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Muscular disorder treatment might provide basis for COVID-19 vaccine, researchers say

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June 10 (UPI) — University of Florida researchers on Wednesday announced plans to repurpose a gene therapy approach used to treat rare neuromuscular diseases for a potential vaccine against COVID-19.

The approach being explored at the university involves injecting an adeno-associated virus, or AAV, for the new coronavirus into people. This is essentially a gene from harmless SARS-CoV-2, the new coronavirus that causes COVID-19, that will block harmful versions of it from entering human cells, researchers said.

In the past, AAVs have been used to treat rare neuromuscular disorders, including muscular atrophy in children, the researchers said.

They said they hope to begin clinical trials of the vaccine candidate in humans later this year and remain optimistic they can use the injection to fight future strains of SARS-CoV-2 as they develop.

“This is a virus that can change very rapidly, [which] is concerning because it means any vaccine made today may be ineffective tomorrow,” Dr. Barry J. Byrne, a rare disease research and pediatrician at the school, said in a press release.

At present, at least 10 potential COVID-19 vaccines are in clinical trials, with dozens of others in development, according to the World Health Organization.

The University of Florida gene therapy vaccine can’t replicate on its own, but is potent enough to trigger a beneficial, antivirus response from the immune system, according to Byrne and his colleagues, who are working in the school’s Emerging Pathogens Institute.

Results from preclinical studies intended to determine whether the AAV vaccine can trigger virus-neutralizing antibodies against live SARS-CoV-2 are expected later this month. Early studies in animals have confirmed the vaccine starts to work quickly and remains in the system longer than many other single-dose injections.

The team is ready to assess the effectiveness and toxicology of two closely related vaccine candidates in rodents, which will pave the way for human trials, Byrne said.

He said he hopes to start a 12-month, multi-arm Phase I/II study to assess the vaccines’ single-dose safety and effectiveness in 100 adult volunteers, with an emergency-use authorization requested from the U.S. Food and Drug Administration.

The AAV approach has some potential advantages over traditional vaccine development, said Byrne, who is director of the university’s Powell Gene Therapy Center.

In addition, researchers likely won’t have to spend as much time establishing AAV’s safety — given that the effective dose for a vaccine is thousands of times less than in a genetic disease — because the approach has been evaluated in multiple clinical trials for other diseases.

Byrne and his colleagues also aim to develop a universal vaccine for future SARS-CoV-2 strains, an important consideration given that multiple mutations — changes in the virus’s genetic sequence — have been documented by scientists.

They plan to develop a library of various “spike” proteins that the coronavirus uses to invade human cells — a process that could take 18 months, according to the researchers.

While no licensed vaccines use AAV, about 25 so-called viral vector vaccines are in various stages of development around the world, Byrne said.

An AAV vaccine could be produced for only a few dollars per dose, although producing it in large may be challenging, he said.



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2 in 3 parents would send kids to school in the fall, survey finds

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About two-thirds of U.S. parents say they’ll send their kids to school again this fall, and most also support COVID-19 testing and social distancing policies for schoolchildren, a new survey finds.

Among parents, only about 12 percent said they would not send at least one of their kids to school, while 21 percent were still uncertain about their decision. Many are waiting to hear more about their schools’ plans.

Many parents said they had no choice but to send their children to school because they had to work.

For many families, a surge in COVID-19 cases would make them reconsider sending children to school, the survey found.

Most did support measures to safeguard kids against the new coronavirus.

Those measures could include fewer children on buses, daily temperature screening, alternating classroom and online learning, testing school staff and requiring staff and older kids to wear masks, researchers report.

For the report, researchers from the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, surveyed nearly 1,200 parents in Michigan, Ohio and Illinois in June.

“Families are facing a challenging decision regarding whether to send their children to school for in-person classes in the middle of the COVID-19 pandemic,” said researcher Dr. Kao-Ping Chua, a pediatrician at Michigan Medicine C.S. Mott Children’s Hospital.

“On the one hand, sending children to school could increase the risk of COVID-19 among children and family members. On the other hand, children who don’t return to in-person school may experience disruptions in their education,” Chua said. “Some families simply don’t have a choice because they need to go to work.”

According to the survey, 75 percent of parents supported daily temperature checks and testing of kids if one tested positive for COVID-19.

Over 60% supported limiting the number of kids on buses, alternating between in-person and virtual classes, staggering arrival and pick-up times, and random weekly COVID-19 testing for staff.

Half supported random weekly COVID-19 testing of kids and having children eat meals in classrooms, not in cafeterias.

Most parents supported face masks for staff and middle and high school students, but not for younger children, especially kindergarten through second grade.

There wasn’t much support for closing playgrounds and halting all extracurricular activities.

“Preferences for the number and types of measures vary among parents,” Chua said in a university news release. “But they broadly agree with the notion that schools should take steps to keep children as safe as possible.”

More information

For more on COVID-19 and schools, head to the U.S. Centers for Disease Control and Prevention.

Copyright 2020 HealthDay. All rights reserved.



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Study: Deep brain stimulation may slow Parkinson’s disease

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Data from a five-year clinical trial is adding to growing evidence that deep brain stimulation, or DBS, can slow the ravages of Parkinson’s disease.

Researchers at Vanderbilt University Medical Center in Nashville, Tenn., said that the therapy appears to curb any worsening of tremor and other symptoms, as well as lessening a patient’s need for medications.

“Parkinson’s is relentless,” senior study author Dr. David Charles, Vanderbilt professor and vice-chair of neurology, said in a medical center news release. “There’s nothing that slows down its progression.”

However, “with this pilot study, we’ve shown that if DBS is implanted early it’s likely to decrease the risk of progression, and if this is borne out in our larger study it would be a landmark achievement in the field of Parkinson’s disease,” he said.

The new study was small — just 30 patients. Between 2006 and 2009, the participants were randomly selected to receive either the optimal Parkinson’s disease drug therapy, or optimal drug therapy plus DBS.

In DBS, doctors surgically implant a pair of ultra-thin electrodes deep into the brain. The electrodes target electric pulses to the subthalamic nucleus, a small cluster of neurons. Similar to a heart pacemaker, the device is powered by a small battery implanted under the skin near the patient’s collarbone.

After five years, patients who’d received only the drug therapy had a five times higher risk of progression of “rest tremor” — a key Parkinson’s symptom — compared to those patients who’d gotten the electrode implants as well as drug therapy, the researchers reported.

What’s more, patients who got DBS needed far fewer meds going forward.

“Patients who were randomized to receive early optimal drug therapy [only] had 15-fold greater odds of needing multiple types of Parkinson’s disease medications,” study project leader Mallory Hacker, an assistant professor of neurology at the medical center, said in the news release.

The evidence of reductions in another key Parkinson’s symptom — worsening motor symptoms — did not reach statistical significance, the researchers said, although there was a trend suggesting a benefit from DBS.

Still, this study was small and the results should be considered preliminary, Charles said.

“While this is an incredibly exciting finding, patients and physicians should not change clinical practice at this time,” Charles said. “What this pilot study is most clearly telling us is that the new FDA-approved Phase III study must be done to definitively determine whether DBS slows the progress of Parkinson’s disease when implanted in the very earliest stages.”

Dr. David Weintraub directs functional neurosurgery at North Shore University Hospital in Manhasset, N.Y. Reading over the study he said that it “provides evidence that the use of DBS surgery early in the course of Parkinson’s disease can have meaningful benefits for patients compared to medication alone.”

Weintraub agreed that the findings remain preliminary. However, he said that positive results from a “larger scale, multicenter trial could potentially lead to the adoption of DBS surgery even earlier in the course of Parkinson’s disease treatment, which would be a very significant advance in the field.”

The study was published in the July issue of Neurology. It received funding from the U.S. National Institutes of Health, the Michael J. Fox Foundation for Parkinson’s Research, and Medtronic, Inc., the manufacturer of the DBS system used in the trial.

More information

Visit the Parkinson’s Foundation for more on Parkinson’s disease.

Copyright 2020 HealthDay. All rights reserved.



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Study finds differences in heart failure trends between former East, West Germany

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July 1 (UPI) — Differences in heart health between people in the eastern and western parts of Germany show a long-term effect of the Berlin Wall on the country, according to new findings presented Wednesday on HFA Discoveries.

Germany was divided in the aftermath of World War II, and different healthcare structures developed in East and West Germany. The country became unified again in 1990, but new research shows effects of the decades-long separation persist, researchers say.

From 2000 to 2017, the absolute number of hospital admissions due to heart failure throughout Germany increased continuously by nearly 94 percent — to approximately 465,000 from just under 240,000 — researchers said.

However, the increase was much higher, at 119 percent, in the region that once encompassed East Germany, compared to just over 88 percent in the region once known as West Germany, they said.

Study co-author Marcus Dörr, a professor at the University Medicine Greifswald in Germany, said differences between the two regions in prevalence of heart failure risk factors may explain the findings.

“In fact, previous research has shown that, for example, hypertension, diabetes and obesity are much more common in East than in West Germany,” Dörr said in a press release.

In addition, lingering differences in patient care, as well as in the management of healthcare systems between the two regions, still might exist, Dörr said.

In general, heart failure is the most common reason for hospital admissions in the United States, Germany and much of the world, he said.

For their research, Dörr and his colleagues analyzed data from the Federal Health Monitoring project, an annual census of routine health data in Germany, for 2000 through 2017.

Heart failure was the leading cause of disease-related hospitalization in Germany in 2017, they found.

However, heart failure hospitalization rates nearly doubled in the former East Germany — to 2.9 percent from 1.5 percent — from 2000 to 2017, while it increased to 2.2 percent from 1.4 percent in the former West Germany over the same period, the researchers said.

While the overall length of hospital stays decreased continuously over the same period, the total number of heart failure-related hospital days increased by 51 percent in East Germany, compared to 35 percent in West Germany.

In 2017, heart failure was by far the leading cause of in-hospital death across Germany, accounting for 8.2 percent of deaths, they found.

However, in the region that once was East Germany, heart disease caused 65 deaths per 100,000 inhabitants in 2017, compared to 43 deaths per 100,000 inhabitants in the former West Germany, they said.

The differences may have to do with the average age of people in East Germany — four years older than it is in the West — but the differences in heart failure-related parameters were similar after standardization, the researchers said.

Before reunification in 1990, East and West Germany had distinct healthcare systems, Dörr said. The system in East Germany was essentially run by the state, with less than 1 percent of physicians working in private practice, and there were often shortages of technical equipment, he said.

“Since 1990, both regions have the same federal healthcare system with more physicians in private practice and similar clinical care pathways” Dörr said. “More research is needed to explain the huge differences observed between East and West Germany.”



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