Clinical Trials

Study focuses on vaccine to prevent deadly infection

Although retired from her jewelry business, Mary Winstead, 74, returns to her studio from time to time to create pieces for her favorite galleries. About two years ago, however, she had an issue with her back and needed surgery. She never expected what would go with it.

Photo by Jordan Pysz.

Mary (right) and her partner Ann Allen, spend some time in their studio making jewelry.

When Mary was preparing for her surgery, her primary care physician made an unusual suggestion. Her physician, Gigi C. Lefebvre, MD, told her about a clinical trial of a vaccine to prevent a potentially deadly infection that can affect older, hospitalized individuals. She thought it would benefit Mary to enroll.
“This study focuses on one of the most dangerous infections you can get in a hospital,” confirms Mary. “Since my surgery was set up two months in advance, I knew I was going to be in the hospital. My doctor said I was a prime candidate for the trial. I decided to go ahead and become a study subject.”
The clinical trial, which is ongoing, is testing the safety and efficacy of a vaccine to prevent infection by a bacterium called Clostridium difficile, or C. diff. The trial is being conducted at Meridien Research, an independent medical research clinic with six locations throughout Central Florida.
Dr. Lefebvre, Mary’s physician, is leading the study.
“C. diff causes an infection of the colon,” explains Dr. Lefebvre. “This can result in profuse diarrhea and extreme inflammation of the bowel, making patients unable to absorb fluid and electrolytes. As a result, they can become dehydrated and malnourished, and in certain cases, they can die.”
The C. diff trial is a double-blind study. The participants are divided into two groups: One is given the test vaccine, and the other is given a placebo. Neither the researchers nor the participants know who is getting vaccine and who is getting placebo.
“I was given three injections a couple of weeks apart before I went into surgery,” states Mary. “It’s possible I didn’t get the actual vaccine, but I was willing to try and see if it would help me and could then help someone else.
“A few friends have family members who’ve gone into the hospital, gotten
C. diff and nearly died from it. Your body is already stressed, especially if you’ve had a major operation, and then if you get this infection, you’re lucky if you can survive it.”
As part of her participation in the clinical trial, Mary first received the injections. Then, the staff at Meridien Research carefully monitored her for any symptoms of C. diff infection, such as diarrhea, or any side effects from the injections.
“Initially, I went to Meridien Research and got evaluated in person once every six months,” she offers. “Now, I get a follow-up phone call every two weeks. In the two years I’ve been in the study, I’ve had no negative results.
“During that time, I was in Europe for ten weeks. It was a different environment as far as food and water, but I didn’t get sick. I still had to report in, and I was able to email the staff and say, I’m fine. I don’t know if I have the vaccine in me, but I haven’t been ill since I started in the study.”

Public Health Crisis

C. diff infection is common in people who have been hospitalized, spent time in nursing homes or have taken antibiotics. The US Centers for Disease Control and Prevention reports that C. diff causes nearly half a million infections each year and more than 29,000 deaths. It’s become a public health crisis, due in part to the overuse of antibiotics.
“Infection with C. diff is common in people who take antibiotics to treat other conditions, such as pneumonia or a skin or bladder infection,” notes Dr. Lefebvre. “The antibiotics kill the bad bacteria, but also kill healthy bacteria that live in the bowel. C. diff also lives in the bowel and is very resistant to typical antibiotics.
“Normally, healthy bacteria keep
C. diff in check. Taking antibiotics that kill those healthy bacteria creates an imbalance in the bowel flora and an overgrowth of C. diff. When C. diff grows unchecked, the result is infection and illness.”
The goal of the current clinical trial is to show that the vaccine being tested prevents this infection from developing. To prove it, Meridien Research is enrolling people who are at high risk for C. diff infection.
“In this study, unlike many clinical trials, we’re looking for people who tend to be sicker than the average person,” expounds Dr. Lefebvre. “We want individuals who have been in the hospital.
“Ideally, we’d like those who’ve had two hospitalizations and a course of antibiotics in the past year, but if they’ve had additional hospitalizations, that’s okay. We want people on the sicker side of the spectrum because they’re more susceptible to contracting C. diff.
“Anyone can get a C. diff infection, but the more times a person is hospitalized or has been given antibiotics, the greater the risk.”
C. diff is an infection physicians would rather prevent than treat. While younger, healthier patients may respond to some antibiotic, older patients are at risk for serious complications. Elderly people may not survive this infection, even if hospitalized.
The current vaccine has been under study since 2010, and some of the data have been revealed to the FDA. Some researchers are now studying appropriate dosing and regimen for the vaccine. Dr. Lefebvre stresses there’s no guarantee people entering the study will get the actual vaccine.
“There’s a fifty percent chance you will receive the vaccine and a fifty percent chance you’ll get the placebo,” she emphasizes. “However, if you don’t participate in a trial, you have a one hundred percent chance of placebo. There are no other vaccines out there, and there’s no other way of preventing C. diff infections.
“So far, the study results are looking good, but right now, we can’t promise the vaccine is totally effective. That’s what clinical trials are for.”

Dual Motivation

Mary received her trial injections before she was hospitalized for her back surgery. Whether she got vaccine or placebo, she doesn’t know. She does know she didn’t get C. diff.
“My surgery was a success, and I was in the hospital for eight days,” relates Mary. “I was in a situation in which I could have contracted this infection, but I didn’t, and I feel very lucky.”
Everyone who participates in a clinical trial at Meridien Research has his or her own motivation for becoming involved in investigating a new device or treatment. Mary says she had two main reasons for participating in the C. diff vaccine study.
“My first motivation was to do everything I possibly could to protect myself from getting C. diff, then to follow through with it if, in fact, I got the vaccine. If I give this information to the Meridien Research staff, then they can find out whether this vaccine really works, and that can help someone else.”

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    • Meridien Research

      Meridien Research has been offering medical research to residents of the Tampa Bay area since 2000. With six privately-owned clinical trial facilities in St. Petersburg, Tampa, Maitland, Brooksville, Bradenton and Lakeland, Florida, M... Read More

    • Gigi C. Lefebvre, MD

      Gigi C. Lefebvre, MD, is board certified by the American Board of Family Practice. She completed her undergraduate education, earning a Bachelor of Science degree in Biochemistry, at Louisiana State University in Baton Rouge. She then earned h... Read More