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

• Published in: Vaccine Vol. 32; no. 28; pp. 3548 - 3554
• Main Authors: Pondo, Tracy, Rose, Charles E, Martin, Stacey W, Keitel, Wendy A, Keyserling, Harry L, Babcock, Janiine, Parker, Scott, Jacobson, Robert M, Poland, Gregory A, McNeil, Michael M
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier 12.06.2014; Elsevier Limited
• Subjects: Adult; Age; Allergy and Immunology; Anthrax - prevention & control; Anthrax Vaccines - adverse effects; Antibodies, Bacterial - blood; Antigens; Applied microbiology; Bacteriology; Biological and medical sciences; Body Mass Index; Clinical trials; Continental Population Groups; Double-Blind Method; Drug dosages; Female; Females; Fundamental and applied biological sciences. Psychology; Humans; Immunoglobulin G - blood; Injections; Injections, Intramuscular; Injections, Subcutaneous; Licenses; Logistic Models; Male; Menstruation; Microbiology; Middle Aged; Miscellaneous; Multivariate Analysis; Pain; Progesterone - blood; Sex Factors; Testing laboratories; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Women; United States > US; Body mass index; Anthrax vaccine adsorbed; Anthrax vaccines/adverse events; Immunological response; Sex factors; Race; Bacillus anthracis; Toxicity; Vaccination; Sex; IgG; Bacillaceae; Progestagen; Bacillales; Bacteria; Clinical trial; Serum; Human; Vaccine; Ovarian hormone; Infection; Anthrax; Bacteriosis; Progesterone; Sex steroid hormone
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2014.04.025

Highlights • Women have a higher risk for anthrax vaccine adsorbed (AVA)-associated injection site AEs. • We analyzed data from the CDC AVA human clinical trial for 8 injection site AEs. • Female and non-black participants had a higher proportion of AVA-associated AEs. • Female and non-black participants also had higher anti-PA IgG concentrations. • Antibody responses to other vaccines may also vary by gender and race.