Scientific Publications by FDA Staff

Transfusion 2018 May;58(5):1108-16

Characterization of source plasma from self-identified vaccinated or convalescent donors during the 2009 H1N1 pandemic.

Khalenkov A, He Y, Reed JL, Kreil TR, McVey J, Norton M, Scott J, Scott DE

BACKGROUND: Influenza immune globulin, manufactured from plasma of convalescent or vaccinated donors has been proposed as a potential therapy for severe influenza. In 2009, a program was initiated to collect plasma from donors who self-identified as having had H1N1 influenza or having received the H1N1 pandemic vaccine. The goal of this study was to determine the efficiency of donor screening by self-identification without antibody testing, and to evaluate demographic predictors of high-titer donations. STUDY DESIGN AND METHODS: Plasma samples from self-identified or control donors were randomly selected to evaluate hemagglutination inhibition (HAI) antibody responses. HAI titers were correlated with donor age, gender, location, and influenza exposure history. RESULTS: Both self-identified vaccinated and convalescent donor groups had higher geometric mean titers (GMTs) against A/California/07/2009 (H1N1) virus compared to the control donors (39.9, 24, and 8.5, respectively). The proportion of samples with titers >/=64 in vaccinated, convalescent, and control donors were 54%, 37%, and 10%, respectively. Donations with titers