LBCTR2020113522已完成2 期
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers - MERS-201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 542
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures;
- •b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years of age;
- •c. Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening. Note: Participants taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose, as defined by non-change in dose for the 3 months prior to the first dose of study medication and no planned changes during the active dosing period of the study;
- •d. Able and willing to comply with all study procedures;
- •e. Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator;
- •f. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening;
- •g. Screening ECG deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
- •h. Must meet one of the following criteria with respect to reproductive capacity:
- •? Women who are post-menopausal as defined by spontaneous amenorrhea for = 12 months;
- •? Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at least six (6) months prior to enrollment or tubal ligation, absence of ovaries and/or uterus in females);
- •? Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose.
排除标准
- •a.Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose;
- •b.Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing;
- •c.History of respiratory diseases such as asthma, chronic obstructive pulmonary disease or chronic bronchitis;
- •d.Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
- •e.Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;
- •f.Previous receipt of an investigational vaccine product for prevention of MERS;
- •g.Prior exposure to MERS-CoV or camels (serology or antibody testing will be requested at the Investigator’s discretion);
- •h.Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 Part 2;
- •i.Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
- •a.Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site;
- •b.Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a lifethreatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist);
- •c.Any metal implants or implantable medical device within the electroporation site;
- •j.Prisoner or participants who are compulsorily detained (involuntary incarceration);
- •k.Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic corticosteroids must be discontinued at least 3 months prior to first dose;
- •l.Reported active drug or alcohol or substance abuse or dependence.
研究者
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