CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization, has announced that its 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,” said David Mayleben, Ph.D., 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,” said 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,” said 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.
From CTI Clinical Trial and Consulting Services
