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READYING FOR TESTING — As the coronavirus pandemic spreads over the world, Accel Clinical Research in DeLand is preparing to conduct human tests of vaccines and treatments for the deadly disease. The head of Accel Clinical Research, Dr. Bruce Rankin, center, poses with members of his team. From left are Crystal Paccione, certified clinical research coordinator; Jennifer Dittman, site manager; Rankin, medical director and principal investigator of Accel Clinical Research; Lora Parahovnik, senior clinical operations consultant; and Christina Dolan, vice president of marketing.

Dr. Bruce Rankin is a family doctor with a passion for medical research.

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Dr. Bruce Rankin

Rankin and his firm, Accel Clinical Research in DeLand, have been involved in researching ways to prevent, treat and possibly cure a variety of illnesses and medical conditions, including AIDS, Alzheimer’s disease, Parkinson’s disease, back pain, shingles, swine flu, anthrax, meningitis, tetanus and yellow fever.

Now that coronavirus is a top public-health concern, Rankin said he and Accel are ready to assist in testing vaccines to prevent the spread of the pandemic.

A general practitioner and owner of Family Practice of West Volusia, Rankin also serves as a physician for Stetson University sports teams.

The Beacon asked Rankin about the role his company might play in controlling COVID-19.

The Beacon: What is the coronavirus, and what makes it different from other viruses?

Dr. Bruce Rankin: “Coronavirus is like the cold virus. It is a different virus than influenza.

“It is like the virus of the common cold, but it seems to be much more severe in the elderly and people with immune-system weaknesses. [The virus] is now known as SARS-CoV-2, since it resembles the SARS [Severe Acute Respiratory Syndrome] type of virus.”

The Beacon: What do people need to know about treatment for the coronavirus?

Dr. Rankin: “People are wanting to know why we don’t already have a treatment. People wonder why we can’t have the vaccine. We have to make sure the vaccine works, and it is safe to give.

“The answer is because this is a new strain of this virus, and human immune systems have not been exposed to the form of virus before. It is new to our immune systems when we see it.

“The way a vaccine works is to expose our immune systems to a form of the virus, like particles of the virus, to activate the immune system but not cause the disease. This way, when our immune system ‘sees’ the same particles of the real virus later, it is ready to respond much faster due to the immune system’s ‘memory cells.’

“When we do a vaccine, there are particles of the virus in the vaccine. The vaccines are changed to let your immune system ‘see’ something foreign and then have a response to the particle of the virus to create the antibody. The memory cells in the system are the most important part of the immune system.”

The Beacon: Understanding that a vaccine is supposed to prevent a disease and an antiviral is supposed to treat the disease when its symptoms appear, would you describe the testing of the vaccine or treatment that Accel Research will conduct?

Dr. Rankin: “At this site here in DeLand, we’re working on human testing for treatment.

“Once a new investigational product is produced in the lab and [once it] goes through animal testing, it is sent to research sites like ours all through the country, to be tested in humans for effectiveness. The [treatment] must show its effectiveness in treating or reducing that disease, and its safety for human use.

“All scientific medical trials for drug and vaccine development go through the same process, and they are regulated in this country by the FDA [Food and Drug Administration]. We adhere to strict guidelines for safety and quality of research data reporting for any investigational product we are testing.

“We need to test on small numbers of people to check for safety and effectiveness before it can be approved for millions of people for widespread treatment.”

The Beacon: Coronavirus, we are told, is a very contagious disease, spread by tiny droplets of liquid such as saliva in coughing or sneezing. How long can the coronavirus survive outside an infected person?

Dr. Rankin: “It can survive on an inanimate surface like metal or fabric for hours to several days.”

The Beacon: How may people better understand viral infections, as opposed to bacterial infections?

Dr. Rankin: “The virus has to have a host cell to reproduce and to move to body fluids like saliva and blood to spread. Viruses can also mutate as they reproduce in a host. So, our bodies’ own immune systems must ramp up to create new antibodies to fight this new form of virus.”

“[For example,] the mononucleosis virus is the Epstein-Barr virus. Once our immune system encounters this virus, usually as an adolescent, we have lifetime immunity to another EBV infection.”

The Beacon: How long will it take for the vaccine, if the clinical tests are successful, to become available for the population at large?

Dr. Rankin: “These trials can take several years, but I’m sure we can fast-track this for 12 to 18 months.

“For example, if one of the existing antivirals that currently have already been tested and shown safe in humans already, the FDA may allow for quick, limited studies to get it approved for another indication. If the Ebola vaccine we now already have and has been previously tested for safety and shown safe in humans now helps COVID-19, the FDA may grant its use for COVID-19 after a short time of clinical trials.”

The Beacon: How long will it be before the pandemic subsides?

Dr. Rankin: “Most of these viruses do tend to come seasonally. It is hoped that this will be seasonal. Hopefully, it will go dormant and be less active, and we’ll have an opportunity to develop a vaccine and stop this pandemic.”

The Beacon: What do you tell people who fear that vaccines may have dangerous side effects, such as the 1970s flu vaccine that caused Guillain-Barré syndrome and left a few people paralyzed?

Dr. Rankin: “The development of vaccines now is totally different from the ‘70s, and side effects are extremely rare with today’s vaccines. I don’t want people to avoid vaccines due to low risk and fear of taking a vaccine.”

The Beacon: When will Accel begin testing COVID-19 vaccines or treatment?

Dr. Rankin: “The tests may [involve] hydroxychloroquine and a new drug called remdesivir. I think it is going to be sooner rather than later.

“We are ready at Accel to test any treatment or vaccine that enters human testing. For a viral treatment with a medication, we would be screening for patients diagnosed with the disease and start acute viral infection treatment.

“When a vaccine is developed and ready for human testing, we would be screening people who are healthy and without current or previous viral infection with COVID-19. Testing a treatment for active disease research is handled differently than testing for a vaccine research for the same infection.”

The Beacon: Is it possible that people may be lulled into a false sense of security by taking a coronavirus test and getting a negative finding?

Dr. Rankin: “That’s very true. You could be tested and then get it [the disease] the next day.”

The Beacon: A new study in Great Britain concluded that the loss of taste and smell may be symptomatic of coronavirus. Is this likely?

Dr. Rankin: “Our taste and smell are part of the respiratory system, so it’s possible.”

The Beacon: What advice are you giving to your patients and anyone else who asks about how to prevent coming down with coronavirus?

Dr. Rankin: “Hand-washing, social distancing. If you show signs [such as coughing, sneezing and difficulty in breathing], get it checked.”