Assessing the Safety of Anthrax Immunization in US Army Aircrew Members via Physical Examination

Downing, Jill; Greig, Thomas W.; Quattlebaum, Martin; Valentín, Manuel Gómez; Heeren, Timothy; Grabenstein, John D.

doi:10.1097/jom.0b013e318157d305

Cited by 9 publications

(2 citation statements)

References 26 publications

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“…The original approved AVA regimen consisted of 0.5 mL SQ injections at 0, 2 and 4 weeks and 6, 12, and 18 months with annual boosters thereafter [1]. Since the introduction of the Department of Defense’s (DoD) mandatory anthrax vaccination program in 1998 [2], service personnel and others have raised concerns that subsequently have been addressed in various published studies, including those related to high rates of injection site adverse events, (AEs) particularly in women [3–8]; potential reproductive toxicity [9–11]; physical disability [12–15]; and nonspecific longer term symptoms such as Gulf War and chronic fatigue syndromes [16–19]. In 1999, the US Congress directed the Centers for Disease Control and Prevention (CDC) to evaluate the safety and efficacy of AVA and in particular an apparent sex difference in the occurrence of AEs.…”

Section: Introductionmentioning

confidence: 99%

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

Pondo¹,

Rose²,

Martin³

et al. 2014

Vaccine

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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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Section: Introductionmentioning

confidence: 99%

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

Pondo¹,

Rose²,

Martin³

et al. 2014

Vaccine

View full text Add to dashboard Cite

show abstract

“…Thus, we could envisage a scenario in which women from high-risk groups (i.e., military, health care professionals) who had received the anthrax vaccine could transfer to their babies antibodies that can prevent them from mounting a protective immune response following immunization. In 1998, the Department of Defense began the Anthrax Vaccine Immunization Program for designated US Armed Forces Personnel, and as of 2007, 5.5 million doses of BioThrax were administered to more than 1.5 million civilians and military personnel [51]. A single study identified at least 51,000 infants born to military women vaccinated against anthrax (some of them during pregnancy) between 1998 and 2004 [8].…”

Section: Discussionmentioning

confidence: 99%

Mucosal priming of newborn mice with S. Typhi Ty21a expressing anthrax protective antigen (PA) followed by parenteral PA-boost induces B and T cell-mediated immunity that protects against infection bypassing maternal antibodies

Ramírez

Ditamo

Galen

et al. 2010

Vaccine

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The currently licensed anthrax vaccine has several limitations and its efficacy has been proven only in adults. Effective immunization of newborns and infants requires adequate stimulation of their immune system, which is competent but not fully activated. We explored the use of the licensed live attenuated S. Typhi vaccine strain Ty21a expressing Bacillus anthracis protective antigen [Ty21a(PA)] followed PA-alum as a strategy for immunizing the pediatric population. Newborn mice primed with a single dose of Ty21a(PA) exhibited high frequencies of mucosal IgA-secreting B cells and IFN-γ-secreting T cells during the neonatal period, none of which was detected in newborns immunized with a single dose of PA-alum. Priming with Ty21a(PA) followed by PA-boost resulted in high levels of PA-specific IgG, toxin-neutralizing and opsonophagocytic antibodies and increased frequency of bone marrow IgG plasma cells and memory B cells compared with repeated immunization with PA-alum alone. Robust B and T cell responses developed even in the presence of maternal antibodies. The prime-boost protected against systemic and respiratory infection. Mucosal priming with a safe and effective S. Typhibased anthrax vaccine followed by PA-boost could serve as a practical and effective prophylactic approach to prevent anthrax early in life.

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Current awareness: Pharmacoepidemiology and drug safety

2008

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 20 sections: 1 Reviews; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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Assessing the Safety of Anthrax Immunization in US Army Aircrew Members via Physical Examination

Abstract: No attributable risk of anthrax immunization was observed in this group of Army aircrew members.

Cited by 9 publications

References 26 publications

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

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

Mucosal priming of newborn mice with S. Typhi Ty21a expressing anthrax protective antigen (PA) followed by parenteral PA-boost induces B and T cell-mediated immunity that protects against infection bypassing maternal antibodies

Current awareness: Pharmacoepidemiology and drug safety

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