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Abstract Details

Activity Number: 572
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306441
Title: A Bivariate Normal Random-Effects Model with Left-Censoring to Estimate Duration of Antibody and TNA Responses to Anthrax Vaccine in Non-Human Primates
Author(s): Charles Rose*+ and Brian D Plikaytis and Conrad P Quinn
Companies: CDC and CDC and CDC
Address: 1600 Clifton Rd. NE, Atlanta, GA, 30333, United States
Keywords: Bivariate Normal Random-Effects Model ; Left-Censoring ; Anthrax Vaccine Adsorbed (AVA) ; Antibody and TNA Decay ; Correlate of Protection

We developed a Bivariate Normal (BVN) random-effects model with left censoring to simultaneously estimate anthrax lethal toxin neutralization activity (TNA) titer and anti-PA antibody (aPA) concentration immune responses to the US licensed Anthrax Vaccine Adsorbed (AVA) in Rhesus macaque non-human primates (NHP). Data were from the CDC NHP correlates of protection study that administered AVA as a 3-dose IM priming series (0, 1, 6m) with no boosters. Magnitudes of NHP antibody responses were modulated using divided doses of AVA (dilution in sterile saline; undiluted AVA, 1/5, 1/10, 1/20, 1/40). To demonstrate our model, we use the NHP group's 1/5 and 1/10 data, which consist of 257 and 367 observations for 17 and 29 subjects, respectively. Measurements at or below lower limit of quantification of 2.3 µg/mL aPA and TNA titer 36 were treated as left-censored. The NHP group's 1/5 and 1/10 had 15 and 123, and 11 and 99 censored observations for TNA and aPA, respectively. We estimate aPA concentration and TNA titer persistence for the 36m span between month 6 and 42. We compare estimates and demonstrate model fit improvement using the BVN model versus modeling aPA and TNA independently.

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