The US Food and Drug Administration (FDA) has approved the vaccine Rotarix®, a vaccine developed and first tested by Cincinnati Children’s researchers, for the prevention of rotavirus gastroenteritis in infants.
Richard Ward, PhD, a Cincinnati Children’s researcher in the Division of Infectious Diseases, originally isolated the human rotavirus strain in 1988 and with the help of David Bernstein, MD, developed it into a live, orally deliverable vaccine candidate.
Rotarix, marketed by GlaxoSmithKline, was first licensed in Mexico in 2004. Since then, it has been licensed in more than 100 countries, including Brazil, Panama, Thailand and the European Union.
The FDA’s US approval was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants.
“Rotarix was created to imitate natural infection and to defend against rotavirus gastroenteritis,” says Dr. Bernstein, director of the Division of Infectious Diseases at Cincinnati Children’s. “Regardless of the infecting serotype, studies show that naturally occurring rotavirus infection protects against moderate to severe rotavirus gastroenteritis.”
Rotarix will be available commercially in the United States in the second half of 2008.
The jaundice chip is now directly available to physicians around the world. Patients’ blood samples can be sent directly to the Cincinnati Children’s Molecular Genetics Laboratory in the division of Human Genetics, a CLIA- and CAP-certified clinical diagnostic laboratory.
Diagnosing jaundice by means of the gene chip was developed by Cincinnati Children’s pediatric gastroenterologist Jorge Bezerra, MD, and reported in the January 2007 issue of Gastroenterology.
The chip screens for the five most common genetic defects in children with inherited causes of jaundice. These five gene defects represent about half of all pediatric chronic liver disease cases.
The chip gives a precise diagnosis with just a blood sample, eliminating the need for extensive or invasive testing, and making it possible for doctors to better tailor treatment based on findings.
For more information, call 513-636-4474 or email moleculargenetics@cchmc.org.
Cincinnati Children’s has been awarded a four-year, $3.9 million grant to bridge the gap between scientific research and the clinical practice of pediatric therapeutics.
The grant, from the Agency for Healthcare Research and Quality (AHRQ), will make Cincinnati Children’s one of 14 national Centers for Education and Research in Therapeutics (CERT) that operate in cooperation with the AHRQ, part of the US Department of Health and Human Services. The program at Cincinnati Children’s will be the only one focused on children and pediatric medicine. Carole Lannon, MD, co-director of the Center for Health Care Quality, will be principal investigator of the CERT at Cincinnati Children’s.
As part of its CERT designation, Cincinnati Children’s will undertake four pilot projects to develop evidence-based research and education in effective therapeutics and patient safety.
“We want to learn what treatments are most effective and how we can use them to improve health outcomes and promote safety for children,” says Dr. Lannon.
Sirolimus, a drug that helps prevent transplant rejection, may reduce the need for surgery for patients with tuberous sclerosis complex (TSC), a genetic disorder that causes benign tumors in multiple body systems.
Investigators from Cincinnati Children’s and the University of Cincinnati College of Medicine reported the phase I/II proof-of-concept trial in The New England Journal of Medicine in January.
Many patients with TSC develop renal lesions, called angiomyolipomata, that can destroy the kidney and cause renal failure. One year of treatment with sirolimus nearly halved the angiomyolipoma volume.
Women with TSC, and sometimes those without, can also experience a cystic lung disease called lymphangioleiomyomatosis (LAM), often requiring lung transplantation. Lung function improved in women with LAM in the study.
“A drug that maintains or shrinks tumor size may reduce the need for surgery to treat angiomyolipoma,” says John Bissler, MD, lead study author and a physician/researcher in the Division of Nephrology and Hypertension at Cincinnati Children’s. Both TSC and LAM are associated with gene mutations that activate mTOR, a protein that controls cell growth. Sirolimus inhibits mTOR signaling, researchers say.
Despite limitations noted in the study, researchers are optimistic about the drug’s potential. Additional trials will further define the risks and benefits of mTOR inhibitors in patients with LAM and TSC.
When colleagues call to ask advice about complicated colorectal cases, the surgeons in the Colorectal Center at Cincinnati Children’s offer them much more.
“I’ll say, ‘Why don’t you bring your patient here, get credentialed for the day and do the case here with us,’” says Marc Levitt, MD, co-director of the center.
The center’s Visiting Surgeons and Nurses Program allows physicians and nurses to accompany their patients to Cincinnati Children’s and work alongside the surgeons.
One of the program’s biggest advantages is that the Ohio medical board and Cincinnati Children’s gives surgeons from the United States credentials for a day so that they can actually participate in their patient’s surgery. Physicians from outside the United States can accompany their patients and observe procedures; the program regularly hosts colorectal surgeons and nurses from around the world.
It’s a collaboration that benefits everyone involved, says Dr. Levitt, who credits the infrastructure at Cincinnati Children’s for the program’s success.
“The equipment, facilities, nurses and coordinators make this program possible,” he says. “Combined with the credentialing opportunity, it makes this program something I could not see being anywhere else.”
