Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers
研究概览
简要总结
This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.
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
- 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 or deemed not clinically significant by the Investigator.
- •Body Mass Index of 18-30 kg/m^2, inclusive, at screening.
- •Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening.
- •Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome).
- •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, be post-menopausal, be surgically sterile or have a partner who is sterile.
排除标准
- •Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial from screening until 3 months following last dose.
- •Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day
- •Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
- •In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients).
- •Current or history of the following medical conditions:
- •Respiratory diseases
- •Hypersensitivity or severe allergic reactions to vaccines or drugs
- •Diagnosis of diabetes mellitus
- •Hypertension
- •Malignancy within 5 years of screening
- •Cardiovascular diseases
- •Immunosuppression as a result of underlying illness or treatment including:
- •Primary immunodeficiencies
- •Long term use (≥7 days) of oral or parenteral glucocorticoids
- •Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs
- •History of solid organ or bone marrow transplantation
- •Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease
- •Fewer than two acceptable sites available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles.
- •Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence.
- •Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
研究组 & 干预措施
Group 1: INO-4800
Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
干预措施: INO-4800 (Drug)
Group 1: INO-4800
Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
干预措施: CELLECTRA® 2000 (Device)
Group 2: INO-4800
Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
干预措施: INO-4800 (Drug)
Group 2: INO-4800
Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
干预措施: CELLECTRA® 2000 (Device)
Group 3: INO-4800
Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
干预措施: INO-4800 (Drug)
Group 3: INO-4800
Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
干预措施: CELLECTRA® 2000 (Device)
结局指标
主要结局
Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers
时间窗: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Adverse Events (AEs)
时间窗: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Change from Baseline in Antigen-Specific Cellular Immune Response
时间窗: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Administration (Injection) Site Reactions
时间窗: Day 0 up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
次要结局
未报告次要终点