OL LI { The ACIP guidelines note that recommendations regarding pre-exposure vaccination should be based on a calculable risk assessment. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Anthim may also be used to prevent inhalational anthrax when other therapies are not available or appropriate. } 2007;(1):CD000975. Biron B, Beck K, Dyer D, et al. .strikeThrough { Cangene Corporation. A bioterrorism attack using anthrax spores is a possibility. Aetna considers intravenous anthrax immune globulin experimental and investigational for the treatment of systemic anthrax soft tissue infection related to drug injection because of insufficient evidence of its safety and effectiveness. Centers for Disease Control and Prevention (CDC), National Center for Infectious Diseases, Division of Bacterial and Mycotic Diseases. The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria. Rabbits and monkeys were exposed to a lethal aerosolized dose of B. anthracis spores, then treated with human anthrax immune globulin or a placebo, and evaluated for survival. These researchers conducted a systematic review of anti-toxin treatment of inhalation anthrax in humans and experimental animals to inform anti-toxin recommendations during a large-scale or mass anthrax incident. list-style-type: lower-alpha; } The following discussion is based primarily on guidelines on use of anthrax vaccine from the Advisory Committee on Immunization Practices (ACIP) and information on anthrax from the Centers for Disease Control and Prevention (CDC). Ales NC, Katial RK. More animals treated with obiltoxaximab lived compared to animals treated with placebo. Among human cases, addition of anti-toxin to combination anti-microbial treatment was associated with survival in 2 of the 3 cases treated. The FDA concluded that the results of studies in research animals provided sufficient evidence that human anthrax immune globulin is reasonably likely to benefit humans with inhalational anthrax (FDA, 2015). Guidelines for the Surveillance and Control of Anthrax in Humans and Animals. More animals treated with Anthim lived compared to animals treated with placebo. According to the ACIP guidelines, if concern exists that persons entering an area of a previous release might be at risk for exposure from a re-release of a primary aerosol of the organism or exposure from a high concentration of settled spores in a specific area, initiation of prophylaxis should be considered with antibiotics alone or in combination with vaccine as is outlined in the section below on post-exposure prophylaxis. The most commonly observed side effects were headache, back pain, nausea and infusion site pain and swelling. However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to outweigh this risk. MMWR Morb Mortal Wkly Rep. 2002;51(45):1024-1026. Toxins (Basel). } See your physician if you develop a sore or lesions after handling vaccine or livestock. The risk for persons who come in contact in the workplace with imported animal hides, furs, bone meal, wool, animal hair, or bristles has been reduced by changes in industry standards and import restrictions. text-decoration: line-through; AIG-IV recipients had surgery more often and, among survivors, had longer hospital stays than did non-recipients; AIG-IV recipients were sicker than non-recipients. Because of concern about the possible antibiotic resistance of Bacillus anthracis used in a bioterrorist attack, the ACIP guidelines state that doxycycline or ciprofloxacin can be chosen initially for antibiotic chemoprophylaxis until organism susceptibilities are known. Efficacy of ETI-204 monoclonal antibody as an adjunct therapy in a New Zealand white rabbit partial survival model for inhalational anthrax. FDA approves new treatment for inhalation anthrax. In: Immunisation Against Infectious Disease - 'The Green Book' - 2006 updated edition. Which single antibiotic or combination of antibiotics will be most effective for you depends on how you were infected with anthrax, your age, your overall health and other factors. Clin Infect Dis. Certain regions of the world (South and Central America, Southern and Eastern Europe, Asia, Africa, the Caribbean, and the Middle East) report more anthrax in animals than others. BioDrugs. Several studies have demonstrated that short courses (5 to 10 days) of post-exposure antibiotic therapy are not effective at preventing disease when large numbers of spores are inhaled. } Vaccine. Footnotes* Note: In general, Aetna does not cover immunizations required solely for the purpose of employment, or because of incarceration. Pediatrics. ol.numberedList LI { With delayed treatment, anti-toxin-antimicrobial treatment increased rabbit survival. OL OL LI { Silver Spring, MD: FDA; March 25, 2015. In a pre-event setting, in which the risk for exposure to aerosolized B. anthracis spores is presumably low, vaccination of pregnant women is not recommended and should be deferred until after pregnancy. MMWR Recomm Rep. 2000;49(RR-15):1-20. Antitoxin treatment of inhalation anthrax: A systematic review. Without treatment, more than half of patients with gastrointestinal anthrax die. (2) Injection anthrax was recently added as another type of anthrax … The anthrax vaccine is made by BioPort Corp. (Lansing, MI), which is awaiting U.S. FDA approval to resume shipping the vaccine. Questionable efficacy of therapeutic antibodies in the treatment of anthrax. The ACIP does state that pre-exposure vaccination may be indicated for the military, decontamination personnel, and other select populations or for groups for which a calculable risk can be assessed. After several days, the symptoms may progress to severe breathing problems and shock. This vaccine is given by injection by a health care professional. list-style-type: upper-alpha; When anthrax affects humans, it is usually due to an occupational exposure to infected animals or their products. On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. More animals treated with raxibacumab lived compared to animals treated with placebo; 64 % of animals in the monkey study and 44 % of animals in 1 rabbit study receiving the 40 mg/kg dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups. Options other than pre-exposure vaccination are available to protect personnel working in an area of a known previous release of Bacillus anthracis. The standard treatment for anthrax is a 60-day course of an antibiotic, such as ciprofloxacin (Cipro) or doxycycline (Monodox, Vibramycin, others). Huang E, Pillai SK, Bower WA, et al. By the later stages of the disease… Ann Intern Med. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone. Hendricks KA, Wright ME, Shadomy SV, et al; Workgroup on Anthrax Clinical Guidelines. Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis. Direct person-to-person spread of anthrax is extremely unlikely to occur. 13, pp. Bioterrorism alleging use of anthrax and interim guidelines for management - United States, 1998. However, the study suggests a possible benefit of post-exposure combination of antibiotics with vaccination. Raxibacumab is the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. Emerg Infect Dis. FDA News. Injection anthrax can spread throughout the body faster and be harder to recognize and treat. The ACIP guidelines recommend post-exposure anthrax vaccination for the following indications: Note: Medically necessary post-exposure anthrax vaccinations are covered for medically necessary indications regardless of whether the member has preventive services benefits. Military personnel deployed to areas with high-risk for exposure to the organism (as when it is used as a biological warfare weapon). Workers who are exposed to dead animals and animal products from other countries where anthrax is more common may become infected with Bacillus anthracis (B. anthracis; industrial anthrax). Use of anthrax vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2019. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site. ACIP recommends routine pre-exposure vaccination only for persons in this group for whom these standards and restrictions are insufficient to prevent exposure to anthrax spores. Anthrax toxins in the body cause severe illness. However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to out-weigh this risk. Survival in anthrax-infected monkeys treated with anthrax immune globulin ranged from 36 to 70 percent compared to 0 percent survival in the placebo group with a trend toward increased survival at higher doses of anthrax immune globulin. Injection anthrax occurs when the bacteria or spores are directly injected into the body. Biron et al (2015) stated that the B. anthracis anti-toxin monoclonal antibody (MAb) ETI-204 is a high-affinity chimeric de-immunized antibody that targets the anthrax toxin protective antigen (PA). A comprehensive search of 11 databases and the FDA website was conducted to identify relevant animal studies and human reports: 28 animal studies and 3 human cases were identified. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Available at: http://www.cdc.gov/ncidod/dbmd/diseaseinfo/anthrax_g.htm. In addition, studies suggest an extremely low-risk for exposure related to secondary aerosolization of previously settled Bacillus anthracis spores. Inhalation, ingestion, and injection anthrax, as well as anthrax meningitis are less common. 2012;156(1 Pt 1):41-44. 2018;9(5). Death rates did not differ significantly between recipients and non-recipients (33 % versus 21 %). King JC Jr, Gao Y, Quinn CP, et al. Which single antibiotic or combination of antibiotics will be most effective for you depends on how you were infected with anthrax, your age, your overall health and other factors. Anthrax vaccine: A review. In Scotland, the 2009 outbreak of Bacillus anthracis infection among persons who inject drugs resulted in a 28% death rate. /* aetna.com standards styles for templates */ color: red Systemic reactions occur in fewer than 0.2 % of recipients. In 2001, a U.S. military researcher mailed envelopes containing anthrax spores to members of Congress and the media. Overall, the results from this study indicated that a sub-therapeutic regimen consisting of an antibiotic in combination with an anti-PA MAb results in increased survival compared to the antibiotic alone and would provide an effective therapeutic strategy against symptomatic anthrax in non-vaccinated individuals. N Engl J Med. } Update: Investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. No studies have been published regarding use of anthrax vaccine among pregnant women. Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis. Grabenstein JD. Lesions have been found in the intestines and in the mouth and throat. World Health Organization (WHO), Emerging and Other Communicable Diseases, Surveillance and Control. Raxibacumab’s effectiveness for inhalational anthrax was demonstrated in 1 study in monkeys and 3 studies in rabbits. In some cases, treatment with monoclonal antibodies — raxibacumab and obiltoxaximab Huang et al (2015) noted that clinical guidelines for the treatment of anthrax recommend anti-toxin therapy in combination with intravenous anti-microbials; however, a large-scale or mass anthrax incident may exceed anti-toxin availability and create a need for judicious anti-toxin use. Following detection of PA in the blood, NZW rabbits were administered either an antibiotic (doxycycline) alone or the antibiotic in conjunction with ETI-204. Injection anthrax causes infection deep under the skin or in muscle. Respir Care Clin N Am. } Initial signs of nausea, loss of appetite, vomiting, and fever are followed by abdominal pain, vomiting of blood, and severe diarrhea. Aetna considers anthrax immunization a medically necessary preventive service for indications recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP). Obstet Gynecol. list-style-type: decimal; Currently, ciprofloxacin is the only antibiotic approved by the FDA for use in reducing the incidence or progression of disease after exposure to aerosolized Bacillus anthracis. Human anthrax immune globulin is manufactured from the plasma of individuals vaccinated against anthrax. MMWR Recomm Rep. 2019;68(4);1-14. Reuters Medical News, October 29, 2001. Recently, surgical removal of infected tissue has been used successfully to treat injection anthrax. Use of anthrax vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. The ACIP guidelines recommend anthrax vaccine as a component of post-exposure prophylaxis in pregnant women exposed to aerosolized B. anthracis spores. J Pediatric Infect Dis Soc. On the basis of studies that demonstrated the effectiveness of ciprofloxacin in reducing the incidence and progression of inhalation anthrax in animal models, the FDA approved the use of ciprofloxacin following aerosol exposure to Bacillus anthracis spores to prevent development or progression of inhalation anthrax in humans. Centers for Disease Control and Prevention (CDC). padding: 10px; WHO/EMC/ZDI/98.6. Severe local reactions are infrequent and consist of extensive swelling of the forearm in addition to the local reaction. However, the ACIP guidelines note that vaccination might be indicated for veterinarians and other high-risk persons handling potentially infected animals in areas with a high incidence of anthrax cases. Atlanta, GA: CDC; October 1, 2001. An anthrax vaccine is available to military personnel and some members of the general public. Aetna considers post-exposure anthrax vaccination medically necessary according to the ACIP guidelines. Vaccines against biologic agents: Uses and developments. An estimated 83 % of human vaccines develop a vaccine-induced immune response after 2 doses of the vaccine and greater than 95 % develop a fourfold rise in antibody titer after 3 doses. This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. A three-dose series of anthrax vaccine 3. Stern EJ, Uhde KB, Shadomy SV, Messonnier N. Conference report on public health and clinical guidelines for anthrax. 2014;20(2). Anthrax in wild livestock has occurred in the United States. When the vaccine is used to treat unvaccinated people who have been exposed to anthrax, the schedule is compressed to three subcutaneous doses. This prevents super-imposing the adverse effects of the vaccine on the underlying illness or mistakenly attributing a manifestation of the underlying illness to the vaccine. According to the ACIP guidelines, breast-feeding is neither a precaution nor a contraindication to vaccination, and vaccination does not need to be deferred in a pre-event setting if the occupation of the breast-feeding mother poses a risk for exposure to B. anthracis. Vaccines for preventing anthrax. However, whereas only 8 (27 %) of 30 patients at low risk for death (admission sequential organ failure assessment score of 0 to 5) received AIG-IV, 7 (54 %) of the 13 patients at high risk for death (sequential organ failure assessment score of 6 to 11) received treatment. Swartz MN. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. We studied anthrax immune globulin intravenous (AIG-IV) use from a 2009–2010 outbreak of Bacillus anthracissoft tissue infection in injection drug users in Scotland, UK, and we compared findings from 15 AIG-IV recipients with findings from 28 nonrecipients. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. FDA News. Although the precise correlation between antibody titer and protection against disease is not clear, these studies of post-exposure vaccine regimens used in combination with antibiotics in non-human primates have consistently documented that 2 to 3 doses of vaccine were sufficient to prevent development of disease once antibiotics were discontinued. Bravata D M, Wang E, Holty J-E, et al. Because anthrax is considered to be a potential agent for use in biological warfare, the Department of Defense (DOD) has begun mandatory vaccination of all active duty military personnel who might be involved in conflict. Recognition and management of anthrax -- an update. Tournier JN, Rougeaux C, Biot FV, Goossens PL. Persons who handle potentially infected animal products in high-incidence areas. display: block; 2003;23(4):713-730. Solution should appear clear to opalescent, colorless to pale yellow to pale brownish-yellow that may contain few translucent-to-white proteinaceous particulates Discard vial if the solution is discolored or contains extraneous particles other than a few translucent-to-white, proteinaceous particles Do not shake the vial Wright JG, Quinn CP, Shadomy S, Messonnier N; Centers for Disease Control and Prevention (CDC). If infection occurs, treatment is with antibiotics and possibly antitoxin. Communicability is not a concern in managing or visiting with patients with inhalational anthrax. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. With early treatment, survival did not differ between anti-microbial monotherapy and anti-microbial-antitoxin therapy in non-human primates and rabbits. The FDA’s Animal Rule allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. Anthrax pre-exposure prophylaxis consists of 2 intramuscular injections given 4 weeks apart followed by 3 additional subcutaneous injections given at 6, 12, and 18 months. For people who have been exposed to anthrax (but have no symptoms of the disease), providers may prescribe preventive antibiotics, such as ciprofloxacin, penicillin, or doxycycline, depending on the strain of anthrax. On December 14, 2012, FDA approved raxibacumab injection to treat inhalational anthrax. Silver Spring, MD: FDA; December 14, 2012. The anthrax vaccine is manufactured and distributed by BioPort, Corporation (Lansing, MI). Cynomolgus macaques were treated at the time of a positive serum electrochemiluminescence (ECL) assay for B. anthracis PA at a mean time of approximately 40 hours post-challenge with B. anthracis. Inhalation anthrax is usually fatal. The guidelines explain that, at present, the target population for a bioterrorist release of Bacillus anthracis can not be predetermined, and the risk of exposure can not be calculated. Virtually all the U.S. stockpile of the vaccine is under the control of the Pentagon, which has long worried that its soldiers will face enemy use of anthrax on the battlefield. London, UK: Department of Health; 2007; Ch. In addition, HMO plans usually exclude coverage of immunizations solely for the purpose of travel. The case fatality rate for cutaneous anthrax is estimated to be 20% without antibiotic treatment. These include South and Central America, Southern and Eastern Europe, Asia, Africa, the Caribbean, and the Middle East. Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis. 2019;4(3). Vaccine. list-style-type: upper-roman; Symptoms include redness and swelling at the injection site. The vaccine is reported to be 93 % effective in protecting against anthrax. Persons who work with imported animal hides or furs in areas where standards are insufficient to prevent exposure to anthrax spores. O'Leary ST, Kimberlin DW. Update from the Advisory Committee on Immunization Practices. Available at: http://www.anthrax.osd.mil/. Anthrax is most common in agricultural regions where it occurs in animals. Howdieshell TR, Heffernan D, Dipiro JT; Therapeutic Agents Committee of the Surgical Infection Society. Tao P, Mahalingam M, Zhu J, et al. Studies have demonstrated that antibiotics in combination with post-exposure vaccination are effective at preventing disease in nonhuman primates after exposure to Bacillus anthracis spores. list-style-type: lower-roman; U.S. Food and Drug Administration (FDA).  11/20/2020 2015;13(6):365-377. Responder units engaged in response activities that might lead to exposure to aerosolized, Following cutaneous or gastrointestinal exposure to, Activities with a high potential for aerosol production. Expert Opin Investig Drugs. Meaney-Delman D, Rasmussen SA, Beigi RH, et al. The ACIP recommends annual booster injections of the vaccine thereafter. 2006;7(3):275-303. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2006. Cui and colleagues (2017) studied anthrax immune globulin intravenous (AIG-IV) use from a 2009 to 2010 outbreak of Bacillus anthracis soft tissue infection in injection drug users in Scotland, UK, and compared findings from 15 AIG-IV recipients with findings from 28 non-recipients. Antimicrob Agents Chemother. No data suggest increased risk for side effects or temporally related adverse events associated with receipt of anthrax vaccine by breast-feeding women or breast-fed children. Anthrax is a potential bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air. padding-bottom: 4px; To prevent infection after being exposed to anthrax spores, the Centers for Disease Control and Prevention recommends: 1. In the event of biological warfare, chloramphenicol injection may be used to treat and prevent dangerous illnesses that are deliberately spread such as plague, tularemia, and anthrax of the skin or mouth. Although anaphylaxis following anthrax vaccination is extremely rare and no anaphylaxis deaths associated with Anthrax Vaccine Adsorbed (AVA) have been reported, this adverse event can be life-threatening. BioThrax does not contain live or killed forms of the bacteria that cause anthrax. Treatment is most effective when started as soon as possible. For additional language assistance: Anthrax vaccine, for subcutaneous or intramuscular use, Contact with and (suspected) exposure to anthrax. 2001;345(22):1621-1626. The safety of the product was tested in 74 healthy human volunteers (FDA, 2015). An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves new treatment for inhalation anthrax, FDA: Approved Drugs: Questions and Answers. JAMA. WHO Doc. A two-months' course of antibiotics such as ciprofloxacin, levofloxacin, and doxycycline after exposure can also prevent infection. The authors concluded that whether AIG-IV treatment is effective for systemic anthrax soft tissue infection related to drug injection cannot be answered with currently available data. width: 100%; Little SF. Initial therapy includes treatment with empirical antibiotics and appropriate supportive therapy. The FDA stopped production at BioPort in 1998 because of quality concerns. “As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. The standard treatment for anthrax is a 60-day course of an antibiotic, such as ciprofloxacin (Cipro) or doxycycline (Monodox, Vibramycin, others). U.S. Department of Defense (DoD). 2008;46(1):129-136. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death. Last Review 11/20/2020. list-style-type : square !important; Bower WA, Schiffer J, Atmar RL, et al. For cutaneous anthrax the figure is approximately 5% (10) and for injection anthrax currently around 30% (22). Time from B. anthracis exposure to symptoms or hospitalization and skin and limb findings at presentation did not differ between nonsurvivors and survivors. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. The site is secure. Aetna considers intravenous human anthrax immune globulin (Anthrasil) medically necessary to treat persons with inhalational anthrax in combination with appropriate antibacterial drugs. Anthrax is diagnosed by isolating B. anthracis from the blood, skin lesions, or respiratory secretions or by measuring specific antibodies in the blood of persons with suspected cases. #closethis { Cutaneous and rare gastrointestinal exposures of humans are possible following outbreaks of anthrax in livestock. Injection anthrax has not been reported in the United States. --> Treating providers are solely responsible for medical advice and treatment of members. 2017;6(4):311-316. Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices. The intestinal disease form of anthrax may follow the consumption of contaminated meat and is characterized by an acute inflammation of the intestinal tract. Talk to your doctor about the risks of using this medication for your condition. Anthrax vaccine precipitated induces edema toxin-neutralizing, edema factor-specific antibodies in human recipients. Before sharing sensitive information, make sure you're on a federal government site. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: A randomized, double-blinded, controlled, multicenter trial. Bush LM, Perez MT. On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Recently, another type of anthrax infection has been identified in heroin-injecting drug users in northern Europe. Although the shortened vaccine regimen has been effective when used in a post-exposure regimen that includes antibiotics, the duration of protection from vaccination is not known. Clindamycin may be added for its anti-exotoxin effect. Vaccines for preventing anthrax. Drugs.com provides accurate and independent information on more than 24,000 … On March 18, 2016, the FDA approved obiltoxaximab (Anthim) injection for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs. The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease, respectively. Update from the Advisory Committee on Immunization Practices. pii: 07-0969. Emerg Infect Dis. Although post-exposure chemoprophylaxis using antibiotics alone has been effective in animal models, the definitive length of treatment is unclear. In addition, ciprofloxacin and ofloxacin have also demonstrated in- vitro activity against Bacillus anthracis. Despite the paucity of human data, limited animal data suggested that adjunctive anti-toxin therapy may improve survival. Most cases are mild and go away with treatment. Deaths are rare with appropriate anti-microbial therapy. MMWR Recomm Rep. 2010;59(RR-6):1-30. If you’ve been exposed to anthrax and have symptoms, your doctor will treat you with antibiotics for 60 to 100 days . Med Microbiol Immunol. The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). Early initiation of antibiotic treatment is the most important factor in prognosis. The ACIP does not recommend routine vaccination of veterinarians in the United States because of the low incidence of animal cases.

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