Health-related quality of life in the CDC Anthrax Vaccine Adsorbed Human Clinical Trial

Brock Stewart, Charles E. Rose, Jerome I. Tokars, Stacey W. Martin, Wendy A. Keitel, Harry L. Keyserling, Janiine Babcock, Scott D. Parker, Robert M. Jacobson, Gregory A. Poland, Michael M. McNeil

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)5875-5879
Number of pages5
Issue number40
StatePublished - Aug 31 2012


  • AVA Clinical Trial
  • Health survey
  • Quality of life

ASJC Scopus subject areas

  • Molecular Medicine
  • General Immunology and Microbiology
  • General Veterinary
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases


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