Statistical Modeling of the Duration of Protection of Postvaccination Antibody

• Activity Number: 513
• Type: Contributed
• Date/Time: Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jason Martin*+ and Stephanie Klopfer
• Companies: Merck & Co., Inc. and Merck & Co., Inc.
• Keywords: Vaccine ; Persistence ; Exponential ; Decay ; Extrapolation ; Modeling

Abstract

Clinical studies supporting the licensure of a new vaccine typically only measure the vaccine's effect for a few months to a few years after vaccination. However, of interest to public health experts and vaccine policy makers is the long-term duration of protection from disease after vaccination. Various statistical models were evaluated to extrapolate the long-term persistence and duration of detectable antibody after receipt of hepatitis vaccine based on shorter-term data. Historically, exponential decay models have been used to assess long-term hepatitis antibody persistence using observed persistence data up to 3 years postvaccination. The current investigation updates these historical models with observed data up to 10 years postvaccination, as well as evaluates additional extrapolation models based on mixed effects and piece-wise mixed effects models and a power law model.