Tulane University is seeking nearly 2,000 volunteers for a coronavirus clinical trial that's expanding in the New Orleans area, one of five late-stage vaccine trials taking place in Louisiana.
The Phase 3 trial is for a vaccine candidate known as Ad26.COV2.S from Janssen Pharmaceutical Companies, a division of Johnson & Johnson.
The 1,920 volunteers will make up a fraction of the 60,000-person study, which began in September and will follow participants for two years, though scientists expect to have a vaccine ready in 2021. Tulane, like many other research institutions, is partnering with the National Institutes of Health to conduct the trials.
According to a federal database, four other pharmaceutical companies are also testing vaccines in Louisiana: AstraZeneca in Monroe and Lake Charles; Moderna in Baton Rouge and Metairie; Pfizer in New Orleans, Metairie and Shreveport; and Novavax in Baton Rouge, Metairie and Shreveport.
Ochsner Clinic Foundation and the Southeast Louisiana Veterans Health Care Center are also participating in the Johnson & Johnson trial, along with three private test sites in the New Orleans area, according to a federal database. It's not clear how many volunteers they are seeking or the timeline for those trials.
The Johnson & Johnson vaccine relies on the same technology used to develop vaccines for many other viruses, including Ebola.
It begins with a harmless live virus known as Adenovirus26, or Ad26, which can invade cells but not multiply inside of them.
Scientists then inserted certain coronavirus genes into Ad26 to produce the spike protein of COVID-19 without causing infection. That protein will float through the body’s bloodstream, teaching it to block the real spike-covered coronavirus by producing antibodies.
“This has been tested with other vaccines and this approach has been used extensively,” said Dr. Patrice “Patrick” Delafontaine, the executive dean of Tulane University Health Sciences Center. “It has been tested a lot in animals, particularly in nonhuman primates, and has elicited a strong antibody response.”
In the past seven months, Louisiana hospitals have had to meet countless challenges as the coronavirus strained their staff and hospital capacity.
Tulane has set up trailers at New Orleans East Hospital, West Jefferson Medical Center and two locations on the Tulane campus where researchers will administer the vaccine to volunteers.
Unlike other vaccines, which require two doses, participants will get a single shot. Half will receive a placebo. Neither participants nor investigators will know who gets the real vaccine, in what’s known as a randomized, double-blind, placebo-controlled format.
Like any clinical trial, there are benefits and risks. And as the trial expands the number of enrollees and then potentially millions of people around the world, the likelihood of side effects rises.
“There is always a risk when something is brand new,” said Dr. Julio Figueroa, chief of infectious diseases at LSU Health New Orleans. “When you give it to thousands of people, you don’t necessarily find the things you do when you give it to millions of people.”
Risks of vaccines in trials are unknown, but manufacturers point to similar drugs as evidence. The most common side effects are pain, tenderness and redness at the injection site, headache, chills, joint pain, muscle pain, tiredness, generally not feeling well, nausea and fever. The trial's informed consent document describes the risk of allergic reactions and vaccine-enhanced disease, a rare but severe response when the vaccinated person eventually encounters the virus.
This trial, known as the ENSEMBLE study, was paused in mid-October after one participant reported an unexplained illness. The study resumed 11 days later after an independent investigation.
Figueroa said pauses are normal in clinical trials and potentially reassuring during a whirlwind vaccine process.
After a vaccine for coronavirus showed promising results in a 45-person study conducted by biotech company Moderna, research sites in New Orle…
“These stops are a signal that the usual safeguards are in place,” said Figueroa, who is affiliated with some of the hospitals testing the vaccine but not directly involved with this trial. “This is something being done in an expedited fashion, not in a haphazard fashion.”
Louisiana has been a popular location for coronavirus vaccines because of the early rise of the virus in the state and because the diverse population allows for testing of different races, ages and people with comorbidities.
And as the virus rages on, hitting grim milestones across the U.S. and overloading hospitals in other countries, a safe, effective vaccine is crucial.
“The only other way to get to that point of 'herd immunity' is for people to get infected,” said Figueroa. “This thing is very contagious so that means a lot of people will get it. A vaccine is going to be very important to get back to a semblance of normalcy.”
The Johnson & Johnson trial will likely have clear results by the third quarter of 2021, Delafontaine said. Other vaccines may be available earlier — as soon as the end of the year.
“The faster we can show efficacy, the faster it will be available,” said Delafontaine.
Participants are typically compensated for their time. For more information about the Johnson & Johnson vaccine, visit vaccine.tulane.edu.
Dr. Alex Billioux’s daughter held up a sign over the last weekend of Carnival that carried a public health message: “catch beads, not the flu.”