NCT04522089已完成1 期
A Randomized, Single Center, Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of Pandemic Virus Vaccine, AdimrSC-2f (SARS-CoV-2), in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The solicited adverse events (SoAEs)
研究概览
简要总结
This study aims to evaluate the safety and immunogenicity of the preventative vaccine, AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old.
详细描述
The objectives of this phase I study are:
- to evaluate the safety profile of the AdimrSC-2f vaccine, and
- to assess the immunogenicity of the AdimrSC-2f vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet ALL inclusion criteria will be included.
- •Male or non-pregnant female, aged 20 to 60 years old (inclusive).
- •Subject who is physically and mentally capable of participating the study and are willing to adhere to study procedures.
- •Subject with no clinically significant abnormal findings in medical history, physical examination, vital signs, or clinical laboratory results at the Screening visit based on the investigator's judgment.
- •Subject with negative test result in SARS-CoV-2 antibody (IgG and IgM) rapid test at the Screening visit.
- •Subject with negative serology test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.
- •Subjects' clinical laboratory test results are in the normal range or with abnormal values without clinical significance as judged by the investigator.
- •Female subject with childbearing potential must have negative result in urine pregnancy test at the Screening visit.
- •Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
- •Intrauterine device plus one barrier method
- •Oral, implantable, or injectable contraceptives plus one barrier method; or
- •Two barrier methods Effective barrier methods are male or female condoms, diaphragms, or spermicides (creams or gels that contain a chemical to kill sperm). Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year.
- •Male subject who agrees to use an adequate method of contraception during the study period [e.g., barrier contraceptives (male condom)].
- •Subject who provides informed consent after receiving a detailed explanation of study procedures.
排除标准
- •Subjects who meet ANY exclusion criteria will be excluded.
- •Subject with a body mass index (BMI) < 18.5 kg/m2 (underweight) or ≥ 35 kg/m2 (greater than Class I obesity) at the Screening Visit.
- •Subject with history of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.
- •Subject has ongoing or medical history of hypertension or diabetes mellitus.
- •Subject has ongoing use of tobacco or nicotine-containing products (nicotine patch included) or e-cigarette devices or with history of using nicotine-containing product as documented in medical chart or by verbal confirmation at screening.
- •Subject with documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months (approximately 180 days) prior to the Screening visit.
- •Subject who received any vaccine (live, inactivated, or bacterial) within 1 month (approximately 30 days) prior to the Screening visit.
- •Subject with hypersensitivity to the ingredients of AdimrSC-2f (including aluminum).
- •Subject with personal or family history of Guillain-Barré Syndrome.
- •Subject who has travelled abroad within 3 months (approximately 90 days) prior to the Screening visit.
- •Subject with influenza-like illness as defined by any of the following symptoms at Screening visit: fever (tympanic temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat.
- •Female subject who is pregnant or lactating at screening or plans to be pregnant during the study period.
- •Subject who treated with an investigational drug or device or have participated in a clinical study within 3 months (approximately 90 days) prior to the Screening visit.
- •Subject with clinically significant abnormal ECG at the Screening visit or with history of clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure, as judged by the investigator.
- •Subject with any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency or received any immunosuppressants or immunomodulators within 6 months (approximately 180 days) prior to the Screening visit.
- •Subject with history of wheezing, asthma, chronic obstructive pulmonary disease, or have used bronchodilator within 3 months (approximately 90 days) prior to the Screening visit.
- •Subject who had blood donation within 2 weeks prior to the Screening visit.
- •Subject who received any blood products, including immunoglobulin within 3 months (approximately 90 days) prior to the Screening visit.
- •Subject who is not suitable to participate in this study as judged by the investigator.
- •Subject with chronic illness.
结局指标
主要结局
The solicited adverse events (SoAEs)
时间窗: The 7 days following each vaccination
Determining the solicited adverse events (SoAEs) (the percentage, severity, and relationship to the AdimrSC-2f vaccine) during 7 days following each vaccination.
Incidence of abnormal laboratory tests results
时间窗: Day 7 after vaccination
Determining the clinically significant changes in hematology, biochemistry, and coagulation results from baseline at Visit 2 and Visit 4.
次要结局
- Safety of AdimrSC-2f vaccine: AE(Day 0 to Day 182)
- Immunogenicity(Day 21 and 42)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and OlderInfluenza, Human PreventionRespiratory Syncytial Viruses PreventionNCT05071313Janssen Vaccines & Prevention B.V.777
已完成
1 期
A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent InfluenzaInfluenzaNCT00706732AlphaVax, Inc.28
已完成
3 期
Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult VolunteersInfluenzaNCT01987011Green Cross Corporation420
撤回
2 期
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or OlderInfluenzaNCT00342940Novartis
已完成
3 期
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A VaccineHepatitis A VaccineNCT03654664Boryung Pharmaceutical Co., Ltd119