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Changing Dosing, Administration of Anthrax Vaccine Reduces Side Effects CHICAGO -- September 30, 2008 -- Reducing the number of doses of an anthrax vaccine adsorbed (AVA) and changing its administration to intramuscular injection resulted in comparable measures of effectiveness but with fewer adverse events, according to a study in the October 1 issue of the Journal of the American Medical Association. "Simpler and better-tolerated regimens for vaccination with anthrax vaccine adsorbed are needed," the authors wrote. The Centers for Disease Control and Prevention, Atlanta, Georgia, in collaboration with several US clinical study sites and the Anthrax Vaccine Research Program Working Group, conducted a randomised clinical trial, which included 1,005 volunteers, to assess safety and serological outcomes of alternative schedules and routes of administration of AVA. Participants received AVA by the subcutaneous (SQ) or intramuscular (IM) route at 0, 2, and 4 weeks, and 6 months (4-SQ or 4-IM; n = 165-170 per group) or at a reduced 3-dose schedule (3-IM; n = 501). A control group (n = 169) received saline injections at the same time intervals. The researchers found that at month 7, after completion of the priming series, all groups had serum antibody responses that were noninferior to the licensed regimen. Most injection site adverse events (AEs), such as warmth, tenderness, itching, abnormal redness of the skin, and swelling, occurred at lower proportions in the 4-IM group compared with the 4-SQ group. The odds ratio for ordinal pain reported immediately after injection was reduced by 50% for the 4-IM versus 4-SQ groups. "Our data demonstrate that a 3-IM regimen elicits serum antibody responses at month 7 that are noninferior when compared with regimens containing 4 doses of AVA," the authors wrote. "Intramuscular administration was associated with a significant reduction in injection site AEs. Changing the injection route from SQ to IM may increase vaccine acceptability. Reducing the number of doses in the AVA regimen would have the added benefit of increasing the number of doses available for prophylactic use." SOURCE: Journal of the American Medical Association. E-mail this page to a friend or colleague! To print, use this version