A COVID-19 vaccine in the nose?
One squirt per nostril and you're protected from COVID-19?
That's the intent of a vaccine that's about to be tested in a clinical trial, which will run at three U.S. research sites including the Gamble Center for Vaccine Research at Cincinnati Children's Hospital Medical Center.
What's promising about the vaccine under study is that it is expected to quickly stop COVID-19 spread from those who get the two-squirt dose.
“It has the potential to stop viral infection at the very earliest stages, preventing infection of the nose and upper respiratory tract,” said Dr. Paul Spearman, director of the division of infectious diseases at Cincinnati Children's and lead investigator for clinical trials of the CVXGA1 vaccine.
That could be a turn of events for the coronavirus pandemic, he said, because current vaccines cannot promise the prevention of early stages of COVID-19, which get into the nose and can cause upper respiratory issues, though they are highly effective at preventing severe illness and death.
Cyanvac LLC of Athens, Georgia, a small pharmaceutical manufacturing company founded in 2017, developed the vaccine that's about to be tested. CVXGA1 employs a live vector virus that hasn't been used in humans so far.
“This is a naturally-occurring canine respiratory virus that is not known to cause any harm in humans who have been exposed to it,” Spearman said.
The vaccine has been engineered to express the COVID-19 spike glycoprotein, which is the same spike protein that's in the other vaccines, he said.
The vaccine is squirted into each nostril; then it replicates and generates an immune response, he said.
The clinical trial at the Cincinnati Children's research center is expected to begin the week of Sept. 14, and recruitment is underway, but Spearman said that could be “a little tricky.”
“We are trying to recruit individuals who've had no COVID vaccine and have not been infected with COVID-19,” he said.
Adults ages 18-75 will be enrolled in the clinical trials, with the first part of the trial to include those 18-55, and the second 56-75, officials said.
The study will go on for a year, and will require 10 visits to the research center in Avondale. Any individual who takes part will be paid $975, officials said.
The Cincinnati study will include 15-20 participants, and, nationwide, trial coordinators are looking to test the vaccine in about 80 people.
There will be no placebo in the trial, Spearman said.
Those who take part will get specific instructions, but basically, the trial is expected to go on for a year. And while the participants will get a non-needle vaccine (because it is intranasal) of CVXGA1, they will have to have blood drawn so researchers can examine their immune response, including antibodies.
Spearman could not be sure when CVXGA1 could be approved for use, but said it's possible that if clinical trials go well, the FDA could give the OK for use by mid-2022.