Tomball-based facility studies new vaccine for seniors

With a goal to improve health care, a local research facility is carrying out a study for a new vaccine designed to prevent a bacterial infection primarily affecting the age 65 and older group.

Tomball-based DM Clinical Research is working with Dr. Muhammad Irfan of the Family Diagnostic Clinic on a three-year medical study to test a new vaccine for Clostridium difficile, or C. diff, community liaison Mackenzie Haley said. The mild to life-threatening bacterial infection often attacks the intestines of seniors while taking antibiotics in hospitals, she said.

There are about 453,000 cases of C. difficile diagnosed annually with 29,300 associated deaths in the U.S. per year, according to a 2011 Centers for Disease Control and Prevention study.

“It’s becoming a huge problem,” Haley said. “C. diff has been around for more than a decade. Anybody in the hospital industry knows it and knows it well. If someone comes from a hospital into a nursing home, basically they are quarantined until the infection clears up.”

With about 10 participants already in place, DM Clinical Research is seeking about 100 total patients for the clinical trial, Haley said. Through the clinical trials, seniors can often receive medications at no cost, financial reimbursement and learn new ways to be accountable for their health care, Haley said.

“One of the biggest problems I see out there in the community is people being noncompliant with their clinical care,” Haley said. “A lot of seniors live on a fixed income and can’t afford medication, so they are having to pick and choose which medication to take.”

Patients do not have to take part in the study for the full three-year duration but are encouraged to participate as long as possible, Haley said. Participants are typically seen for a few weeks regularly and then are seen once every six months to follow-up, she said.

“There’s some studies that require you to come in quite often, but this is not terribly time consuming or demanding,” Haley said.

DM Clincial Research, which serves as a study coordinator, has been carrying out the clinical study for six months with participation from patients in other countries. The study will be sent to the U.S. Food and Drug Administration for final vaccine approval. Haley said it could be three years before the vaccine is available on the market for patients if it is approved to help prevent the bacterial infection.

“Basically what it does is it protects the gut, so nothing can get through even when you are on antibiotics,” Haley said. “The great thing about it is it’s safe, effective and the only side effects are the same effects you experience from a flu shot.”

For more information on the clinical trial, visit www.dmclinicalresearch.com.