Southern Nevada has all the ingredients that make it a prime location for a COVID-19 vaccine trial — an ethnically and age-diverse population, the necessary medical infrastructure, and plenty of infection to go around.
“It’s here,” says Dr. Michael Levin of the virus. “We’re a hot spot.”
Indeed. The state’s seven-day moving positivity rate, a measure of the percentage of tests performed that are positive, has increased from 2.5 percent in late May to 22 percent on Tuesday.
Levin, a local pediatrician with two decades of experience in clinical trials, is overseeing the next phase in Las Vegas for Moderna’s COVID-19 vaccine, beginning this month. The company’s vaccine is a leading candidate in the global race, having generated antibodies in all 45 participants in its first phase of trials, published last week in the New England Journal of Medicine.
Wake Research, which is conducting the effort for Moderna, is seeking 500 participants in Las Vegas as well as thousands in five other cities – San Diego, California; Chattanooga, Tennessee; Dallas, Texas; and Raleigh and Fayetteville, North Carolina.
Perhaps more than other states, Nevada’s fortune is inextricably linked to vanquishing the virus. The state’s tourism-based economy is suffering unprecedented losses.
Levin is looking for volunteers 18 years of age and older, in good health and in poor. Only those who are immunocompromised or have tested positive for COVID should not apply.
“We want essential workers from all walks of life. Dentists, teachers, casino workers,” says Levin, who is conducting the blind study at Wake Research-Clinical Research Center of Nevada.
Volunteers will be tested for COVID and for antibodies. Half of participants in the blind study will receive the vaccine while the other half receive the placebo.
Some studies indicate the new coronavirus does not generate long-lasting immunity, but Levin says effective vaccines are still possible.
“That’s why they are following participants for two years and doing blood work along the way,” says Levin. “And that’s probably the reason they are giving two doses one month apart.”
The Chicken Pox vaccine was ineffective with one dose, hence, the booster, says Levin.
“There are so many unanswered questions. It’s a brand new animal. It’s going to take time to learn everything,” Levin says, adding “we don’t need a 100 percent effective vaccine. They’ll be looking at the effect on the severity of the illness, too.”
The Moderna vaccine is made with genetic material rather than actual virus, a property that facilitates mass production.
“This can be produced a lot faster,” says Levin, who anticipates 300 million doses will be ready upon approval if the vaccine looks promising and enjoys “continued efficacy and safety.”
“Messenger RNA is the genetic material of this virus,” says Levin. “It’s translated into proteins in the cellular machinery. To get in the cell it uses the perfusion of the spike protein.”
“Encased in a lipid, it can slide in through the cell membrane. It’s degraded and it doesn’t go into the nucleus, but in the time that it’s around it produces cells to go into our immune system,” he says. “If you get exposed to the wild COVID, your body will pick up the spike proteins and neutralize them before it can infect.”
About half of the study group of 45 volunteers reported some flu-like symptoms, but Levin says a third dose administered to that group has been eliminated.
Volunteers will be required to sign a consent form, undergo an examination, complete a medical history, be swabbed for COVID and provide a blood sample. They’ll be asked to provide feedback via a smartphone application for seven days following the vaccination, return three weeks later for the second dose, and provide researchers with data for another seven days.
“About half will get some side effects such as swelling, hardness, redness, pain, swelling of lymph nodes under the arm,” Levin said. “We need to know about it.”
Those who exhibit even “the mildest symptoms of COVID” will be tested. Those who are positive will be followed for 14 days to a month until they clear the virus, says Levin.
Volunteers will be tested for antibodies at the end of the first and second years.
“It’s case-driven. We’re looking for people who get it (the virus),” says Levin. “Let’s say you have 50 people who got COVID and 90 percent had the placebo. They (researchers) could say ‘we’ve got it.’”
Those who are interested in participating in the vaccine trial should go to www.covidstudies.org to register.