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Clinical Trial
. 2012 Aug 31;30(40):5875-9.
doi: 10.1016/j.vaccine.2012.06.076. Epub 2012 Jul 17.

Health-related Quality of Life in the CDC Anthrax Vaccine Adsorbed Human Clinical Trial

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Free PMC article
Clinical Trial

Health-related Quality of Life in the CDC Anthrax Vaccine Adsorbed Human Clinical Trial

Brock Stewart et al. Vaccine. .
Free PMC article

Abstract

Background: After the Department of Defense implemented a mandatory anthrax vaccination program in 1998 concerns were raised about potential long-term safety effects of the current anthrax vaccine. The CDC multicenter, randomized, double-blind, placebo-controlled Anthrax Vaccine Adsorbed (AVA) Human Clinical Trial to evaluate route change and dose reduction collected data on participants' quality of life. Our objective is to assess the association between receipt of AVA and changes in health-related quality of life, as measured by the SF-36 health survey (Medical Outcomes Trust, Boston, MA), over 42 months after vaccination.

Methods: 1562 trial participants completed SF-36v2 health surveys at 0, 12, 18, 30 and 42 months. Physical and mental summary scores were obtained from the survey results. We used Generalized Estimating Equations (GEE) analyses to assess the association between physical and mental score difference from baseline and seven study groups receiving either AVA at each dose, saline placebo at each dose, or a reduced AVA schedule substituting saline placebo for some doses.

Results: Overall, mean physical and mental scores tended to decrease after baseline. However, we found no evidence that the score difference from baseline changed significantly differently between the seven study groups.

Conclusions: These results do not favor an association between receipt of AVA and an altered health-related quality of life over a 42-month period.

Conflict of interest statement

Conflict of interest statement: None of the authors have conflicts of interest to declare.

Figures

Fig. 1.
Fig. 1.
Results from multivariable GEE models by time point: means and 95% confidence intervals of subsequent scores minus baseline scores (plots), and p-values for changing differently from baseline (table), CDC Anthrax Vaccine Adsorbed Human Clinical Trial, 2002-2005.

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