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临床试验/NCT05903118
NCT05903118已完成1 期

A Phase I/II, Randomized, Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (RBMRNA-176) in Healthy Adults Aged 18 Years and Older

Argorna Pharmaceuticals Co., LTD1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2022年1月8日最近更新:
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适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
480
试验地点
1
主要终点
Solicited local and systemic adverse reactions (AR)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The phase I/II study is to evaluate the safety and immunogenicity of SARS-COV-2 mRNA Vaccine (RBMRNA-176) at different doses in healthy subjects aged 18 years and older.

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
Double (Participant, Investigator)

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, Body Mass Index (BMI) is between 18-30, able to provide legal proof of identity
  • •Participants voluntarily agreed to participate in the study and signed an informed consent form
  • •The subject has ability to understand the research process and is willing and able to comply with all research proposals and other requirements of the study
  • •Axillary temperature ≤37.3°C on the day of injection
  • •Negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test, without infective history of severe acute respiratory syndrome (SARS), coronavirus disease 2019 (COVID-19), Middle East Respiratory Syndrome (MERS)
  • •Female subjects of childbearing age are not at pregnant period (negative result of pregnancy test) or lactation period
  • •Female subjects of childbearing age had taken effective contraceptive measures 1 month before enrollment
  • •Female subjects of childbearing age and male subjects agree to use effective contraception for 12 months from the screening visit to the full injection
  • •Female subjects of childbearing age and male subjects agree that do not donate eggs (eggs, oocytes) for assisted reproduction (female subjects of childbearing age) or avoid sperm donation (male subjects) from screening period until 12 months after injection

排除标准

  • •Chest x - ray is clinically significant abnormal as determined by the investigators
  • •The vital signs or examinations are clinically significant abnormal as determined by the investigators prior to randomization
  • •A history of severe allergy (including drugs, vaccines, and foods) or to any component of the experimental vaccine, e.g., allergic shock, allergic laryngeal edema, anaphylactoid purpura, dyspnea, and angioedema, etc.
  • •Subjects have been diagnosed with a serious disease, congenital malformation or chronic disease (including but not limited to: respiratory disease or chronic bronchitis such as asthma, serious cardiovascular disease, kidney disease, autoimmune disease, thrombocytopenic purpura, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that may interfere with the conduct or completion of the study
  • •Diagnosed with diseases may affect immune system function, congenital or acquired immune deficiency or suppression (e.g., tuberculosis, human immunodeficiency virus (HIV)), Hepatitis B, hepatitis C, syphilis infection, uncontrollable autoimmune disease, no spleen or spleen dysfunction
  • •Lymph node - related diseases (such as lymphadenitis, lymph node adhesion, lymph node tuberculosis, tumor metastasis, etc.) or skin scars and fistulas at the lymph node site, or lymphadenopathy, tenderness, skin redness and swelling at the lymph node site within 7 days prior to injection
  • •History or family history of convulsions, epilepsy, encephalopathy, psychiatry, or history of narcolepsy
  • •Within 3 days prior to injection, an acute illness or attack of a chronic disease, or the use of antipyretic analgesic or anti - allergic drugs
  • •Subjects have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any blood clotting disorder or receiving anticoagulant therapy
  • •Long-term use of immunopotentiator or immunosuppressant therapy within 6 months prior to the first dose injection (continuous orally or by injection for more than 14 days).
  • •Use of any blood or blood - related products (e.g., blood transfusion, use of human albumin, human immunoglobulin, etc.) within 6 months prior to the first dose injection
  • •Any blood lost > 400 mL within 28 days prior to the screening visit (e.g., donate blood or component blood, or injured), or plan to donate blood or component blood between the screening visit and 28 days after the last dose injection
  • •Previously received any SARS-CoV-2 vaccine or plan to receive other SARS-CoV-2 vaccines
  • •Other vaccines have been administered within 4 weeks prior to the first dose injection or other injection schedule (except for emergency injections such as Rabies vaccine and Tetanus vaccine) between the screening period and 28 days after the injection
  • •Any abnormal or permanent body art (such as tattoos) at the site of the injection, which the researchers think to interfere with observing local reactions at the site of the injection
  • •Female subjects planning to become pregnant or male subjects' partners planning to become pregnant from screening period to 12 months after whole schedule injection
  • •Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study
  • •Other circumstances considered by the investigator as inappropriate to participate in the study

结局指标

主要结局

Solicited local and systemic adverse reactions (AR)

时间窗: Within 14 days after each dose

For phase I

The level of neutralizing antibody against SARS-CoV-2

时间窗: The 28th day after the whole schedule injection

For phase II

All Adverse Events (AE) related to injection

时间窗: From the first dose to within 28 days after the whole schedule injection

For phase I

次要结局

  • The level of neutralizing antibody against SARS-CoV-2(The 21st day after the first dose, and the 7th day, 90th day, 180th day, 360th day after the whole schedule injection)
  • Unsolicited Adverse Events (AE)(After the first dose till before the second dose, and within 28 days after the second dose)
  • The level of Immunoglobulin G (IgG) antibody against SARS-CoV-2 S protein(The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection)
  • All AEs related to injection(From the first dose to within 28 days after the whole schedule injection)
  • All serious adverse events (SAE)(Within 21 days after the first dose, and within 28 days after the second dose, and 90days, 180 days, 360 days after the whole schedule injection)
  • Solicited local and systemic ARs(Within 14 days after each dose)

研究者

发起方
Argorna Pharmaceuticals Co., LTD
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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