Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 6
- 主要终点
- Frequency of Adverse Events in Part 2
研究概览
简要总结
The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study was divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
- •Able and willing to comply with all study procedures;
- •Screening laboratory results within normal limits;
- •Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
- •Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
- •Be post-menopausal or be surgically sterile or have a partner who is sterile or use 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
- •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;
- •History of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis;
- •Currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
- •Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;
- •Previous receipt of an investigational vaccine product for the prevention of MERS;
- •Prior exposure to MERS-CoV or camels;
- •Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2;
- •Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
- •Prisoner or participants who are compulsorily detained (involuntary incarceration);
- •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;
- •Reported active drug or alcohol or substance abuse or dependence.
研究组 & 干预措施
Part 1: Placebo Group F
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: INO-4700 Group A
Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: INO-4700 (Drug)
Part 1: INO-4700 Group A
Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: INO-4700 Group B
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: INO-4700 (Drug)
Part 1: INO-4700 Group B
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: INO-4700 Group C
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: INO-4700 (Drug)
Part 1: INO-4700 Group C
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: INO-4700 Group D
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: INO-4700 (Drug)
Part 1: Placebo Group G
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: Placebo (Drug)
Part 1: INO-4700 Group D
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: INO-4700 Group E
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: INO-4700 (Drug)
Part 1: INO-4700 Group E
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: Placebo Group F
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: Placebo (Drug)
Part 1: Placebo Group G
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: Placebo Group H
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: Placebo (Drug)
Part 1: Placebo Group H
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
干预措施: CELLECTRA™ 2000 (Device)
Part 1: Placebo Group I
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: Placebo (Drug)
Part 1: Placebo Group I
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
干预措施: CELLECTRA™ 2000 (Device)
Part 2: Parts 2A and 2B
Participants were planned to receive ID injection of INO-4700 based on optimal dose and regimen selection in Part 1 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4 or Week 8 and a booster dose at Week 48 (only for Part 2B participants were planned to receive a third dose).
干预措施: INO-4700 (Drug)
Part 2: Parts 2A and 2B
Participants were planned to receive ID injection of INO-4700 based on optimal dose and regimen selection in Part 1 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4 or Week 8 and a booster dose at Week 48 (only for Part 2B participants were planned to receive a third dose).
干预措施: CELLECTRA™ 2000 (Device)
结局指标
主要结局
Frequency of Adverse Events in Part 2
时间窗: Part 2: baseline up to Week 68
Frequency of Adverse Events in Part 1
时间窗: Part 1: baseline up to Week 48
Frequency of Injection Site Reactions in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage of Seroconverted Participants in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage of Participants with Injection Site Reactions in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage of Participants with Overall Immune Response in Part 1
时间窗: Part 1: baseline up to Week 48
Frequency of Injection Site Reactions in Part 2
时间窗: Part 2: baseline up to Week 68
Frequency of Adverse Events of Special Interest (AESIs) in Part 2
时间窗: Part 2: baseline up to Week 68
Percentage of Seroconverted Participants in Part 2
时间窗: Part 2: baseline up to Week 68
Frequency of Adverse Events of Special Interest (AESIs) in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage of Participants with Injection Site Reactions in Part 2
时间窗: Part 2: baseline up to Week 68
Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2
时间窗: Part 2: baseline up to Week 68
Percentage Antigen Specific Cellular Immune Response in Part 2
时间窗: Part 2: baseline up to Week 68
Percentage of Participants with Overall Immune Response in Part 2
时间窗: Part 2: baseline up to Week 68
Percentage of Participants with Adverse Events in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1
时间窗: Part 1: baseline up to Week 48
Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage Antigen Specific Cellular Immune Response in Part 1
时间窗: Part 1: baseline up to Week 48
Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2
时间窗: Part 2: baseline up to Week 68
Percentage of Participants with Adverse Events in Part 2
时间窗: Part 2: baseline up to Week 68
Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2
时间窗: Part 2: baseline up to Week 68
次要结局
未报告次要终点