Kentucky Healthcare Systems Gear up for Large Phase 3 ENSEMBLE Study Investigating J&J’s COVID-19 Single Dose Vaccine Candidate

Kentucky Healthcare Systems Gear up for Large Phase 3 ENSEMBLE Study Investigating J&J’s COVID-19 Single Dose Vaccine Candidate

Healthcare providers in Kentucky have been selected for a major global Phase 3 COVID-19 vaccine clinical trial, including University of Kentucky (UK) HospitalBaptist Health Lexington and Norton Healthcare in Louisville serve as trial site locations for the massive ENSEMBLE trial sponsored by Janssen (Johnson and Johnson). Investigating the safety and efficacy of the sponsor’s investigational COVID-19 vaccine candidate Ad26.COV2.S, also referred to as JNJ-78436735, this randomized, controlled trial involves a single dose versus placebo in approximately 60,000 participants including a sizable portion of the volunteers targeted over 60. This is the largest of the COVID-19 vaccine trials to date. The Kentucky trial site organizations (UK Hospital, Baptist Health Lexington and Norton Healthcare) have signed up to enroll at least 2,000 local volunteers for this pivotal clinical trial. Those individuals over 18 who meet all the inclusion criteria, such as adults with and without health issues that expose them to greater risk for severe COVID-19, may participate in this important study.

Where do those interested in participating go to learn more?

They can go online for more information, such as pre-screening questionnaires. Moreover, potential volunteers can hear from the research team to discuss eligibility. The healthcare systems will keep all information confidential.  Completing the questionnaire doesn’t oblige the individual to participate.

Will volunteers be compensated?

Yes.

Who is the Principal Investigator in Kentucky?

Dr. Richard Greenberg, an Infectious Disease Specialist based in Lexington, with over 48 years of experience in the medical field. Recently, Dr. Greenberg was quoted in Spectrum News 1, “The most important effort to end this pandemic requires the cooperation and participation of many scientists, doctors, public health leaders, politicians and the people of the world.” The seasoned medical professional explained in the local news that this opportunity to participate in ENSEMBLE was not only a great opportunity for the university but a personal “honor.”

The Vaccine Candidate

This vaccine candidate known as A26.COV2.S (JNJ-78436735) was developed by Johnson and Johnson and subsidiary Janssen Pharmaceutical in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School.  The candidate is an adenovirus-based vaccine genetically modified so it can no longer replicate in humans and cause disease. The collaborators actually developed and tested multiple candidates employing the Janssen Advac® technology platform, which led to the present candidate recombinant for the prevention of SARS-CoV-2. This lead candidate, in addition to leveraging AdVac, also uses PER.C6® technology. This combination of life science-based technologies were used by Janssen to develop and produce the company’s vaccine for Ebola known as Ad26.ZEBOV.

The ENSEMBLE Study

The ENSEMBLE Study (NCT04505722) is officially titled “A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 years and Older.” Targeting up to 60,000 participants, participants either receive a placebo or an intramuscular (IM) injection of the investigational product Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as a single dose vaccine on Day 1.

The sponsor, Janssen Vaccines & Prevention B.V., (Leiden, Netherlands) a division of Janssen Pharmaceuticals (part of Johnson and Johnson family of companies) has recruited over 260 trial site organizations to participate in this massive study.

Lead Research/Investigator

Richard Greenberg, MD, an Infectious Disease Specialist

Call to Action: Those individuals in Kentucky interested in volunteering should check out the study website sponsored by the University of Kentucky Center for Clinical and Translational Science. For an interview with Principal Investigator Dr. Greenberg, see the link.