Ebert Family Clinic to participate in pneumococcal vaccination trial
FRISCO — Throughout her 40-year career as a pediatrician, Dr. Christine Ebert-Santos has seen the evolution of treatment for pneumococcal meningitis in children. Now, she will be part of a Phase III trial for an enhanced vaccination for the disease.
Ebert-Santos, who owns Ebert Family Clinic in Frisco, remembers performing spinal taps, IVs and intensive care unit care on patients with the disease. In 2000, doctors developed the pneumococcal vaccine, which gives the patient antibodies to fight bacteria that cause a variety of diseases such as meningitis and pneumonia, reducing the prevalence of those diseases among children.
“Since this vaccine was introduced in 2000 … not only did we stop seeing these very sick children, but also the grandparents no longer die of this pneumonia because the grandkids aren’t carrying this bacteria,” Ebert-Santos said.
Now, Ebert-Santos is directly involved in the third iteration of the pneumococcal vaccine, which will enhance the vaccine’s ability to protect against diseases caused by the bacteria. The Ebert Family Clinic — along with clinics across North America, Latin America and Europe — will be part of the Phase III trial of the new vaccine, which is being produced by Pfizer.
This is the third time the clinic has participated in a vaccination trial, and Ebert-Santos said she’s “stoked” about it. On Tuesday, Aug. 11, the clinic met with Kasey Stephenson, a clinical research associate with Pfizer, to be trained on the administration of the new vaccine.
“I’m here to just check to make sure the site is good to go and make sure it’s activated,” Stephenson said. “Really, the main point is to train the staff on how to conduct the study and go over all of the systems that we use.”
Stephenson said Pfizer chooses the clinics that participate in the study by looking at whether they have time to do the study, if they are available to recruit patients and if they have doctor-patient relationships that build trust.
Starting Monday, Aug. 17, Ebert-Santos will be offering the vaccine to children who are 42-98 days old. Those patients then will receive the vaccine three more times — when they are 4 months, 6 months and 1 year old.
Stephenson said patients are eligible for the vaccine if they’ve never received a pneumococcal vaccine before, they were born at 34 or more weeks of gestation, and they are a healthy infant.
The goal of the phase is to determine the efficacy of the treatment, said Annie Schertzer, director of Optimed Research, which acts as a liaison between the clinic and Pfizer.
In Phase I, researchers tested the vaccine on a small number of healthy subjects to observe the response in their blood and the development of antibodies. In Phase II, researchers look at the efficacy of the treatment on a smaller scale. In Phase III, the trial is expanded to test about 3,000 patients.
“They’re now able to look at a larger population and then the trials can last for several years,” Schertzer said.
The trial that will be performed at the clinic in Frisco will last about two years, Ebert-Santos said. The clinic’s primary role will be to recruit families who are interested in being part of the trial, administer the vaccine and monitor the patients’ health.
The main difference between the new vaccine and the one that doctors currently use on patients has to do with serotypes, or the strain of the microorganisms in the bacteria. The first iteration of the vaccine, which was released in 2000, protected against seven serotypes. In 2010, the Food and Drug Administration approved an enhanced vaccine that covered 13 serotypes. The vaccine in the trial covers 20 serotypes.
Ebert-Santos said that while this will be a trial for the new vaccine, patients shouldn’t be worried about potential side effects. She’s never seen anything to suggest patients suffer from major side effects from the pneumococcal vaccine.
“I’ve never had a phone call or an ER visit or a clinic visit after-hours for a side effect of this vaccine in 20 years,” she said. “I’ve never seen anything on social media or professional literature about a side effect of the vaccine. Of course, any vaccine can cause fever and fuzziness, so we always inform parents about those possible side effects.”
Families who are interested in their infant participating in the trail can contact the Ebert Family Clinic by calling 970-279-3114 or visiting EbertFamilyClinic.com.
Support Local Journalism
Support Local Journalism
As a Summit Daily News reader, you make our work possible.
Now more than ever, your financial support is critical to help us keep our communities informed about the evolving coronavirus pandemic and the impact it is having on our residents and businesses. Every contribution, no matter the size, will make a difference.
Your donation will be used exclusively to support quality, local journalism.
Start a dialogue, stay on topic and be civil.
If you don't follow the rules, your comment may be deleted.
User Legend: Moderator Trusted User