PMID- 18781705 OWN - NLM STAT- MEDLINE DCOM- 20081211 LR - 20131121 IS - 1099-1557 (Electronic) IS - 1053-8569 (Linking) VI - 17 IP - 11 DP - 2008 Nov TI - Evaluation of body mass index, pre-vaccination serum progesterone levels and anti-anthrax protective antigen immunoglobulin G on injection site adverse events following anthrax vaccination in women. PG - 1060-7 LID - 10.1002/pds.1657 [doi] AB - BACKGROUND: In 2002, CDC initiated the Anthrax Vaccination Program (AVP) to provide voluntary pre-exposure anthrax vaccination for individuals at high risk for exposure to Bacillus anthracis spores. The AVP offered an opportunity to investigate hypothesized reasons for a reported gender difference in injection site adverse events (AEs) following anthrax vaccine adsorbed (AVA). OBJECTIVES: To evaluate in women the impact of body mass index (BMI), pre-vaccination serum progesterone levels, and pre-vaccination anti-anthrax protective antigen immunoglobulin G concentrations (anti-PA IgG) on the occurrence of AEs following subcutaneous AVA vaccination. METHODS: Participants' BMI was determined at enrollment. Also, pre-vaccination blood samples were assayed for serum progesterone and anti-PA IgG. Post-vaccination solicited AEs were recorded by participants using a 4-day diary card. RESULTS: Obese group had an elevated risk for arm soreness. Decreased pre-vaccination serum progesterone level was associated with arm swelling. Increased pre-vaccination anti-PA IgG was associated with itching on the arm; and within the obese group, was associated with arm swelling, lump or knot, redness, soreness, and warmth. CONCLUSIONS: In AVA vaccinated women, obesity was associated with arm soreness and decreased pre-vaccination serum progesterone levels were associated with increased rate of arm swelling. Increased pre-vaccination anti-PA IgG may be associated with an increased frequency of itching on the arm, and in obese women, may increase the occurrence of arm swelling, lump or knot, redness, and warmth. Administering AVA according to a woman's menstrual phase may reduce the occurrence of certain injection site reactions. CI - Copyright (c) 2008 John Wiley & Sons, Ltd. FAU - Zhang, Yujia AU - Zhang Y AD - Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA, USA. FAU - Martin, Stacey W AU - Martin SW FAU - Rose, Charles E Jr AU - Rose CE Jr FAU - Biagini, Raymond E AU - Biagini RE FAU - Franzke, Laura H AU - Franzke LH FAU - Smith, Jerry P AU - Smith JP FAU - Sammons, Deborah L AU - Sammons DL FAU - Robertson, Shirley A AU - Robertson SA FAU - McNeil, Michael M AU - McNeil MM LA - eng GR - Y1-ES-0001/ES/NIEHS NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PL - England TA - Pharmacoepidemiol Drug Saf JT - Pharmacoepidemiology and drug safety JID - 9208369 RN - 0 (Anthrax Vaccines) RN - 0 (Antibodies, Bacterial) RN - 0 (Immunoglobulin G) RN - 4G7DS2Q64Y (Progesterone) SB - IM MH - Adolescent MH - Adult MH - Anthrax/*immunology MH - Anthrax Vaccines/administration & dosage/*adverse effects MH - Antibodies, Bacterial/*blood MH - Arm MH - *Body Mass Index MH - Edema/*etiology/immunology/metabolism MH - Female MH - Humans MH - Immunoglobulin G/*blood MH - Injections MH - Male MH - Middle Aged MH - Obesity/blood/*complications/immunology MH - Odds Ratio MH - Progesterone/*blood MH - Pruritus/*etiology/immunology/metabolism MH - Risk Assessment MH - Risk Factors MH - Sex Factors MH - Young Adult EDAT- 2008/09/11 09:00 MHDA- 2008/12/17 09:00 CRDT- 2008/09/11 09:00 PHST- 2008/09/11 09:00 [pubmed] PHST- 2008/12/17 09:00 [medline] PHST- 2008/09/11 09:00 [entrez] AID - 10.1002/pds.1657 [doi] PST - ppublish SO - Pharmacoepidemiol Drug Saf. 2008 Nov;17(11):1060-7. doi: 10.1002/pds.1657.