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.
Author(s): Pondo T(1), Rose CE Jr(2), Martin SW(2), Keitel WA(3), Keyserling HL(4), Babcock
J(5), Parker S(6), Jacobson RM(7), Poland GA(7), McNeil MM(8).
Affiliation(s): Author information:
(1)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. (2)Division of Bacterial
Diseases, National Center for Immunization and Respiratory Diseases, Centers for
Disease Control and Prevention, Atlanta, GA, United States. (3)Baylor College of
Medicine, Houston, TX, United States. (4)Emory University School of Medicine,
Atlanta, GA, United States. (5)Walter Reed Army Institute of Research,
Washington, DC, United States. (6)University of Alabama at Birmingham,
Birmingham, AL, United States. (7)Mayo Clinic, Rochester, MN, United States.
(8)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.
Publication date & source: 2014, Vaccine. , 32(28):3548-54
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.
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