Tulane to host COVID-19 vaccine trial

Amy Nankin, News Editor

Tulane University School of Medicine was chosen as a testing site for Janssen Pharmaceutica’s phase three clinical research study of a COVID-19 vaccine. The vaccine, known as Ad26.COV2.S, is in phase three of its clinical trial research as a COVID-19 preventative vaccine to evaluate its efficiency and safety. 

Worldwide, the study, called “ENSEMBLE,” will recruit approximately 60,000 adults 18 years old and older. Tulane will recruit roughly 1,920 participants and is searching for a diverse range of participants.

“Research has shown that certain diseases and medications may impact people differently based on their age, gender, and genetic background, including race and/or ethnicity,” Tulane Medical Center’s vaccine trial page says. “For example, COVID-19 has disproportionately impacted both older people and minority populations. Therefore, clinical research studies often require large and diverse numbers of volunteers to participate in a single study, sometimes thousands are needed to obtain reliable information. This helps ensure that medications and vaccines are generally safe and work for different types of people, especially those most impacted by the disease or illness.”

 “ENSEMBLE” is a randomized, double-blind, placebo-controlled trial that follows participants for up to two years and one month after the single shot dosage to evaluate long-term results. The study has a one-to-one placebo:vaccine ratio and is the only one to date that only requires a one-shot dosage. Tulane was chosen to participate in the study by the COVID-19 Prevention Network, funded by the National Institute of Allergy and Infectious Diseases. 

There are four trial sites in the New Orleans area: 143 S. Liberty St., 5620 Read Blvd., 4413 Wichers Dr. and 6324 W. Claiborne Ave. The study was recently approved to begin advertisement and is now searching for more participants. 

“The study started out enrolling just 18 to 59-year-olds who were well, and then the second group is 60 on up who are well, so meaning no comorbidities, but now the Data Safety Management Group has approved enrollment of subjects 18-59, both what we consider well and those with comorbidities,” Roberta McDuffie, director of clinical research at Tulane School of Medicine, said. “So as currently in the 60-plus group we are only enrolling people who do not have comorbidities at the moment, but that will change very shortly as soon as the first 2,000 are enrolled in that group just as we did in the 18-59. There will be a short three-day pause while the data safety monitoring board reviews the data and we expect at that point to be able to have enrollment of everyone from 18 up.”

Participants will have up to eight visits, either at home or at the study center, with a member of the clinical research staff or a study doctor. Participants will be given questionnaires, physical examinations and measurements of vital signs will be taken. Participants will be reimbursed for their time, but they will not be given any extra monetary compensation. 

“I think that for the entire country these studies are extremely important,” McDuffie said. “We’ve all seen the tremendous impact that COVID has had on our country, on individual families, on everyone’s abilities to work, live, the pandemic has been devastating and so I think being able to participant in a trial to try to find a drug that is a solution for this is extremely important. We’ve had volunteers who have been of the ages where they are extremely concerned about the potential for getting COVID, so they are very anxious to participate in a vaccine trial and help find a vaccine that will hopefully keep everyone from having to deal with this into the future.”

Lee Hamm, senior vice president and dean of the Tulane School of Medicine, sent an email to the Tulane community, citing that news of the trial has been circulating around campus and has generated excitement.

“There has been significant excitement at Tulane since the announcement of the Johnson & Johnson/Janssen COVID-19 Vaccine Trial, and I have received a lot of questions about it,” Hamm said. “Given the NOLA.com article earlier this week we anticipate even more inquiries, so I wanted to provide everyone with some basic information (and resources) for your personal information, and that you can share with any interested friends or family.”

Hamm explained specifics of the trial and encouraged students to research further, and said that specific questions on this trial can be directed to the Tulane Clinical Translational Unit by either email at [email protected] or toll-free call at 1.833.MY1SHOT.

“The work that we do makes it possible for us to have new drugs, new therapies, new devices that assist people and I think this is just one more case where we’re doing really important work to help develop a vaccine that will be hopefully one of the major solutions for this pandemic,” McDuffie said.