Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number of Participants with Injection Site Reactions
研究概览
简要总结
This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
入排标准
- 年龄范围
- 18 Years 至 50 Years（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;
- •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);
- •Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (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 three (3) months following last dose;
- •Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
- •Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
- •Previous receipt of an investigational vaccine product for prevention of Lassa Fever;
- •Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz;
- •Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
- •Current or anticipated concomitant immunosuppressive therapy;
- •Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.
研究组 & 干预措施
INO-4500 Group A
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.
干预措施: INO-4500 (Drug)
INO-4500 Group A
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.
干预措施: CELLECTRA™ 2000 (Device)
INO-4500 Group B
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.
干预措施: INO-4500 (Drug)
INO-4500 Group B
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.
干预措施: CELLECTRA™ 2000 (Device)
Placebo Group C
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.
干预措施: CELLECTRA™ 2000 (Device)
Placebo Group C
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.
干预措施: Placebo (Drug)
Placebo Group D
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit..
干预措施: CELLECTRA™ 2000 (Device)
Placebo Group D
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit..
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Injection Site Reactions
时间窗: Day 0 up to Week 48
Number of Participants with Adverse Events (AEs)
时间窗: Baseline up to Week 48
Number of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Baseline up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude
时间窗: Day 0 up to Week 48
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
时间窗: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralization Assays
时间窗: Day 0 up to Week 48
次要结局
未报告次要终点