Johnson & Johnson's investigational COVID-19 vaccine has been called a potential "game-changer." If all goes well, J&J hopes to seek emergency use authorization for its single-dose vaccine in February.
Allina Health is running the only clinical trial site in Minnesota part of the study called "ENSEMBLE."
The Phase 3 trial initially had a goal of enrolling 60,000 participants worldwide.
"They were obviously getting a lot more COVID cases than they were projecting initially so they didn't think they needed to enroll 60,000; they only needed to enroll 40,000," explained Dr. Frank Rhame, an infectious disease physician at Abbott Northwestern Hospital and site principal investigator of the trial.
Ultimately, the Phase 3 trial included about 45,000 participants. Allina Health enrolled 230 at its site in Minneapolis.
With COVID-19 disproportionately affecting communities of color, trial sites focused on getting more Black, Indigenous and people of color enrolled.
At the Allina Health site, BIPOC enrollment was about 11% which was not as high as Dr. Rhame said they had hoped for.
While enrollment is over, Dr. Rhame said their work continues as potential COVID-19 cases emerge from their enrollment group.
"Every time there's a potential case, you have a lot of work to do," Dr. Rhame said. "Really the study is not over until two years after the last person was vaccinated. So that's 2022 December. So we'll be following people for that whole time."
An ENSEMBLE participant can request to be unblinded and find out whether they got the placebo or vaccine.
"You don't get to unblind yourself today; you get to unblind yourself on the day you'd get access to the vaccine. The idea being that while it's a real contribution to participate in one of these trials, it shouldn't jump your place in line," Dr. Rhame explained.
According to J&J, the next step is to review the efficacy and safety data from the trial. Company scientists expect to get that information by the end of the month.
"We're hoping these milestones can come together by February, so that we can then consider applying for an emergency use authorization of our vaccine with the FDA, as well as regulatory filings in other countries," said Dr. Mathai Mammen, global head of research and development for Janssen, the pharmaceutical division of J&J, in a company interview.
The vaccine requires only one dose and, unlike Pfizer, it does not need ultra-cold storage.
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"I don't think we're going to have enough vaccine to get every American vaccinated before the summer without a third vaccine around and certainly from a global perspective, it's really desirable to get some additional vaccines," Dr. Rhame said.
While J&J said it feels confident in its one-dose vaccine, they have also started an ENSEMBLE 2 study which will give participants two doses of the vaccine spaced two months apart to see if a second dose might provide greater or longer protection.