A Phase 1, Open-label, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults Aged at 19 to 55 Years

HK inno.N Corporation3 个研究点分布在 1 个国家目标入组 40 人开始时间: 2021年9月16日最近更新: 2021年11月9日

适应症

试验速览

阶段: 1 期
发起方: HK inno.N Corporation
入组人数: 40
试验地点: 3
主要终点: Occurrence rate of solicited local and systemic AE

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

This is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults.

详细描述

Total of 40 participants will be enrolled in 3 institutions : Seoul National University Hospital, Jeonbuk National University Hospital, and Chungbuk National University Hospital.

Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Prevention
盲法: None

入排标准

年龄范围: 19 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female participants between the ages of 18 and 55 years.
•Participants considered 'healthy' to be eligible for study participation.
•Participants who are willing and able to comply with all scheduled visits and other study procedures.
•Participants with Body mass index (BMI) within the normal range.
•Participants with deltoid muscle capable of IP injection.
•Those that agreed to using medically approved contraception.
•Female participants with potential pregnancy- Those that used medically approved contraception and has negative result at the pregnancy test.
•Capable of giving personal signed informed consent

排除标准

•Clinically significant symptoms prior to IP injection.
•Confirmed to be COVID-19 RT-PCR positive or to have made close contact with SARS-CoV-2 infected patient.
•History of virologically-confirmed SARS, MERS, or COVID-
•History of congenital or acquired immunodeficiency or autoimmune diseases.
•Positive result of hepatitis B, C, RPR test, or HIV.
•History of disorder that inhibits intramuscular injection of the vaccine.
•History of hypersensitivity and severe allergic reaction to any of the components of IP.
•History of malignant tumor within 5 years prior to the first IP injection.
•Clinically significant chronic diseases that could cause safety concerns regarding COVID-
•Scheduled of , or history of surgery under general anaesthesia prior to first IP injection,
•Female participant that is pregnant or is currently breastfeeding.
•Smoker or history of smoking within 12 weeks prior to first IP injection.
•Previous vaccination or treatment for prevention of COVID-
•Vaccination prior to the first IP injection or scheduled of vaccination after second IP injection.
•Treated with immunoglobulin and/or blood/blood components prior to first IP injection.
•Chronic use of immunosuppressant prior to first IP injection.
•Participated in other clinical study prior to first IP injection, or scheduled to participate in other study during the study period.
•Healthcare worker or emergency response personnel.
•Conditions that may influence the evaluation of the study objectives.

结局指标