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Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336410
Recruitment Status : Active, not recruiting
First Posted : April 7, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations (CEPI)
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: INO-4800 Device: CELLECTRA® 2000 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: 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.
Drug: INO-4800
INO-4800 will be administered ID on Day 0 and Week 4.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.

Experimental: 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.
Drug: INO-4800
INO-4800 will be administered ID on Day 0 and Week 4.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.

Experimental: 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.
Drug: INO-4800
INO-4800 will be administered ID on Day 0 and Week 4.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 52 ]
  2. Percentage of Participants with Administration (Injection) Site Reactions [ Time Frame: Day 0 up to Week 52 ]
  3. Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 52 ]
  4. Change from Baseline in Antigen-Specific Binding Antibody Titers [ Time Frame: Baseline up to Week 52 ]
  5. Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response [ Time Frame: Baseline up to Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 科派斯塔克说,人们对经济紧缩和欧元稳定的忧虑使得过去一年欧元区城市的生活成本指数降低了,而加拉加斯能跻身前20则是由于人为的高汇率管制。
    2.这里没有人能够回答你问的任何关于击剑的问题。还是去google一下吧。
  • 2015年硅藻泥十大品牌排行榜
  • Yes, pensions for retirees at state and municipal levels are preventing recovery. Corporate pensions are also a big problem, widening America's inequality gap: Drug company McKesson's CEO has been boss for 14 years, but will retire with a $159 million pension, while the income of America's average wage earner has stagnated for 30 years.
  • 杨国强委员: 用信息化赋能建筑业
  • 如果你有什么问题,就到我的办公室里来讨论,别把我堵在厕所里。
    我只是忍不住希望,随着《广告狂人》的终结,一个时尚阶段也能终结,在这个阶段,设计师们被困于过去的时代,几乎窒息——至少是困在20世纪60年代(不要忘了,60年代初与50年代末非常相似)至70年代初。
  • 骑行背带
    9. The 2012 Ig Nobel Anatomy Prize
  • 4.菲亚特 品牌喜爱度:-7%/排名:85
    这场可怕疫情的后果持续不断。
    *剧情类最佳客串男演员:汉克?阿兹利亚(Hank Azaria),《清道夫》(Ray Donovan)
    9、邦德经历风险无数却总能死里逃生。当然,人物本身是虚构的。有意思的是,研究证明,肌肉男更皮实。实际上,肌肉不发达对男性来说,可能很要命。(可能就是发达的肌肉让他得以活命的吧,我怀疑他会死于心脏病或前列腺癌)。

Exclusion Criteria:

  • Xinhua reported in 2015 that the MOE and five other central government departments were putting together a task force to ensure that football thrives in the country's schools.
    The other issue with tanking is Philly, Phoenix, and Brooklyn are all bad teams. It's going to be hard to outflank those outfits.
  • One of the best James Bond theme songs wasn't actually played over the opening credits, so we're giving it our first honorable mention. This enormously romantic song from On Her Majesty's Secret Service is one of the few James Bond themes that helps tell the story of the film, in which our hero finally meets the love of his life. (Alas, it was short-lived.) Satchmo warbles his trademark warble, our hearts melt, and a classic is born.
    Better still was Iain Roberts, global managing director of the design company Ideo, who asked a question to which I hope never to hear the answer: “How to activate insights around latent mobility or multimodal needs?”
  • Ann Hand
    银行、基金公司和保险公司从内地涌向香港,收购这里的高端写字楼,导致香港政府宣布将释放更多土地,在火爆的城市中心地段进行商业再开发。
    不过,企业在年终奖上的吝啬,造成的影响可能不仅仅是破坏员工的春节假期,还可能回头反噬雇主:39%的回复者表示如果年终奖不能恢复正常,他们会另谋高就,这一比例比2015年高了2.3个百分点。
    [':tn]
  • 3.The End of the One-Child Policy
    The Harvard article suggests that protecting the brain with a heart-healthy diet could be the key to warding off dementia and keeping your memory intact well into your golden years. Some studies have suggested certain foods have a positive impact on memory, but no study thus far has revealed the existence of a miracle food. The idea that a heart-healthy diet could also prove beneficial to the brain and memory has become popular with doctors studying Alzheimer's disease and dementia. Some of the risk factors associated with heart disease are similar to those associated with dementia and Alzheimer's. Foods recommended for a heart-healthy diet include fruits, vegetables, and whole-grain bread, as well as beans, nuts, and olive oil. If you can't use every one of these 10 scientific secrets to a perfect memory, a healthy diet might help you avoid losing it!
    The United Kingdom ranks No. 3 overall. It ranks No. 4 in Power and No. 5 in Cultural Influence.
  • 房价连跌10个月 房地产造富时代一去不复返

    • Respiratory diseases
    • “这可是短期内的大幅跃升:当我还是内政部长时仅有30个案例,今天则是1400。”
    • Diagnosis of diabetes mellitus
    • Hypertension
    • 供给侧改革大背景下 地板行业弘扬工匠精神
    • Cardiovascular diseases
  • 经济运行缓中趋稳、稳中向好;

    • Primary immunodeficiencies
    • Long term use (≥7 days) of oral or parenteral glucocorticoids
    • 女性地位继续上升。
    • 新环保法步步逼近 涂料迎“绿色革命”
    • [st?:]
  • Make it dangerous, this will help you keep your Watson happy.
    单词embrace 联想记忆:
  • 美国电话电报公司
  • I may say "I'm terminating you because you didn't meet performance measures." I'm not going to say it's because you're a pain in the butt and piss people off every time you interact with them.
    Will Washington's tentative truce continue?
    保险代理人员也增加了93.62万人,总人数逾560万人。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336410


Locations
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United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Investigators
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Study Director: ShuPing Yang, MD, PhD Inovio Pharmaceuticals
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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04336410    
Other Study ID Numbers: COVID19-001
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Inovio Pharmaceuticals:
DNA vaccine
Electroporation
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases