed: 2026-10-13 # Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants NCT05599802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) Lead sponsor AIM Vaccine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) Start date 2023-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Title and summary **Summary** An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Short title** Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Official title** An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) in Healthy Participants Aged 18 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Dates **Completion date** 2024-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **First posted** 2022-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Registry last updated** 2022-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Primary completion date** 2023-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Start date** 2023-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Lead sponsor** AIM Vaccine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Identifiers **Registry ID** NCT05599802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **ClinicalTrials.gov ID** NCT05599802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Outcomes ### Primary outcomes 1. Incidence, severity, and duration of each solicited (local and systemic) AE. Timeframe: Within 30 minutes and 7 days after (each dose of) vaccination 2. Incidence, severity, and duration of each unsolicited AE. Timeframe: Within 28 days after (each dose of) vaccination 3. The percentage of participants with abnormal hematology and chemistry laboratory values. Timeframe: 4 days after (each dose of) vaccination ### Secondary outcomes 1. Geometric Mean Titer (GMT) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay). Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination 2. Seroconversion Rate (SCR) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay). Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination 3. Geometric Mean Increase (GMI) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay). Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination 4. GMT of S-protein specific IgG antibodies (ELISA) Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination 5. SCR of S-protein specific IgG antibodies (ELISA) Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination 6. GMI of S-protein specific IgG antibodies (ELISA) Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination 7. The incidence, severity, and causality of Serious Adverse Events (SAEs) Timeframe: Within 12 months after (full) vaccination 8. The incidence, severity, and causality of Adverse Events of Special Interest (AESI) Timeframe: Within 12 months after (full) vaccination 9. The incidence, severity, and causality of the occurrence of pregnancy events Timeframe: Within 12 months after (full) vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria - Adults aged 18 years and older. - Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed). - Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. - Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners prior to the (1st dose of) vaccination and must agree to continue such precautions during the study until 3 months after (full) vaccination.\[Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices(IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.\]. - For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before (each dose of) vaccination in this study. - On the day of vaccination and 24 hours prior to (each dose of) vaccination, axillary temperatures<37.3℃/99.1°F. - Healthy participants or participants with mild underlying disease \[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\]. - (For group 2 and group 3 only) Participants who have received full primary vaccination of licensed SARS-CoV-2 vaccine (3-8 weeks between 2 doses of COVID-19 inactivated vaccine or 2 doses of COVID-19 mRNA vaccine) and whose last dose was given >6 mony - (For group 1 only) Not have received any COVID-19 vaccine prior to enrollment. ### Exclusion criteria - Any screening hematology and/or blood biochemistry laboratory value that meets the definition of a ≥Grade 1 abnormality, - (For group 1 only) Confirmed SARS-CoV-2 diagnosis within 1 years before screening visit. - History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections. - Receipt of medications intended to treat COVID-19 with 1 year. - History of server adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s). - SARS-CoV-2 RT-PCR positive nasopharyngeal/oropharyngeal swab specimens at screening. - Positive HIV test at screening. - A history or family history of convulsions, epilepsy, encephalopathy and psychosis. - Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period. - Asplenia of functional asplenia, complete or partial splenectomy from any cause. - Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids are permitted. - Any other licensed vaccines given within 28 days prior to the investigational vaccination, or planned administration of vaccine(s) within 28 days after (full) vaccination. - Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, form 60 days before vaccine administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before vaccine administration, or planned receipt throughout the study. - Blood donation or blood loss ≥450ml within 1 month prior to enrollment or planned to donate blood during the study period. - Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study. - Women who are pregnant or breastfeeding. - Participants deemed unsuitable for participation in this study based on the investigator's assessment. - (For group 1 only: Criteria for delay of 2nd dose of vaccination) Fever within 24 hours prior to the 2nd dose of vaccination (axillary body temperature ≥37.3℃/99.1°F). - (For group 1 only: Criteria for delay of 2nd dose of vaccination) During treatment/recovery from illness. - (For group 1 only: Criteria for delay of 2nd dose of vaccination) Other conditions considered by the investigator to be unsuitable for vaccination. - (For group 1 only: Criteria for termination of 2nd dose of vaccination) Participants with a positive urine pregnancy or blood pregnancy test (women of childbearing age only). - (For group 1 only: Criteria for termination of 2nd dose of vaccination) Serious allergic reactions or serious adverse events related to vaccination (as assessed by the investigator) following a previous dose of vaccine. - (For group 1 only: Criteria for termination of 2nd dose of vaccination) Positive result for SARS-CoV-2 (positive RT-PCR test). - (For group 1 only: Criteria for termination of 2nd dose of vaccination) The investigator considers inappropriate for the participants to continue participation in the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599802) ## Related records ### Drugs (1) - [Adintrevimab](https://trialight.com/data/asset/adintrevimab-54fe54a2-887b-412b-94e4-d15b7c142b42.md) ### Collaborators (2) - LiveRNA Therapeutics Inc. - [Ningbo Rongan Biological Pharmaceutical Co., Ltd.](https://trialight.com/data/company/ningbo-rongan-biological-pharmaceutical-co-ltd-3a28d784-8e5d-4096-876e-f119bc60822c.md) ### Lead sponsors (1) - [AIM Vaccine Co., Ltd.](https://trialight.com/data/company/aim-vaccine-co-ltd-6b3e20ca-fb8c-4c8f-b6cd-86230246697e.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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