Doctors Vladimir Berthaud, left, and Rajbir Singh stand ready for volunteers in two clinical trials for vaccines designed to stimulate patients’ immune system so it resists infection by COVID-19. Photo by Lucius Patenaude, Meharry Medical College
By Clint Confehr
NASHVILLE, TN — Meharry Medical College will soon conduct clinical trials for two COVID-19 vaccines before those Sanofi and Novavax corporate products may be used by the general public.
Clinical trials for three other vaccines are set for volunteer patients in Nashville. They’re at Vanderbilt University Medical Center and Clinical Research Associates on Church Street at 15th Ave., North.
Dr. Vladimir Berthaud, professor of internal medicine in Meharry’s Division of Infectious Diseases, and Dr. Rajbir Singh, director of the college’s Clinical and Translational Research Center, said Meharry’s primary mission — education — includes Operation Warp Speed to provide Americans with a safe and effective vaccine to protect them against COVID-19.
Berthaud, principal investigator for those studies, and Singh,co-investigator and Meharry’s contact person for volunteers, told the Tribune they want to enroll approximately 300 people willing to help test the medicine. Enrollment is October-February.
“Our target is to enroll at least 25 per week,” Singh said. Already, nearly 40 people have expressed interest in receiving an injection of one of those vaccines during Meharry’s clinical trials. Volunteers may contact Singh at (615) 327-6820 or rsingh@mmc.edu.
Volunteers, Berthaud said, will have two years of medical follow-up.
Before a volunteer receives a shot, an informed consent form must be signed. That’s significantly different from the infamous syphilis study in Tuskegee from 1932 until 1972 when the Associated Press reported the U.S. Public Health Service lied to participants, saying they were being treated for bad blood, history.com states.
“This is different,” Singh said. “We will inform them and they will make a decision based on all the factors. They’ll be asked; ‘Do you have any questions?’”
Berthaud said, “People have reasonable skepticism,” heightened by concerns about social injustice. He acknowledges “front-line workers” are at a greater risk of contracting COVID-19 and that it’s spread by personal contacts affected by social structure such as a home where many relatives live in close quarters. Investigators conducting clinical trials “can’t do anything about that,” he said, “but they can provide the best information they have.”
Asked if informed consent means there’s a total waiver of responsibility, or if there’s insurance to address costs associated with side effects and/or related injury, Singh said, “They are to be covered by the study.”
Fever, malaise and fatigue are potential reactions to a vaccine, he said. As of Aug. 21, Meharry had not received specifics about possible reactions to the Sanofi or Novavax medicines.
Nevertheless, Berthaud said, “You cannot get the virus from the vaccine. We are not injecting any virus. We’re injecting a protein” to protect the body by strengthening its immune system.
“It may not provide complete protection,” Berthaud continued. “We don’t know the level of protection. There’s a chance that you won’t be protected.”
There’s some compensation for participants, but it’s a fixed amount and shouldn’t be compared to a volunteer’s employment income.
Asked for a dollar value of the vaccine trials at Meharry, Berthaud replied, “We don’t have a final budget.” Singh said, totals won’t be known until the job is done. “Nationally, it’s in the billions of dollars.”
Operation Warp Speed is a public-private partnership between federal agencies, corporations, universities and research institutions to deliver 300 million doses of a safe and effective COVID-19 vaccine by January, defense.gov states.
According to sanofi.com, “If the data are positive, the companies can request U.S. regulatory approval in the first half of 2021.” Sanofi, a French multinational pharmaceutical company, is collaborating with GlaxoSmithKline, a British multinational pharmaceutical company, for its ingredient to enhance immune response, and possibly reduce the amount of vaccine protein required per dose.
Noravax, a biotechnology company headquartered in Gaithersburg, Md., has its own ingredient to enhance the immune response and stimulate high levels of neutralizing antibodies.
“We are looking for opportunity to educate the community about the coronavirus,” Berthaud said, emphasizing the medical college’s principal mission.
There are many kinds of viruses, he continued. They’re the smallest of germs, less complex than bacteria (salmonella, staphylococcus, e-coli and listeria). Their lifecycle can’t continue without a host to multiply. A virus uses host cells to reproduce its hereditary material. It’s an infectious particle that, once inside a body, uses the host’s “machinery” to make copies of itself. That infection can cause disease unless the body’s immune system can overcome the infection.
Clinical trials with human volunteers are among the few remaining steps toward finding an effective medicine.
Meharry’s work on this is to evaluate the safety and effectiveness of the vaccines to see if they will keep people from getting sick.
Like annual flu shots, the intention is to keep people from getting sick. It’s not a treatment after infection.
Berthaud and Singh were interviewed Aug. 21.
Aug. 5, Clinical Research Associates announced it’s enrolling 4,000 volunteers for two COVID-19 vaccine studies. They began in mid-August. Enrollment continues until all spots are filled. These studies are also part of Operation Warp Speed. The vaccines are being studied for efficacy and safety. Volunteers may participate if they’re at least 18 years old, generally healthy, and well-managed on medications. They can sign-up by: visiting covidnashville.com; emailing recruiter@CRAnashville.com; or calling (615) 329-2222. Participants will be compensated for their time and will undergo additional medical screening for safety.
On July 15, Vanderbilt University Medical Center announced it would recruit 1,000 volunteers to receive an experimental COVID-19 vaccine developed by Moderna Inc. in collaboration with the National Institutes of Health. Patients age 18 or older will receive two shots of either the vaccine or an inactive placebo and will be followed for two years. Contact covidvaccine@vumc.org or vaccineresearch@vumc.org for more information. VUMC is one of a number of other U.S. centers participating in nationwide Phase 3 trials with 30,000 volunteers.
By conducting trials, Berthaud said, he and other scientists will educate themselves in science and on the way people perceive the pandemic. That may help science influence public behavior.
Berthaud and Singh agree, the human race will probably have to deal with the novel coronavirus pandemic for 12-18 more months. It may take that long for a safe and effective vaccine to protect people against COVID-19. Therefore, the Meharry scientists strongly advocate use of face masks, frequent hand washing and use of sanitizing products. Both point to success in New York City where people practiced social distancing and other protective steps recommended by the Centers for Disease Control.
