A nonprofit publication of theKentucky Center for Public Service Journalism

UK, Baptist Health Lexington, Norton Healthcare partner in Phase 3 COVID-19 vaccine clinical trial


By Mallory Powell
University of Kentucky

The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, called the ENSEMBLE trial, to evaluate Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.

The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000 people, including significant representation from those 60 and older.

Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates. To date, more than 100,000 individuals have been vaccinated with a Janssen AdVac-based vaccine.

Principal Investigator Dr. Richard Greenberg (left) and CCTS Clinical Operations Director Linda Rice, BSN, RN, CCRC. (Photo by Mark Cornelison)

英国,施洗健康列克星敦和诺顿医疗保健研究团队计划为审判注册至少2,000名本地志愿者,这对18岁以上的人开放,符合纳入标准,包括有关的成年人,没有与进步风险增加相关的健康问题。严重的covid-19。

英国Richard Greenberg博士,一位传染病专家,具有四十年的疫苗发展经验,引领了这一当地的努力。

“向我们的英联邦服务就是为什么英国创建的原因,”英国总统伊利卡州议员说。“我们正在尽我们所能来应对和干预这种大流行,现在包括领导疫苗临床试验。我们为与我们的社区合作的机会感到骄傲 - 特别是那些最受影响力的机会 - 努力为与Covid-19斗争做出贡献。“

Janssen has joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including publishing the complete study protocol.

该研究的主要调查员Greenberg为审判带来了广泛的专业知识。他在疫苗发展中的历史包括在印度的比哈尔尔服务,以获得世界卫生组织根除天花的成功努力,导致在列克星敦的VA和与军队合作开发瘟疫的合作疱疹预防研究,以开发瘟疫疫苗,botulism和smallpox。他领导了超过28项疫苗试验,并发布了150多个同行评审篇章。

“最重要的努力结束这场大流行再保险quires the cooperation and participation of many scientists, doctors, public health leaders, politicians, and the people of the world,” Greenberg said. “To have a chance to be a small part of the solution is not only an opportunity for the university but an honor for me. I thank the many people working so hard at all levels of this project — from those behind the scenes to all of our volunteers — because they know how important this to the world.”

A member of the study team takes a nose swab of a young man. (Photo by Mark Cornelison)

Individuals interested in learning more about participating in the trial can visitStopCOVIDKy.com要查找更多信息并回答预先筛选的问卷,之后研究团队可以与他们联系以确定是否有资格。所有信息都是机密的,并完成调查问卷不赞成您加入该研究。合格的参与者将得到赔偿。

在英国,通过英国临床和翻译科学中心(CCTS)的基础设施组织和实施该审判,其使命是加速改善健康的发现。CCTS还可作为所有三个站点的协调中心。

“通过高质量的翻译研究的支持,临床和翻译科学中心致力于创新的刺激,重点是团队科学,劳动力发展和社区参与。Covid-19是一种紧急和关键的公共卫生危机,如果没有CCTS基础设施,英国的参与将不可用。“CCTS博士菲利普·凯恩斯博士说,我们是骄傲和渴望与格林伯格博士的合作伙伴。

该研究的浸礼会健康列克星敦的军团由大卫博士Dougherty,一种传染病专家以及临床研究团队带领。

“我们很自豪能与其他提供商合作,将医疗保健和健康的最新创新带给我们的社区,”施洗卫生卫生州施洗者卫生州长威尔·莱辛顿总裁William G. Sisson说。

在路易斯维尔,该研究的Norton Healthcare Arm由传染病专家和系统流行病学家Paul Schulz博士领导。

“Norton Healthcare has one of the largest community healthcare system-based research portfolios in the country, and we know our employees and members of the community will step up to this opportunity to participate,” Schulz said.

To learn more about the trial and participating, go toStopCOVIDKy.com。Additional information is also available at Janssen’s ENSEMBLE网站

ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

该项目全部或部分资助了助理助理秘书办公室的联邦基金,生物医学先进的研发管理局在其他交易协议HHSO100201700018C下。

英国临床和翻译科学中心得到临床和翻译科学奖的支持。

Want more great content like this?

Become a sustaining member of KyForward with a tax-deductible donation today and help us continue to provide accurate, up-to-date local news and information you can depend on.

Click here to donate now!


相关文章

Leave a Comment