Geeta Swamy, MD, and Sarah Dotters-Katz , MD, have been awarded a $1 million, 3-year contract with the CDC’s Clinical Immunization Safety Assessment (CISA) to lead a multi-center randomized trial of Flublok® influenza vaccine in pregnant women. Dr. Swamy is the PI, and Dr. Dotters-Katz is co-investigator.
Flublok® is a recombinant vaccine that does not involve eggs during production. Although Flublok® is approved for use in adults, there is very little systematically collected data on the effectiveness or safety of the vaccine in pregnant women.
Information from this study will be used to directly inform public health and obstetric leaders on the recommendation for use of Flublok® in pregnant women, particularly during a pandemic or supply shortage when pregnant women are prioritized for vaccination.
Following study development, enrollment will begin in the fall of 2019 and offered to pregnant women across Duke Ob/Gyn.