Tag: Experimental


Experimental coronavirus vaccines: When they will roll out, side effects and what it all means for you

CLEVELAND, Ohio — When University Hospitals needed volunteers willing to test an experimental vaccine for COVID-19, UH’s Dr. Margaret Larkins-Pettigrew signed up, and brought along her physician husband as well.

The couple learned they will undergo two injections of either the vaccine or a placebo; they won’t be told which they were given.

Over the next two years, they will undergo periodic physicals, keep track of their symptoms and turn over their medical records to trial organizers if they are hospitalized for COVID-19.

Larkins-Pettigrew said she felt an obligation, as a physician, to participate in the vaccine trial.

“This is a safe trial to be involved in,” said Larkins-Pettigrew, who is UH Edgar B. Jackson chair of Clinical Excellence & Diversity. “Science will direct us to make sure all of us are protected.”

All over the world, people like Larkins-Pettigrew are signing up to help pharmaceutical companies test prospective COVID-19 vaccines, as part of an effort to get vaccines to the public and stop the pandemic’s devastating effect.

In Ohio, Pfizer and its partner BioNTechSE, and Moderna — forerunners in the race to develop a vaccine — are conducting trials at research centers across the state to determine their safety and efficacy.

Ohio State University Wexner Medical Center is the site of a two-year, Phase 3 trial of the vaccine developed by AstraZeneca, a British-Swedish company, and the University of Oxford.

University Hospitals and the Louis Stokes Cleveland VA Medical Center are among 120 clinical investigational sites around the world that will collectively enroll up to 44,000 participants in a Phase 3 trial to test the vaccine BNT162b2, developed by Pfizer and the German company BioNTechSE.

Rapid Medical Research Inc., in Beachwood is testing the mRNA-1273 vaccine from Moderna in a two-year trial. Two sites in Cincinnati are also testing this vaccine.

How much protection will these vaccines offer? Will we need to get a coronavirus shot every year?

“These are all open questions,” said Dr. Carlos Malvestutto, assistant professor of infectious disease and co-chair of the COVID-19 Task Force, at Ohio State University Wexner Medical Center.

“The only way to answer them is through clinical trials,” Malvestutto said.

The public has questions as well, such as how these vaccines work inside the body, why some trial participants receive a placebo and how to join a trial.

Let’s get some answers.

How do these vaccines work?

All vaccines trigger the body’s immune system to mount a defense against invading illnesses. The approach taken by AstraZeneca is different from how Pfizer and Moderna are approaching the problem.

AstraZeneca’s vaccine uses a modified chimpanzee adenovirus, altered to make it harmless to humans, Malvestutto said. The adenovirus is used as a viral vector to carry a single coronavirus gene into the body. The coronavirus components of the vaccine spark an immune response against the actual coronavirus.

The vaccine does not include the whole virus and cannot cause COVID-19, Malvestutto said.

The Pfizer vaccine candidate is made up of messenger RNA coupled to a

Experimental therapy could remove need for insulin

Scientists have proposed a new therapy for type 2 diabetes. If proven effective, the therapy could help some people discontinue insulin treatment.

Scientists have proposed a new therapy for the treatment of type 2 diabetes, with a proof-of-concept study showing positive initial results. If effective, the therapy may mean that some people can stop taking insulin treatment.

The authors of the research presented their findings at UEG Week Virtual 2020, a conference organized by United European Gastroenterology, a professional nonprofit organization for specialists in digestive health.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, a person may have type 2 diabetes when their blood sugar is too high.

People gain blood sugar, or blood glucose, mainly from the food they eat. Insulin helps cells access this glucose to use as energy. However, for a person with type 2 diabetes, either their body does not make enough insulin or their cells do not respond to insulin correctly.

This then means that the glucose in their blood increases, which can lead to complications of diabetes, such as heart and kidney disease, visual impairment, and loss of sensation in the limbs. The higher the blood glucose over time, the higher the risk of these complications.

According to the Centers for Disease Control and Prevention (CDC), about 1 in 10 adults in the United States have diabetes, and 90–95% of these individuals have type 2 diabetes.

Doctors typically recommend lifestyle changes, such as being more physically active and eating a more healthful diet, to treat type 2 diabetes, as well as medications to manage a person’s blood pressure and blood glucose levels.

Insulin treatment may be necessary if a person is unable to maintain their blood sugar at normal levels. This treatment can take the form of injections, pens, pumps, or inhalers. It encourages the cells in a person’s body to absorb more blood sugar.

However, people’s perception of the side effects of insulin treatment can be quite pronounced. As a result, doctors may be less likely to prescribe insulin, and, when they do, people may not take it regularly.

Consequently, therapies that can avoid these perceived side effects may be valuable in ensuring that people keep up with their prescribed treatment and avoid risking serious health issues.

In this context, the researchers behind the present study used a novel technique that scientists first reported using in humans in 2016. Based on those preliminary results, it seemed promising.

The technique is called duodenal mucosal resurfacing (DMR). The duodenum is the first part of a person’s small intestine. DMR involves lifting the mucosal layer of the duodenal to allow the ablation of the revealed area using heated water — a process that removes the cells in the targeted area.

The researchers who developed the DMR technique were trying to replicate the positive impact that bariatric surgery (gastric bypass) has on blood sugar levels with a less invasive technique.

Studies of how bariatric surgery improves blood sugar control have concluded that there