Generalized ROC methods for immunogenicity data analysis of vaccine phase I studies in a seropositive population

• Main Authors: Li Yu (Author), Mark T. Esser (Author), Judith Falloon (Author), Tonya Villafana (Author), Harry Yang (Author)
• Format: Book
• Published: Taylor & Francis Group, 2018-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Immunogenicity data from phase 1 vaccine studies can be difficult to interpret, especially in seropositive populations and when multiple assays are used. We developed 3 statistical methods (Youden index [YI] threshold, receiver-operating characteristic relative to baseline [ROC-B], and ROC of postdo...