NCT05599802尚未招募1 期
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
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Incidence, severity, and duration of each solicited (local and systemic) AE.
研究概览
简要总结
An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1A: 50μg SARS-CoV-2 variant mRNA vaccine
Experimental
Participants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.
干预措施: SARS-CoV-2 variant mRNA vaccine low dose (Biological)
1B: 100μg SARS-CoV-2 variant mRNA vaccine
Experimental
Participants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.
干预措施: SARS-CoV-2 variant mRNA vaccine high dose (Biological)
2A: 50μg SARS-CoV-2 variant mRNA vaccine
Experimental
Participants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.
干预措施: SARS-CoV-2 variant mRNA vaccine low dose (Biological)
2B: 100μg SARS-CoV-2 variant mRNA vaccine
Experimental
Participants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.
干预措施: SARS-CoV-2 variant mRNA vaccine high dose (Biological)
3A: 50μg SARS-CoV-2 variant mRNA vaccine
Experimental
Participants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.
干预措施: SARS-CoV-2 variant mRNA vaccine low dose (Biological)
3B: 100μg SARS-CoV-2 variant mRNA vaccine
Experimental
Participants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.
干预措施: SARS-CoV-2 variant mRNA vaccine high dose (Biological)
结局指标
主要结局
Incidence, severity, and duration of each solicited (local and systemic) AE.
时间窗: Within 30 minutes and 7 days after (each dose of) vaccination
Incidence, severity, and duration of each unsolicited AE.
时间窗: Within 28 days after (each dose of) vaccination
The percentage of participants with abnormal hematology and chemistry laboratory values.
时间窗: 4 days after (each dose of) vaccination
次要结局
- Seroconversion Rate (SCR) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).(Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination)
- Geometric Mean Increase (GMI) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).(Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination)
- SCR of S-protein specific IgG antibodies (ELISA)(Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination)
- The incidence, severity, and causality of Adverse Events of Special Interest (AESI)(Within 12 months after (full) vaccination)
- GMT of S-protein specific IgG antibodies (ELISA)(Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination)
- GMI of S-protein specific IgG antibodies (ELISA)(Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination)
- The incidence, severity, and causality of Serious Adverse Events (SAEs)(Within 12 months after (full) vaccination)
- Geometric Mean Titer (GMT) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).(Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination)
- The incidence, severity, and causality of the occurrence of pregnancy events(Within 12 months after (full) vaccination)
研究者
相似试验
已完成
1 期
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy AdultsHIVNCT05470400National Institute of Allergy and Infectious Diseases (NIAID)44
已完成
1 期
MEDI5752 in Japanese Patients With Advanced Solid Tumors.Advanced Solid TumorsNCT05685472AstraZeneca6
Unknown
1 期
To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy AdultsCoronavirus Disease (COVID-19)NCT04885361OSE Immunotherapeutics48
终止
1 期
VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M VaccineMalaria,FalciparumNCT04130282University of Oxford1
已完成
1 期
Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast CancerMetastatic Breast CancerNCT00952692Michael Morse, MD12