Phase Ib, Placebo-controlled Randomized Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of INO-4201 Followed by Electroporation as a Booster Vaccination in Healthy Volunteers Who Have Previously Received the VSV-ZEBOV Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Incidence of adverse events by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14.
研究概览
简要总结
Ebola virus disease (EVD) is a serious illness with a high fatality rate. Currently only one vaccine is available, VSV-ZEBOV/Ervebo; this vaccine is clinically effective and has been deployed as a preventive measure during recent Ebola outbreaks. The durability of protection afforded by this vaccine is unknown, however, and it is thought that a booster vaccination may be required to maintain immune responses. Recently, a synthetic DNA vaccine, INO-4201, was tested in humans and showed good immunogenicity and an enhanced safety profile.
This study aims to test whether the DNA-based candidate INO-4201 can be used as a booster in healthy volunteers previously vaccinated with VSV-ZEBOV.
详细描述
This randomized placebo-controlled phase 1b trial will evaluate the safety, tolerability and immunogenicity of the DNA-based vaccine candidate INO-4201 in healthy adult volunteers who previously received a single injection of VSV-ZEBOV. These participants will be randomized to either INO-4201 or placebo, injected once intradermally (ID) followed by electroporation (EP) with the CELLECTRA2000 device. Volunteers will be observed for 1 hour after vaccination and will attend follow-up visits at the Clinical Trials Unit in the 24 weeks after injection (8 visits in all).
Primary outcome parameters are (i) the incidence of adverse events in relationship with INO-4201 from day 0 to 14, and (ii) geometric mean titers (GMT) of EBOV-GP-binding IgG antibodies at 4 weeks post-injection.
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
- •Has provided written informed consent prior to screening
- •Males and females ≥ 18 years old
- •Previously vaccinated with a single dose of VSV-ZEBOV at any dose between 10^5 and 10^8 pfu more than 6 months prior to inclusion
- •Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
- •Has an acceptable site for ID electroporation considering the deltoid and anterolateral quadriceps muscles
- •Is post-menopausal, or surgically sterile, or has a partner who is sterile, or uses a medically effective contraception with a failure rate of <1% per year when used consistently and correctly from screening until 6 months following last dose.
排除标准
- •Female volunteers who are pregnant or breastfeeding at screening or prior to dosing
- •Administration of an investigational compound either currently or within 30 days of Day 0
- •Prisoner or volunteers who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
- •Active drug or alcohol or substance abuse or dependence
- •Planned administration of another Ebola vaccine (including rVSV-ZEBOV and Ad26/MVA-BN-Filo vaccines) during the study period
- •Administration of a live vaccine in the 21 days or an inactivated vaccine in the 14 days before planned injection
- •Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose.
- •Temporary exclusion criteria:
- •Acute disease at the time of randomization
- •Active skin lesions at the potential injection site
- •Temperature ≥38.0°C at the time of randomization
- •Recent receipt of a SARS-CoV-2 vaccine with final dose <4 weeks prior
结局指标
主要结局
Incidence of adverse events by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14.
时间窗: Days 0 - 14
Primary safety outcome
Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection
时间窗: Days 0 - 28
Primary immunogenicity outcome
次要结局
- Occurrence of solicited local and systemic reactogenicity signs and symptoms(Days 0 - 14)
- Occurrence of unsolicited adverse events(Days 0 - 28)
- Occurrence of serious adverse events (SAE)(Days 0 - 168)
- GMTs of EBOV-GP-binding antibodies as measured by ELISA(Weeks 2, 12, 24)
- GMTs of neutralizing antibodies(Weeks 2, 4, 12, 24)
研究者
Angela HUTTNER
Principal Investigator
University of Geneva, Switzerland