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New clinical trial studies nasal COVID-19 vaccine

New clinical trial studies nasal COVID-19 vaccine
LAST WEEK WE TOLD YOU ABOUT THE SMITHS AND THEIR DESPERATE EFFORT TO HELP THEIR SON, WHO WAS SUFFERING WITH SEVERE PEDIATRIC LONG COVID. THEIR BANKING ON A NONTRADITIONAL CLINIC IN ARKANSAS, WHICH HAS GIVEN OTHER LONG COVID KIDS THEIR LIVES BACK. BUT GETTING THERE IS NOT EASY. DYLAN SMITH, NOW 14, FELL ILL TO LONG COVID MORE THAN TWO YEARS AGO AND HIS CONDITION HAS SPIRALED DOWN. HE IS NOW BED RIDDEN WITH A FEEDING TUBE AND IN CHRONIC PAIN, BUT HIS PARENTS HAVE HOPE. FAST. FORWARD ONE YEAR FROM NOW, WHAT DO YOU ENVISION? WHAT DO YOU HOPE? OH MY GOSH, I HOPE THAT OUR SON IS RUNNING AROUND THIS HOUSE. UM, I HOPE WE’RE BACK TO A HECTIC SCHEDULE OF WATCHING HIM PLAY SOCCER JUST EVERY DAY NORMAL LIFE. HONESTLY, JUST WATCHING HIM BRUSH HIS TEETH AND WASH HIS FACE. STACY AND MIKE SMITH BELIEVE THAT IS POSSIBLE IF THEY CAN GET DYLAN TO A NONTRADITIONAL MEDICAL FACILITY IN FAYETTEVILLE, ARKANSAS CALLED THE SPIRO CLINIC. THE FOUNDER AND CEO SAYS THEY ARE SEEING GREAT SUCCESS IN TREATING PEDIATRIC LONG COVID. SO FAR, WE’VE HAD 100% SUCCESS RATE. NOW WE’VE HAD FEWER THAN TEN SEVERE LONG COVID CASES. SO IT’S NOT A BIG POOL OF PATIENTS, BUT I’M VERY EXCITED ABOUT THE POSSIBILITY THE CLINIC TREATS SEVERE PAIN DISORDERS SUCH AS COMPLEX REGIONAL PAIN SYNDROME OR CPPS. AND NOW PEDIATRIC LONG COVID 14 YEAR OLD TRISTAN KIM IS A LONG COVID PATIENT WHO HAS BEEN AT THE CLINIC FOR FIVE MONTHS. HE IS NOW ABLE TO EXERCISE ON HIS OWN, EVEN RIDE A SCOOTER. THIS WAS TRISTAN BACK IN JANUARY WHEN HE FIRST ARRIVED IN A WHEELCHAIR. MOM ASHLEY SAYS HIS SYMPTOMS WERE SO HORRIFIC HE QUESTIONED WHETHER HE WANTED TO LIVE. HIS BRAIN FELT LIKE IT WAS ON FIRE. HE HAD VISION LOSS, BLISTERING SKIN, STOMACH PAIN, NAUSEA, A FEELING LIKE HIS BODY WAS BEING CRUSHED. WE HEARD ABOUT SPIRO. WE WEREN’T SURE IT WAS THE RIGHT PLACE, BUT WE KNEW IT WAS A NEUROLOGICAL DISEASE. WE KNEW THAT. WE KNEW THAT WHAT WAS HAPPENING WAS NOT NORMAL, AND THAT A CHILD SHOULD NEVER HAVE TO BE IN THAT KIND OF PAIN. UM, A CHILD SHOULD WANT TO WAKE UP EVERY DAY AND TO NOT WANT TO DO THAT BECAUSE YOU’RE IN SO MUCH PAIN IS NOT THAT’S NOT OKAY. THE TREATMENT IS OUTPATIENT AND LASTS 14 TO 20 WEEKS. THERAPISTS USE AS MANY AS 16 DIFFERENT TECHNIQUES, ALL TREATING THE CENTRAL NERVOUS SYSTEM, DECREASING INFLAMMATION. UH, GLOBALLY, BODY WIDE, AND THEN KEEPING THE BODY VERY CALM. THE NERVOUS SYSTEM SO YOU CAN PUSH VERY HARD ON THE OTHER END AND NOT SEND THAT PATIENT INTO A STATE WHERE THEY HAVE WORSE SYMPTOMS. FOR TRISTAN’S FAMILY, HIS PROGRESS IN FIVE MONTHS IS NOTHING SHORT OF REMARKABLE. ALL IT IS MAY AND HE IS SIGNING IN EVERY DAY AT A ZERO PAIN LEVEL. THIS CHILD HAS ZERO PAIN COMING FROM A CHILD WHO NO LONGER WANTED TO WAKE UP ANYMORE BECAUSE HE WAS SO SCARED TO FACE THE DAY WITH ALL THE PAIN AND IT IT’S MIND BLOWING. IT TRULY IS. SO HE’S GONE FROM SURVIVAL TO PLAYING WITH HIS BROTHERS AGAIN. HE’S HORSING AROUND AGAIN. HE’S SWIMMING IN A POOL. HE’S DOING THINGS THAT WE COULDN’T EVEN IMAGINE HIM DOING FIVE MONTHS AGO. SO WHAT’S THE CATCH? WELL, BECAUSE THE CLINIC IS NOT MAINSTREAM MEDICINE, IT IS NOT COVERED BY INSURANCE AND THE PRICE TAG IS HIGH. STACY ESTIMATES IT WILL COST THEM ABOUT $100,000 FOR THE TREATMENT, AND THE COST OF TEMPORARILY RELOCATING TO ARKANSAS. THE SMITHS ARE GRATEFUL FOR HELP AND SUPPORT FROM THEIR COMMUNITY, BUT THE COST REMAINS A DIFFICULT HURDLE TO OVERCOME, ESPECIALLY SINCE STACY, A TEACHER, HAS BEEN UNABLE TO WORK FULL TIME, IF AT ALL, WHILE CARING FOR DYLAN. WE JUST FOUND OUT ABOUT THE CLINIC IN MARCH AND HIS START DATE IS IN JUNE, SO WE HAVE A SHORT AMOUNT OF TIME TO RAISE A LARGE AMOUNT OF MONEY. THERE’S NOTHING THAT, UM, THAT WE CAN, UH, GET FROM FROM OUR GOVERNMENT OR SOCIAL SECURITY, WHICH IS UNFORTUNATE. DYLAN DOESN’T QUALIFY. AND EVEN WITH SOME OF THE GRANTS, THEY DON’T UNDERSTAND OR RECOGNIZE THIS TYPE OF TREATMENT. BUT STACY AND MIKE WILL NOT GIVE UP UNTIL THEY GET DYLAN TO THE SPYRO CLINIC. IN FACT, THEY PLAN TO TAKE THE WHOLE FAMILY. THREE DOGS INCLUDED, TO FAYETTEVILLE. WE’LL FIGURE IT OUT. WE JUST DON’T HAVE A CHOICE. SO YOU ARE DETERMINED OR YOU DON’T HAVE A CHOICE. I SAID. I WILL LIVE IN A TENT IF I HAVE TO. YEAH, WE WE WILL. UM, WE WILL GET HIM THE TREATMENT. YEAH. WE HAVE TO SAVE HIS LIFE. IF YOU WOULD LIKE TO HELP THE SMITH FAMILY, VISIT THE WEBSITE HOWARD. DYLAN.COM. THERE IS A LINK ON OUR WEBSITE WE HOPE TO FOLLOW DYLAN’S STORY AS HIS FAMILY FIGHTS TO GIVE THEIR CHILD HIS LIFE BACK.
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New clinical trial studies nasal COVID-19 vaccine
A trial sponsored by the National Institutes of Health (NIH) is recruiting participants to study a nasal COVID-19 vaccine. The candidate vaccine aims to provide enhanced protection against variants of SARS-CoV-2, the virus that causes COVID-19. One goal of the trial is to evaluate the vaccine's ability to produce local immunity in cells lining the nose and respiratory tract and lower the virus's potential to spread.Related video above: Family fighting to pay for son's unique long COVID treatmentCurrent COVID-19 vaccines are delivered by injection to create antibodies that circulate through the blood and cause a strong immune response. Despite helping recipients avoid serious illness, the vaccine is far from perfect. "While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease," said Jeanne M. Marrazzo, director of the National Institute of Allergy and Infectious Diseases (NIAID). "With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission," Marrazzo said.The candidate vaccine in the clinical trial, MPV/S-2P, uses murine pneumonia virus to deliver a stabilized version of a spike protein that SARS-CoV-2 uses to attach to human cells. By administering it intranasally, researchers aim to have the vaccine produce local immunity in the nose and throat, where infection from respiratory viruses often starts."What we realized is that systemic vaccination — when we inject it and it goes through the body to build up immunity — is not as effective as generating a mucosal, or lining cell, immunity in the nose or in the lungs," Dr. Reynold Panettieri, a professor of medicine at the Robert Wood Johnson Medical School at Rutgers University, told ABC News. "And so, when people can inhale the protein, in this case, the spike protein ... actually builds up an immune response that's much more robust than that when it is injected."Following pre-clinical non-human primate studies by scientists from NIAID's Laboratory of Infectious Diseases, researchers believe mucosal immunity and improved systemic immune responses will help prevent infection and transmission.The trial will be conducted as part of Project NextGen, led by the Biomedical Advanced Research and Development Authority and NIAID. The Phase 1 trial is currently enrolling healthy adults between the ages of 18 and 64 who meet the eligibility criteria. Trial sites are located in Texas, Georgia and New York.

A trial sponsored by the National Institutes of Health (NIH) is recruiting participants to study a nasal COVID-19 vaccine. The candidate vaccine aims to provide enhanced protection against variants of SARS-CoV-2, the virus that causes COVID-19. One goal of the trial is to evaluate the vaccine's ability to produce local immunity in cells lining the nose and respiratory tract and lower the virus's potential to spread.

Related video above: Family fighting to pay for son's unique long COVID treatment

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Current COVID-19 vaccines are delivered by injection to create antibodies that circulate through the blood and cause a strong immune response. Despite helping recipients avoid serious illness, the vaccine is far from perfect. "While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease," said Jeanne M. Marrazzo, director of the National Institute of Allergy and Infectious Diseases (NIAID).

"With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission," Marrazzo said.

The candidate vaccine in the clinical trial, MPV/S-2P, uses murine pneumonia virus to deliver a stabilized version of a spike protein that SARS-CoV-2 uses to attach to human cells. By administering it intranasally, researchers aim to have the vaccine produce local immunity in the nose and throat, where infection from respiratory viruses often starts.

"What we realized is that systemic vaccination — when we inject it and it goes through the body to build up immunity — is not as effective as generating a mucosal, or lining cell, immunity in the nose or in the lungs," Dr. Reynold Panettieri, a professor of medicine at the Robert Wood Johnson Medical School at Rutgers University, told ABC News. "And so, when people can inhale the protein, in this case, the spike protein ... [the body] actually builds up an immune response that's much more robust than that when it is injected."

Following pre-clinical non-human primate studies by scientists from NIAID's Laboratory of Infectious Diseases, researchers believe mucosal immunity and improved systemic immune responses will help prevent infection and transmission.

The trial will be conducted as part of Project NextGen, led by the Biomedical Advanced Research and Development Authority and NIAID. The Phase 1 trial is currently enrolling healthy adults between the ages of 18 and 64 who meet the eligibility criteria. Trial sites are located in Texas, Georgia and New York.