FOR IMMEDIATE RELEASE [Cincinnati, OH ~ September 30, 2020]
CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization announces that their research site has dosed the first subject in Janssen’s large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for the COVID-19 vaccine candidate, JNJ-78436735, being developed by its parent company, Johnson & Johnson. The site is the lead enroller of the study, with dozens of patients randomized in the first week, and more scheduled for dosing in the next several.
“We are thrilled to be the first site to enroll a subject on this important trial,” states David Mayleben, PhD, Vice President, Research Site Services at CTI. “This moment is a testament to all those involved in this trial, from the researchers to the study participants, who are all working together to find a solution for the COVID-19 pandemic.”
The CTI Clinical Research Center also welcomed visitors last week from Operation Warp Speed, to discuss this milestone. Dr. Moncef Slaoui, Chief Advisor, and General Gustave F. Perna, Chief Operating Officer, visited the unit to speak with Dr. Antoinette Pragalos, the primary investigator, and other CTI staff about enrollment, operations for the trial, and to offer additional assistance.
“I’ve been extremely impressed by the work I’ve seen being done in [the pharmaceutical] industry,” remarked Dr Slaoui during his visit. “The people in this industry are saving our lives every day, and most of us don’t even know it.”
"CTI is extremely proud to collaborate with Janssen, Johnson & Johnson, and their partners, The U.S. Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA), on this important COVID-19 vaccine study as we work toward providing a solution to the coronavirus pandemic," according to Timothy J. Schroeder, Founder & CEO of CTI.
The initiation of the ENSEMBLE trial, which was announced last week, follows positive interim results from Janssen’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online imminently. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.
Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles. They are committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol. They have continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. They are committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.
CTI is currently managing more than twenty active COVID-19 trials for treatment and prevention, in addition to their work supporting those in the community who are struggling in the wake of the economic downturn. CTI, now in its third decade, is one of the 20 largest CROs in the world with associates in more than 60 countries across six continents. The company was recently named the #1 CRO in the world for quality at the 2020 CRO Leadership Awards, outperforming nearly 30 other recognized CROs from around the world.
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hematology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, MENA, and Asia-Pacific. For more information visit www.ctifacts.com
PHASE 3 ENSEMBLE STUDY
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those that are over age 60. The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. In order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites which have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated.
Built on a legacy of purpose-driven actions and a commitment to diversity and inclusion, Johnson and Johnson aims to achieve representation of populations that have been disproportionately impacted by the pandemic in the implementation of its COVID-19 Phase 3 trial program. In the U.S., this includes significant representation of Black, Hispanic/Latinx, American Indian and Alaskan Native participants.
ENSEMBLE is being initiated in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS.
For more information on Johnson & Johnson’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.