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