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Norovirus vaccine trial underway in Tucson as cases surge nationwide

Quality of Life Research Center looking for participants 70 years old and up to help find vaccine
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TUCSON, Ariz. (KGUN) — As norovirus cases climb across the country this season, the Quality of Life Research Center in Tucson is playing a crucial role in the global effort to combat the virus.

Known for causing severe gastrointestinal symptoms, norovirus affects between 19 and 21 million people annually, according to the CDC, and is responsible for about half of all food-borne illnesses each year.

The virus is typically spread through an infected person handling food, a primary reason why the norovirus has thrived in group settings like assisted living facilities and cruises.

The virus can lead to significant health and economic consequences.

Dr. John McGettigan, Physician and CEO of the Quality of Life Research Center, is leading a phase three clinical trial to develop a vaccine against the virus. He says the biggest danger is through dehydration caused by vomiting and diarrhea, two of the primary symptoms of norovirus.

Around 900 people each day die from the norovirus, according to the CDC. McGettigan says that the virus is especially dangerous for older adults.

“As we get older, we’re more fragile and don’t have the reserves we used to have,” he said. “Younger people can handle it better. But unfortunately, when we’re older, we likely have other health concerns that prevent us from bouncing back.”

The trial began in October and initially enrolled participants aged 18 to 59 and 60 to 69.

Now, the center is actively seeking 100 participants aged 70 and older to join the next phase of the study.

“People who help in research are medical heroes and heroines,” McGettigan said. “Because, without them, nothing is going to change.”

The current trial is in phase three, the final step before potential FDA approval, but McGettigan says the vaccine is likely at least two years away.

Participants in the trial will have blood drawn every six months over two years and will be compensated for their time.

“It’s a very easy study for people,” McGettigan said. “It’s basically you get a shot similar to what I’d call a flu shot in terms of symptoms, which most people get very little. Some people will develop soreness that will last for a day or two.”

Following the injection, participants are asked to monitor their symptoms for adverse effects for seven days. This is done by smartphone, the study provides if a participant lacks one.

Participants are monitored for two years to see if they develop acute gastroenteritis. Six physical visits to the facility are also required to draw blood.

McGettigan says that two participants have already developed the virus, although it’s unknown whether they received the vaccine or the placebo.

Dr. McGettigan expressed optimism about the potential breakthrough, noting that phase three status indicates a strong likelihood of eventual approval.

This isn’t the first time McGettigan has battled a global virus, as he also ran clinical trials that led to the COVID-19 vaccine. However, he says this time is very different.

“We don’t have the six-foot distancing, we don’t have the masks,” he said. “It’s not that kind of a problem.”

Typical norovirus symptoms last for one to three days, although McGettigan says that the virus can shed for longer periods in some cases, where the virus can still spread.

McGettigan advises wiping down surfaces with a bleach-based solution and washing hands with soap and water for those infected. He cautions that alcohol-based hand sanitizer is ineffective against the virus.

For those suffering from the virus, Dr. McGettigan suggests eating chicken soup, drinking tea and consuming other substances that are “easy on the stomach.”

Those interested in participating in the clinical trial can call 520-733-2250 to start the process. You can find more information about the study on the Quality of Life Research Center website.

In addition to the norovirus study, the center is always looking for participants for other clinical trials.