UK to lead trial to see if two doses of Johnson & Johnson vaccine are better than one
The University of Kentucky will participate in a second COVID-19 vaccine trial that tests whether two doses of the Johnson & Johnson vaccine are more effective than one, university officials announced Tuesday.
Two hundred volunteers across the state are needed for the trial to test the vaccine from Janssen Pharmaceutica, a subsidiary of Johnson & Johnson.
“Individuals who want the Johnson & Johnson vaccine, now’s the time to get involved,” said Dr. Richard Greenberg, principal investigator of both Janssen trials at UK. UK is one of 20 sites around the country participating in the second arm of the study.
The first ENSEMBLE study, which began in November and also involves Baptist Health Lexington and Norton Healthcare Louisville, enrolled close to 900 people in Kentucky to gauge the efficacy of a single-shot of the Johnson & Johnson vaccine, which is poised to receive emergency use authorization from the U.S. Food and Drug Administration. If that happens, it will be the first single-dose vaccine approved to protect against the novel coronavirus.
What this latest trial will do is study whether two doses of that same vaccine are more effective than one, Greenberg said. Both trials are randomized double-blind placebo studies. For the one announced Tuesday, participants will receive either two doses of the actual vaccine or two doses of a placebo, 57 days apart.
Once the Johnson & Johnson vaccine receives emergency approval, which could happen as early as this month, UK will modify its double-blind two-dose placebo study. Those who received a placebo will receive a single dose of the actual vaccine, and the others, who already got an initial dose of the vaccine, will be given a second after that 57 day window. These two groups will then be compared to determine whether two doses is actually more effective at protecting against the virus than one.
The U.S. has only granted emergency approval to the Moderna and Pfizer-BioNTech vaccines, both of which require a booster shot to follow the initial dose and are close to 95 percent effective at thwarting severe coronavirus infections and death.
The Johnson & Johnson vaccine, slightly less effective than those from Moderna and Pfizer, is thought to be 72 percent effective in the U.S. at preventing infection, all together, and 85 percent effective at preventing severe disease and death — which, while lower than Moderna and Pfizer, is much higher than the yearly influenza vaccine, which usually boasts between 40 and 60 percent efficacy.
More than 45,000 people across the world have already started participating in the first Johnson & Johnson trial, and another 30,000 are expected to enroll in the second.
COVID-19 has infected more than 378,000 people across Kentucky and killed close to 4,100. Since the Moderna and Pfizer vaccines became available in mid December, more than 10 percent of Kentucky’s population has received at least an initial dose, according to the state Department for Public Health. The state is collectively focused on immunizing people in priority groups 1A and 1B, including people age 70 and older and K-12 personnel. On Monday, UK announced it would soon begin vaccinating people in group 1C, which includes essential workers.
Anyone over the age of 40 can sign up for UK’s two-dose study. Visit stopcovidky.com for more details.
