Recent developments in the understanding and use of anthrax vaccine adsorbed: achieving more with less

References

• Inglesby TV, O’Toole T, Henderson DA, et al. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA. 2002;287(17):2236–2252.
   PubMed Web of Science ®Google Scholar
• Johnson AD, Spero L. Comparison of growth and toxin production in two vaccine strains of Bacillus anthracis. Appl Environ Microbiol. 1981;41(6):1479–1481.
   PubMed Web of Science ®Google Scholar
• Mazzuchi JF, Claypool RG, Hyams KC, et al. Protecting the health of U.S. military forces: a national obligation. Aviat Space Environ Med. 2000;71(3):260–265.
   PubMedGoogle Scholar
• Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-up Agency. The anthrax vaccine: is it safe? Does it work? (Joellenbeck L, Zwanziger L, Durch J, Strom BE, editors). Washington, DC: Institute of Medicine, National Academy Press; 2002.
   Google Scholar
• Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-up Agency. An Assessment of the CDC anthrax vaccine safety and efficacy research program. (Joellenbeck L, Zwanziger L, Durch J, Kazmerzak K, Bailey P, Miller RE, editors). Washington, DC: Institute of Medicine, National Academy Press; 2002.
   Google Scholar
• Pittman PR, Kim-Ahn G, Pifat DY, et al. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine. 2002;20(9–10):1412–1420.
   PubMed Web of Science ®Google Scholar
• Marano N, Plikaytis BD, Martin SW, et al. Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months: a randomized trial. JAMA. 2008;300(13):1532–1543.
   PubMed Web of Science ®Google Scholar
• Wright JG, Plikaytis BD, Rose CE, et al. Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: a randomized trial. Vaccine. 2014;32(8):1019–1028.
   PubMed Web of Science ®Google Scholar
• Niu MT, Ball R. Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007. Vaccine. 2009;27(2):6654–6655.
   PubMed Web of Science ®Google Scholar
• Niu MT, Ball R, Woo EJ, et al. Adverse events after anthrax vaccination reported to the vaccine adverse event reporting system (VAERS), 1990-2007. Vaccine. 2009;27(2):290–297.
   PubMed Web of Science ®Google Scholar
• Wright JG, Quinn CP, Shadomy S, et al. Use of anthrax vaccine in the United States: recommendations of the advisory committee on immunization practices (ACIP), 2009. MMWR Recomm Rep. Recommendations and Reports/Centers for Disease Control. 2010;59(Rr–6):1–30.
   PubMedGoogle Scholar
• Jefferson T, Rudin M, Di Pietrantonj C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004;4(2):84–90.
   PubMed Web of Science ®Google Scholar
• Downing J, Greig TW, Quattlebaum MD, et al. Assessing the safety of anthrax immunization in US army aircrew members via physical examination. J Occupational Environ Med/American Coll Occup Environ Med. 2007;49(10):1079–1085.
   PubMed Web of Science ®Google Scholar
• Rehme PA, Williams R, Grabenstein J. Ambulatory medical visits among anthrax-vaccinated and unvaccinated personnel after return from southwest Asia. Mil Med. 2002;167(3):205–210.
   PubMed Web of Science ®Google Scholar
• Sato PA, Reed RJ, Smith TC, et al. Monitoring anthrax vaccine safety in US military service members on active duty: surveillance of 1998 hospitalizations in temporal association with anthrax immunization. Vaccine. 2002;20(17–18):2369–2374.
   PubMed Web of Science ®Google Scholar
• Smith B, Leard CA, Smith TC, et al. Anthrax vaccination in the millennium cohort: validation and measures of health. Am J Prev Med. 2007;32(4):347–353.
   PubMed Web of Science ®Google Scholar
• Sulsky SI, Grabenstein JD, Delbos RG. Disability among U.S. army personnel vaccinated against anthrax. J Occupational Environ Med/American Coll Occup Environ Med. 2004;46(10):1065–1075.
   PubMed Web of Science ®Google Scholar
• Catherino WH, Levi A, Kao TC, et al. Anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member. Fertil Steril. 2005;83(2):480–483.
   PubMed Web of Science ®Google Scholar
• Pittman PR, Coonan KM, Gibbs PH, et al. Long-term health effects of repeated exposure to multiple vaccines. Vaccine. 2004;23(4):525–536.
   PubMed Web of Science ®Google Scholar
• Payne DC, Franzke LH, Stehr-Green PA, et al. Development of the vaccine analytic unit’s research agenda for investigating potential adverse events associated with anthrax vaccine adsorbed. Pharmacoepidemiol Drug Saf. 2007;16(1):46–54.
   PubMed Web of Science ®Google Scholar
• Payne DC, Rose CE Jr., Kerrison J, et al. Anthrax vaccination and risk of optic neuritis in the United States military, 1998-2003. Arch Neurol. 2006;63(6):871–875.
   PubMedGoogle Scholar
• Duderstadt SK, Rose CE Jr., Real TM, et al. Vaccination and risk of type 1 diabetes mellitus in active component U.S. military, 2002-2008. Vaccine. 2012;30(4):813–819.
   PubMed Web of Science ®Google Scholar
• Payne DC, Aranas A, McNeil MM, et al. Concurrent vaccinations and U.S. military hospitalizations. Ann Epidemiol. 2007;17(9):697–703.
   PubMed Web of Science ®Google Scholar
• Stewart B, Rose CE, Tokars JI, et al. Health-related quality of life in the CDC anthrax vaccine adsorbed human clinical trial. Vaccine. 2012;30(40):5875–5879.
   PubMed Web of Science ®Google Scholar
• Stewart B, Zhang Y, Rose CE Jr., et al. Health-related quality of life in the anthrax vaccination program for workers in the laboratory response network. Vaccine. 2012;30(10):1841–1846.
   PubMed Web of Science ®Google Scholar
• Unwin C, Blatchley N, Coker W, et al. Health of UK servicemen who served in Persian Gulf War. Lancet. 1999;353(9148):169–178.
   PubMed Web of Science ®Google Scholar
• Asa PB, Wilson RB, Garry RF. Antibodies to squalene in recipients of anthrax vaccine. Exp Mol Pathol. 2002;73(1):19–27.
   PubMed Web of Science ®Google Scholar
• Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf W. In: Fulco CE, Liverman CT, Sox HC, editors. Gulf war and health: volume 1, Chap. 7. Depleted uranium, sarin, pyridostigmine bromide, vaccines. Washington (DC): National Academies Press (US); 2000.
   Google Scholar
• Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000;152(10):992–1002.
   PubMed Web of Science ®Google Scholar
• Matyas GR, Rao M, Pittman PR, et al. Detection of antibodies to squalene: III. Naturally occurring antibodies to squalene in humans and mice. J Immunol Methods. 2004;286(1–2):47–67.
   PubMed Web of Science ®Google Scholar
• Phillips CJ, Matyas GR, Hansen CJ, et al. Antibodies to squalene in US Navy Persian Gulf War veterans with chronic multisymptom illness. Vaccine. 2009;27(29):3921–3926.
   PubMed Web of Science ®Google Scholar
• Sever JL, Brenner AI, Gale AD, et al. Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiol Drug Saf. 2004;13(12):825–840.
   PubMed Web of Science ®Google Scholar
• Cook IF. Sex differences in injection site reactions with human vaccines. Hum Vaccin. 2009;5(7):441–449.
   PubMed Web of Science ®Google Scholar
• Klein SL, Jedlicka A, Pekosz A. The Xs and Y of immune responses to viral vaccines. Lancet Infect Dis. 2010;10(5):338–349.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Martin SW, Rose CE Jr., et al. 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. Pharmacoepidemiol Drug Saf. 2008;17(11):1060–1067.
   PubMed Web of Science ®Google Scholar
• Pondo T, Rose CE Jr., Martin SW, et al. 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. Vaccine. 2014;32(28):3548–3554.
   PubMed Web of Science ®Google Scholar
• King JC Jr., Gao Y, Quinn CP, et al. Evaluation of anthrax vaccine safety in 18 to 20 year olds: a first step towards age de-escalation studies in adolescents. Vaccine. 2015;33(21):2470–2476.
   PubMed Web of Science ®Google Scholar
• Cavalcanti DP, Salomao MA, Lopez-Camelo J, et al. Early exposure to yellow fever vaccine during pregnancy. Trop Med Int Health. 2007;12(7):833–837.
   PubMed Web of Science ®Google Scholar
• Czeizel AE, Rockenbauer M. Tetanus toxoid and congenital abnormalities. Int J Gynaecol Obstet. 1999;64(3):253–258.
   PubMed Web of Science ®Google Scholar
• Grabenstein JD. Pregnancy and lactation in relation to vaccines and antibodies. Pharm Pract Manag Q. 2001;20(3):1–10.
   PubMedGoogle Scholar
• Munoz FM, Englund JA. Vaccines in pregnancy. Infect Dis Clin North Am. 2001;15(1):253–271.
   PubMed Web of Science ®Google Scholar
• Ryan MA, Smith TC, Sevick CJ, et al. Birth defects among infants born to women who received anthrax vaccine in pregnancy. Am J Epidemiol. 2008;168(4):434–442.
   PubMed Web of Science ®Google Scholar
• Meaney-Delman D, Zotti ME, Creanga AA, et al. Special considerations for prophylaxis for and treatment of anthrax in pregnant and postpartum women. Emerg Infect Dis. 2014;20(2).
   PubMedGoogle Scholar
• Wiesen AR, Littell CT. Relationship between prepregnancy anthrax vaccination and pregnancy and birth outcomes among US army women. JAMA. 2002;287(12):1556–1560.
   PubMed Web of Science ®Google Scholar
• Conlin AM, Bukowinski AT, Gumbs GR. Analysis of pregnancy and infant health outcomes among women in the national smallpox vaccine in pregnancy registry who received anthrax vaccine adsorbed. Vaccine. 2015;33(36):4387–4439.
   PubMed Web of Science ®Google Scholar
• Healy CM, Baker CJ. Prospects for prevention of childhood infections by maternal immunization. Curr Opin Infect Dis. 2006;19(3):271–276.
   PubMed Web of Science ®Google Scholar
• CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practice (ACIP). MMWR Recomm Rep. 2011;60(2):1–64.
   Google Scholar
• Haq K, McElhaney JE. Immunosenescence: influenza vaccination and the elderly. Curr Opin Immunol. 2014;29:38–42.
   PubMed Web of Science ®Google Scholar
• Pawelec G, Goldeck D, Derhovanessian E. Inflammation, ageing and chronic disease. Curr Opin Immunol. 2014;29:23–28.
   PubMed Web of Science ®Google Scholar
• Giefing-Kroll C, Berger P, Lepperdinger G, et al. How sex and age affect immune responses, susceptibility to infections, and response to vaccination. Aging Cell. 2015;14(3):309–321.
   PubMed Web of Science ®Google Scholar
• Minang JT, Inglefield JR, Harris AM, et al. Enhanced early innate and T cell-mediated responses in subjects immunized with anthrax vaccine adsorbed plus CPG 7909 (AV7909). Vaccine. 2014;32(50):6847–6854.
   PubMed Web of Science ®Google Scholar
• Rynkiewicz D, Rathkopf M, Sim I, et al. Marked enhancement of the immune response to BioThrax(R) (Anthrax Vaccine Adsorbed) by the TLR9 agonist CPG 7909 in healthy volunteers. Vaccine. 2011;29(37):6313–6320.
   PubMed Web of Science ®Google Scholar
• Garman L, Dumas EK, Kurella S, et al. MHC class II and non-MHC class II genes differentially influence humoral immunity to Bacillus anthracis lethal factor and protective antigen. Toxins. 2012;4(12):1451–1467.
   PubMed Web of Science ®Google Scholar
• Poland GA, Ovsyannikova IG, Jacobson RM, et al. Heterogeneity in vaccine immune response: the role of immunogenetics and the emerging field of vaccinomics. Clin Pharmacol Ther. 2007;82(6):653–664.
   PubMed Web of Science ®Google Scholar
• Pajewski NM, Parker SD, Poland GA, et al. The role of HLA-DR-DQ haplotypes in variable antibody responses to anthrax vaccine adsorbed. Genes Immun. 2011;12(6):457–465.
   PubMed Web of Science ®Google Scholar
• Pajewski NM, Shrestha S, Quinn CP, et al. A genome-wide association study of host genetic determinants of the antibody response to anthrax vaccine adsorbed. Vaccine. 2012;30(32):4778–4784.
   PubMed Web of Science ®Google Scholar
• Falola MI, Wiener HW, Wineinger NE, et al. Genomic copy number variants: evidence for association with antibody response to anthrax vaccine adsorbed. Plos One. 2013;8(5):e64813.
   PubMed Web of Science ®Google Scholar
• Ovsyannikova IG, Pankratz VS, Vierkant RA, et al. Human leukocyte antigens and cellular immune responses to anthrax vaccine adsorbed. Infect Immun. 2013;81(7):2584–2591.
   PubMed Web of Science ®Google Scholar
• Pittman PR, Cavicchia MA, Kingsbury JL, et al. Anthrax vaccine adsorbed: further evidence supporting continuing the vaccination series rather than restarting the series when doses are delayed. Vaccine. 2014;32(39):5131–5139.
   PubMed Web of Science ®Google Scholar
• Pittman PR, Fisher D, Quinn X, et al. Effect of delayed anthrax vaccine dose on Bacillus anthracis protective antigen IgG response and lethal toxin neutralization activity. Vaccine. 2013;31(44):5009–5014.
   PubMed Web of Science ®Google Scholar
• Pittman PR, Mangiafico JA, Rossi CA, et al. Anthrax vaccine: increasing intervals between the first two doses enhances antibody response in humans. Vaccine. 2000;19(2–3):213–216.
   PubMed Web of Science ®Google Scholar
• Quinn CP, Sabourin CL, Niemuth NA, et al. A three-dose intramuscular injection schedule of anthrax vaccine adsorbed generates sustained humoral and cellular immune responses to protective antigen and provides long-term protection against inhalation anthrax in rhesus macaques. Clin Vaccine Immunol. 2012;19(11):1730–1745.
   PubMed Web of Science ®Google Scholar
• Brachman PS, Gold H, Plotkin SA, et al. Field evaluation of a human anthrax vaccine. Am J Public Health Nations Health. 1962;52(4):632–645.
   PubMed Web of Science ®Google Scholar
• Price LB, Hugh-Jones M, Jackson PJ, et al. Genetic diversity in the protective antigen gene of Bacillus anthracis. J Bacteriol. 1999;181(8):2358–2362.
   PubMed Web of Science ®Google Scholar
• Sue D, Marston CK, Hoffmaster AR, et al. Genetic diversity in a Bacillus anthracis historical collection (1954 to 1988). J Clin Microbiol. 2007;45(6):1777–1782.
   PubMed Web of Science ®Google Scholar
• Fellows PF, Linscott MK, Ivins BE, et al. Efficacy of a human anthrax vaccine in guinea pigs, rabbits, and rhesus macaques against challenge by Bacillus anthracis isolates of diverse geographical origin. Vaccine. 2001;19(23–24):3241–3247.
   PubMed Web of Science ®Google Scholar
• Ionin B, Hopkins RJ, Pleune B, et al. Evaluation of immunogenicity and efficacy of anthrax vaccine adsorbed for postexposure prophylaxis. Clin Vaccine Immunol. 2013;20(7):1016–1026.
   PubMed Web of Science ®Google Scholar
• Burns DL. Licensure of vaccines using the animal rule. Curr Opin Virol. 2012;2(3):353–356.
   PubMed Web of Science ®Google Scholar
• Chen L, Schiffer JM, Dalton S, et al. Comprehensive analysis and selection of anthrax vaccine adsorbed immune correlates of protection in rhesus macaques. Clin Vaccine Immunol. 2014;21(11):1512–1520.
   PubMed Web of Science ®Google Scholar
• Fay MP, Follmann DA, Lynn F, et al. Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challenge. Sci Transl Med. 2012;4(151):151ra126.
   PubMed Web of Science ®Google Scholar
• Schiffer JM, Chen L, Dalton S, et al. Bridging non-human primate correlates of protection to reassess the anthrax vaccine adsorbed booster schedule in humans. Vaccine. 2015;33(31):3709–3716.
   PubMed Web of Science ®Google Scholar
• Henderson DW, Peacock S, Belton FC. Observations on the prophylaxis of experimental pulmonary anthrax in the monkey. J Hyg. 1956;54(1):28–36.
   PubMedGoogle Scholar
• Meselson M, Guillemin J, Hugh-Jones M, et al. The Sverdlovsk anthrax outbreak of 1979. Science. 1994;266(5188):1202–1208.
   PubMed Web of Science ®Google Scholar
• Hopkins RJ, Howard C, Hunter-Stitt E, et al. Phase 3 trial evaluating the immunogenicity and safety of a three-dose BioThrax(R) regimen for post-exposure prophylaxis in healthy adults. Vaccine. 2014;32(19):2217–2224.
   PubMed Web of Science ®Google Scholar
• Bernstein DI, Jackson L, Patel SM, et al. Immunogenicity and safety of four different dosing regimens of anthrax vaccine adsorbed for post-exposure prophylaxis for anthrax in adults. Vaccine. 2014;32(47):6284–6293.
   PubMed Web of Science ®Google Scholar
• Bowman CS, Arino J, Moghadas SM. Evaluation of vaccination strategies during pandemic outbreaks. Math Biosci Eng. 2011;8(1):113–122.
   PubMed Web of Science ®Google Scholar
• Hopkins RJ, Daczkowski NF, Kaptur PE, et al. Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of anthrax vaccine adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers. Vaccine. 2013;31(30):3051–3058.
   PubMed Web of Science ®Google Scholar
• Krieg AM, Efler SM, Wittpoth M, et al. Induction of systemic TH1-like innate immunity in normal volunteers following subcutaneous but not intravenous administration of CPG 7909, a synthetic B-class CpG oligodeoxynucleotide TLR9 agonist. J Immunother (Hagerstown, Md.: 1997). 2004;27(6):460–471.
   PubMed Web of Science ®Google Scholar
• Saile E, Quinn CP. Anthrax vaccines. In: Bergman N, editor. Bacillus anthracis and anthrax. Hoboken (NJ): Wiley-Blackwell; 2010. p. 269–293.
   Google Scholar
• Meaney-Delman D, Rasmussen SA, Beigi RH, et al. Prophylaxis and treatment of anthrax in pregnant women. Obstet Gynecol. 2013;122(4):885–900.
   PubMed Web of Science ®Google Scholar
• Bradley JS, Peacock G, Krug SE, et al. Pediatric anthrax clinical management: executive summary. Pediatrics. 2014;133(5):940–942.
   PubMed Web of Science ®Google Scholar
• Reed MD, Wilder JA, Mega WM, et al. Immunization with a recombinant, pseudomonas fluorescens-expressed, mutant form of Bacillus anthracis-derived protective antigen protects rabbits from anthrax infection. Plos One. 2015;10(7):e0130952.
   PubMed Web of Science ®Google Scholar
• Bode C, Zhao G, Steinhagen F, Kinjo T, Klinman DM. CpG DNA as a vaccine adjuvant. Expert Rev Vaccines. 2011 Apr; 10(4):499–511. doi:10.1586/erv.10.174.
   PubMed Web of Science ®Google Scholar