PMID- 24768633 OWN - NLM STAT- MEDLINE DCOM- 20141125 LR - 20211203 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 32 IP - 28 DP - 2014 Jun 12 TI - Evaluation of sex, race, body mass index and pre-vaccination serum progesterone levels and post-vaccination serum anti-anthrax protective immunoglobulin G on injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC AVA human clinical trial. PG - 3548-54 LID - S0264-410X(14)00551-9 [pii] LID - 10.1016/j.vaccine.2014.04.025 [doi] AB - BACKGROUND: Anthrax vaccine adsorbed (AVA) administered intramuscularly (IM) results in fewer adverse events (AEs) than subcutaneous (SQ) administration. Women experience more AEs than men. Antibody response, female hormones, race, and body mass index (BMI) may contribute to increased frequency of reported injection site AEs. METHODS: We analyzed data from the CDC AVA human clinical trial. This double blind, randomized, placebo controlled trial enrolled 1563 participants and followed them through 8 injections (AVA or placebo) over a period of 42 months. For the trial's vaccinated cohort (n=1267), we used multivariable logistic regression to model the effects of study group (SQ or IM), sex, race, study site, BMI, age, and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade. Also, in a women-only subset (n=227), we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs. RESULTS: Participants who received SQ injections had significantly higher proportions of itching, redness, swelling, tenderness and warmth compared to the IM study group after adjusting for other risk factors. The proportions of redness, swelling, tenderness and warmth were all significantly lower in blacks vs. non-black participants. We found arm motion limitation, itching, pain, swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations. In the SQ study group, redness and swelling were more common for obese participants compared to participants who were not overweight. Females had significantly higher proportions of all AEs compared to males. Menstrual phase was not associated with any AEs. CONCLUSIONS: Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations. Antibody responses to other vaccines may also vary by sex and race. Further studies may provide better understanding for higher proportions of AEs in women and non-black participants. CI - Published by Elsevier Ltd. FAU - Pondo, Tracy AU - Pondo T AD - Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: dio2@cdc.gov. FAU - Rose, Charles E Jr AU - Rose CE Jr AD - Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. FAU - Martin, Stacey W AU - Martin SW AD - Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. FAU - Keitel, Wendy A AU - Keitel WA AD - Baylor College of Medicine, Houston, TX, United States. FAU - Keyserling, Harry L AU - Keyserling HL AD - Emory University School of Medicine, Atlanta, GA, United States. FAU - Babcock, Janiine AU - Babcock J AD - Walter Reed Army Institute of Research, Washington, DC, United States. FAU - Parker, Scott AU - Parker S AD - University of Alabama at Birmingham, Birmingham, AL, United States. FAU - Jacobson, Robert M AU - Jacobson RM AD - Mayo Clinic, Rochester, MN, United States. FAU - Poland, Gregory A AU - Poland GA AD - Mayo Clinic, Rochester, MN, United States. FAU - McNeil, Michael M AU - McNeil MM AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. LA - eng GR - CC999999/Intramural CDC HHS/United States PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, U.S. Gov't, P.H.S. DEP - 20140424 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Anthrax Vaccines) RN - 0 (Antibodies, Bacterial) RN - 0 (Immunoglobulin G) RN - 4G7DS2Q64Y (Progesterone) SB - IM MH - Adult MH - Anthrax/prevention & control MH - Anthrax Vaccines/*adverse effects MH - Antibodies, Bacterial/*blood MH - *Body Mass Index MH - Double-Blind Method MH - Female MH - Humans MH - Immunoglobulin G/blood MH - Injections, Intramuscular MH - Injections, Subcutaneous MH - Logistic Models MH - Male MH - Middle Aged MH - Multivariate Analysis MH - Progesterone/*blood MH - *Racial Groups MH - *Sex Factors PMC - PMC5761064 MID - NIHMS930251 OTO - NOTNLM OT - Anthrax vaccine adsorbed OT - Anthrax vaccines/adverse events OT - Body mass index OT - Immunological response OT - Race OT - Sex factors COIS- Conflicts of interest statement No conflicts of interest were reported for any author. EDAT- 2014/04/29 06:00 MHDA- 2014/12/15 06:00 PMCR- 2018/01/10 CRDT- 2014/04/29 06:00 PHST- 2014/02/14 00:00 [received] PHST- 2014/04/08 00:00 [revised] PHST- 2014/04/10 00:00 [accepted] PHST- 2014/04/29 06:00 [entrez] PHST- 2014/04/29 06:00 [pubmed] PHST- 2014/12/15 06:00 [medline] PHST- 2018/01/10 00:00 [pmc-release] AID - S0264-410X(14)00551-9 [pii] AID - 10.1016/j.vaccine.2014.04.025 [doi] PST - ppublish SO - Vaccine. 2014 Jun 12;32(28):3548-54. doi: 10.1016/j.vaccine.2014.04.025. Epub 2014 Apr 24.