14 DAY TRIAL // Vaccination against influenza is very important, especially for pregnant women and researchers from Saint Louis University are recruiting them to test their immune response as well as the ability of the vaccine to protect newborn infants.
This clinical trial has been launched by the National Institutes of Health as a consequence of the 2009 H1N1 flu pandemic.
Saint Louis University is one of the Vaccine and Treatment Evaluation Units (VTEUs) funded by the National Institute of Allergy and Infectious Diseases (NIAID), and it is one of the few sites in the United States that will recruit pregnant women for the study.
This study should focus on 180 pregnant women and 60 non-pregnant women from the entire US territory, and see if both groups have similar antibody responses to the vaccine; the SLU will assess almost 64 volunteers.
Sharon Frey, MD, clinical director of Saint Louis University's Center for Vaccine Development who is leading the research at SLU, says that “the information from this study will help guide scientists as they work to make vaccines that are more effective in protecting pregnant women and their babies.”
This study will help measure the body's immune response to this year's influenza vaccine and see if it also protects newborn infants.
Frey added that “it is highly recommended that women who are pregnant get vaccinated against influenza because pregnant women can develop very severe illness.
“Pregnant women who have flu are at high risk of heart and lung complications and have a greater chance of premature labor and delivery.”
There are also three major medical organizations – the Advisory Committee on Immunization Practices (ACIP), American College of Obstetricians and Gynecologists (ACOG) and American Academy of Family Physicians, who recommend flu vaccination for women who want to get pregnant or who are likely to have a baby during influenza season.
Besides the mothers' immune responses, the researchers will also analyze how much antibody mothers pass along to their child and to do so, after the delivery of the babies, cord blood will be gathered in order to measure maternal antibodies transferred through the placenta.
Normally “newborns are not protected from flu; they rely on the mother's antibodies for protection.
“Our research will tell us whether vaccinating moms also protects young infants.
“This is important because flu vaccines currently are not approved for babies who are younger than 6 months old,” said Frey.
For more information on this study, please visit the ClinicalTrials.gov website.