ST. LOUIS -- Supported by the National Institutes of Health (NIH), Saint Louis University's Center for Vaccine Development is studying two influenza vaccines in breastfeeding mothers.
|Sharon Frey, M.D., is the trial's principal investigator.|
Researchers will compare two seasonal flu vaccines that are licensed by the U.S. Food and Drug Administration: Fluzone®, which is a shot containing inactivated flu virus, and FluMist®, which is a nasal spray containing live flu virus that has been weakened and cannot cause influenza, in mothers who are breastfeeding. Mothers will receive either a flu shot or nasal spray flu vaccine.
The findings could reveal whether moms who breastfeed pass to their babies immunity to influenza through their milk. While babies younger than six months are not old enough to get an influenza vaccine, the highest rate of flu illness is seen in young infants.
"In some winters, 1 percent of babies younger than six months are hospitalized with influenza," said Sharon Frey, M.D., clinical director of SLU's Center for Vaccine Development and principal investigator. "Both of the vaccines we are studying have been used for many years in adults. While flu shots are routinely recommended for pregnant women, there is not a lot of documented experience concerning flu vaccines in breastfeeding mothers."
Researchers will study the safety of the two vaccines for mothers and babies when they are given to breastfeeding women. They will compare levels of antibodies that protect against influenza infection in mothers' breast milk and blood after breastfeeding moms have been vaccinated. They also will see if the weakened virus from FluMist is found in breast milk.
The trial will enroll up to 240 healthy new moms who delivered babies between 28 and 120 days from the start of their participation in the study, and plan to breast-feed for at least four weeks. Approximately 50 women and their babies are expected to participate in this study at Saint Louis University's Center for Vaccine Development, one of eight Vaccine and Treatment Evaluation Units funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
The trial also is being conducted at Cincinnati Children's Hospital Medical Center, Emory Children's Center in Atlanta; Duke University Medical Center in Durham, N.C.; and Group Health Research Institute in Seattle, Wash.
For further information, visit http://www.clinicaltrials.gov/ct2/show/NCT01181323. To learn more about vaccine research being conducted at Saint Louis University, call 314-977-6333 or email firstname.lastname@example.org.
On the forefront of research in fighting and preventing infectious diseases, Saint Louis University has received federal funding as a Vaccine Treatment and Evaluation Unit for two decades. One of eight NIAID-funded vaccine research centers, Saint Louis University evaluates new and improved vaccines for diseases such as influenza and novel ways of delivering them.