PINEHURST — FirstHealth of the Carolinas has become the first site in the state to enroll a patient in a multicenter international clinical trial to determine if giving expecting mothers an investigational vaccine for respiratory syncytial virus (RSV) could help protect their babies from RSV after they are born.
The trial is called MATISSE and is sponsored by Pfizer. John Byron, M.D., obstetrician and gynecologist with Southern Pines Women’s Health Center, a FirstHealth Clinic, is principal investigator for the trial, and Christoph Diasio, M.D., pediatrician with Sandhills Pediatrics, is sub investigator.
Respiratory syncytial virus, RSV for short, is known to cause common illnesses of the airways. It is the most common cause of bronchiolitis (inflammation of the small airways) and pneumonia (infection of the lungs) in children under 12 months.
John Byron, M.D.
“For most young children, RSV is often mild and causes wheezing, coughing, sneezing and runny nose,” said Dr. Diasio. “However, for some babies, RSV can be very serious, and lead to trouble eating or breathing and hospitalization. This is especially true for infants who are premature or have heart or lung problems.”
RSV is contagious and spreads from contact with a person who has it, often by sneezing, coughing or kissing. It can also be spread by touching contaminated surfaces, like doorknobs or blankets, and then touching your mouth, nose or eyes. RSV commonly occurs in the fall, winter, or early spring.
“Currently, there is no curative treatment for RSV bronchiolitis, we mainly have supportive care, which is why we’re especially excited to participate in the MATISSE study to work to develop a maternal vaccine to potentially prevent babies from getting very sick from RSV.”
Dr. Byron has now enrolled five of his patients who are expecting mothers in the trial.
“Upon enrollment in the trial, expecting mothers are provided a mobile app to download on their smartphone or they are provided a mobile device to use to communicate with FirstHealth’s clinical study coordinators,” said Dr. Byron. “They use the app to notify the study coordinators once they have delivered their baby and then check in routinely until their child reaches two years of age.”
Christoph Diasio, M.D.
The children are followed by Dr. Diasio and the clinicians at Sandhills Pediatrics for routine care. The only additional testing requirement may be necessary when the child is seen for a sick visit.
“If a child who is participating in the trial comes in for a sick visit during the first two years, we will collect an additional nasal swab to be tested and analyzed by the clinical study coordinators to determine if the runny nose was from RSV or another virus,” said Dr. Diasio.
Parents participating in the study will have the option to be trained to collect the nasal swabs at home. The study also includes telehealth visits.
To take part in this study, participants must be:
- Between 18 and 49 years old
- Healthy and expecting a single healthy baby
- Between 24 to 36 weeks pregnant when you receive the study vaccine
- Not planning on having your baby at home
- Willing and able to attend study visits and follow instructions from your study team
For more information about the MATISSE trial at FirstHealth, please call (910) 715-2200.