{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T14:43:26Z","timestamp":1788878606815,"version":"build-2803163510"},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2005,2,16]],"date-time":"2005-02-16T00:00:00Z","timestamp":1108512000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2005,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The CDC's Anthrax Vaccine and Antibiotic Availability Program was implemented under an Investigational New Drug (IND) application to provide additional post\u2010exposure prophylaxis for individuals potentially exposed to <jats:italic>Bacillus anthracis<\/jats:italic> in the fall of 2001. Participants were provided with two options: (1) 40 additional days of antimicrobial prophylaxis (i.e., ciprofloxacin, doxycycline, or amoxicillin); or (2) 40 additional days of antimicrobial prophylaxis plus three doses of anthrax vaccine adsorbed (AVA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants were monitored for adverse events (AEs). Participants were asked to complete 2\u2010week AE diaries for 6 weeks post\u2010enrollment, and approximately 2 months after enrollment, active surveillance was conducted through telephone interviews with 1113 (64%) participants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 1727 of approximately 10\u2009000 previously prophylaxed persons enrolled to receive 40 additional days of antibiotics. Of these, 199 opted at enrollment to receive three doses of AVA in addition to the additional 40 days of antibiotic. Overall, 28% of participants reported at least one AE on their diaries. Results varied by surveillance mechanism, the diary data indicated differences in the proportion reporting AEs between participants receiving antibiotic only and participants receiving antibiotic and AVA. However, during the active 2\u2010month telephone follow\u2010up, the rates of AEs reported for both the antibiotic only and antibiotic plus AVA treatment regimens were similar. Additionally, ciprofloxacin and doxycycline had similar AE profiles, with only rigors reported significantly more often among ciprofloxacin recipients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Overall, the rates of AEs experienced by all participants were acceptable given the seriousness of potential <jats:italic>B. anthracis<\/jats:italic> exposure. Copyright \u00a9 2005 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.1085","type":"journal-article","created":{"date-parts":[[2005,2,16]],"date-time":"2005-02-16T18:20:36Z","timestamp":1108578036000},"page":"393-401","source":"Crossref","is-referenced-by-count":18,"title":["An overview of adverse events reported by participants in CDC's anthrax vaccine and antimicrobial availability program"],"prefix":"10.1002","volume":"14","author":[{"given":"Stacey W.","family":"Martin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce C.","family":"Tierney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Aranas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy E.","family":"Rosenstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura H.","family":"Franzke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis","family":"Apicella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Marano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael M.","family":"McNeil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2005,2,16]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid0810.020353"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid0810.020349"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.18.1735"},{"key":"e_1_2_1_5_2","article-title":"Use of anthrax vaccine in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"49","author":"CDC","year":"2000","journal-title":"MMWR"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1086\/377738"},{"key":"e_1_2_1_7_2","unstructured":"CDC Responds:Update on Options for Preventive Treatment for Persons at Risk for Inhalational Anthrax. December 21 2001. Transcript located at:http:\/\/www.bt.cdc.gov\/agent\/anthrax\/PreventiveTreatment12212001.asp"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0022172400044272"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/167.5.1239"},{"key":"e_1_2_1_10_2","unstructured":"KournikakisB ArmourSJ BouletCA SpenceM BarsonsB.Risk assessment of anthrax threat letters. Suffield: DRES Technical Report TR 2001\u2010048; September2001."},{"key":"e_1_2_1_11_2","first-page":"1051","article-title":"Update: Adverse events associated with anthrax prophylaxis among postal employees\u2014New Jersey, New York, and the District of Columbia Metropolitan Area","volume":"50","author":"CDC","year":"2001","journal-title":"MMWR"},{"key":"e_1_2_1_12_2","volume-title":"The Anthrax Vaccine: Is it safe?","author":"Institute of Medicine","year":"2002"},{"key":"e_1_2_1_13_2","unstructured":"In: Physicians desk reference. Available (to subscribers only) athttp:\/\/www.pdrel.thomsonhc.com. [Accessed 5 December2003]."},{"key":"e_1_2_1_14_2","volume-title":"Federal Register","year":"1997"},{"key":"e_1_2_1_15_2","unstructured":"MedDRA\u00ae is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)."},{"key":"e_1_2_1_16_2","unstructured":"Anthrax Vaccine Adsorbed (BIOTHRAX\u2122) Package Insert.2002.Manufactured by Bioport Corporation Lansing Michigan US Lic No. 1260."},{"key":"e_1_2_1_17_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.712"},{"key":"e_1_2_1_18_2","first-page":"73","volume-title":"51st Annual Epidemic Intelligence Service Conference Program and Abstracts Book","author":"Jefferds MD","year":"2002"},{"key":"e_1_2_1_19_2","doi-asserted-by":"publisher","DOI":"10.1080\/08964289.1991.9937553"},{"key":"e_1_2_1_20_2","first-page":"67","article-title":"Coping with stress: neuroendocrine reactions and implications for health","volume":"1","author":"Lundberg U","year":"1999","journal-title":"Noise Health"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.1085","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.1085","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,17]],"date-time":"2023-11-17T01:48:58Z","timestamp":1700185738000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.1085"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2005,2,16]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2005,6]]}},"alternative-id":["10.1002\/pds.1085"],"URL":"https:\/\/doi.org\/10.1002\/pds.1085","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2005,2,16]]}}}