Search

Tropical splenomegaly is often associated with malaria and schistosomiasis. In 2014 and 2015, 145 Congolese refugees in western Uganda diagnosed with splenomegaly during predeparture medical examinations underwent enhanced screening for various etiologies. After anecdotal reports of unresolved splenomegaly and complications after U.S. arrival, patients were reassessed to describe long-term clinical progression after arrival in the United States. Post-arrival medical information was obtained through medical chart abstraction in collaboration with state health partners in nine participating states. We evaluated observed splenomegaly duration and associated clinical sequelae between 130 case patients from eastern Congo and 102 controls through adjusted hierarchical Poisson models, accounting for familial clustering. Of the 130 case patients, 95 (73.1%) had detectable splenomegaly after arrival. Of the 85 patients with records beyond 6 months, 45 (52.9%) had persistent splenomegaly, with a median persistence of 14.7 months (range 6.0–27.9 months). Of the 112 patients with available results, 65 (58.0%) patients had evidence of malaria infection, and the mean splenomegaly duration did not differ by Plasmodium species. Refugees with splenomegaly on arrival were 43% more likely to have anemia (adjusted relative risk [aRR]: 1.43, 95% CI: 1.04–1.97). Those with persistent splenomegaly were 60% more likely (adjusted relative risk [aRR]: 1.60, 95% CI: 1.15–2.23) to have a hematologic abnormality, particularly thrombocytopenia (aRR: 5.53, 95% CI: 1.73–17.62), and elevated alkaline phosphatase (aRR: 1.57, 95% CI: 1.03–2.40). Many patients experienced persistent splenomegaly, contradicting literature describing resolution after treatment and removal from an endemic setting. Other possible etiologies should be investigated and effective treatment, beyond treatment for malaria and schistosomiasis, explored.

In this commentary, we briefly describe our methodology in conducting a remote qualitative investigation with essential workers from southwest Kansas, and then describe some key considerations, challenges, and lessons learned in recruiting and conducting interviews remotely. From August 4, 2020 through August 26, 2020, Centers for Disease Control and Prevention (CDC) staff conducted five phone interviews with culturally and linguistically diverse employees in southwest Kansas to understand COVID-19 knowledge, attitudes, and practices and communication preferences. Our experience details the potential challenges of the federal government in recruiting individuals from these communities and highlights the possibilities for more effectively engaging health department and community partners to support investigation efforts. Optimizing recruitment strategies with additional participation from community partners, developing culturally and linguistically appropriate data collection tools, and providing supportive resources and services may augment participation from refugee, immigrant, and migrant (RIM) communities in similar remote investigations.

Colleges are at risk for communicable disease outbreaks because of the high degree of person-to-person interactions and relatively crowded dormitory settings. This report describes the US college student health screening requirements among US resident and international students for tuberculosis (TB) and vaccine-preventable diseases (VPDs) as they relate to the American College Health Association (ACHA) guidelines. Methods/Participants: In April 2012, US college health administrators (N = 2,858) were sent online surveys to assess their respective school's TB screening and immunization requirements.Surveys were completed by 308 (11%) schools. Most schools were aware of the ACHA immunization (78%) and TB screening (76%) guidelines. Schools reported having policies related to immunization screening (80.4%), immunization compliance (93%), TB screening (55%), and TB compliance (87%).Most colleges were following ACHA guidelines. However, there are opportunities for improvement to fully utilize the recommendations and prevent outbreaks of communicable diseases among students in colleges.

The current global refugee crisis involves 65.3 million persons who have been displaced from their homes or countries of origin. While escaping immediate harm may be their first priority, displaced people go on to face numerous health risks, including trauma and injuries, malnutrition, infectious diseases, exacerbation of existing chronic diseases, and mental health conditions. This crisis highlights the importance of building capacity among health-care providers, scientists, and laboratorians to understand and respond to the health needs of refugees. The November 2016 American Society of Tropical Medicine and Hygiene (ASTMH) conference in Atlanta will feature an interactive exhibit entitled “The Refugee Journey to Wellbeing” and three symposia about refugee health. The symposia will focus on tropical disease challenges in refugee populations, careers in refugee health, and recent experiences of governmental agencies and nongovernmental organizations in responding to the global refugee crisis. We invite ASTMH attendees to attend the exhibit and symposia and consider contributions they could make to improve refugee health through tropical disease research or clinical endeavors.

Summary Background In 2011, the Centers for Disease Control and Prevention modified its 2008 protocol for flight-related tuberculosis contact investigation initiation. The 2011 Modified protocol was implemented and replaced the 2008 CDC protocol based on comparative epidemiologic and economic analyses; this publication reports the economic analysis results. Methods A return on investment model compared relative changes in tuberculosis disease treatment costs resulting from expenditures on tuberculosis contact investigations and latent tuberculosis infection treatment for the 2008 CDC and Modified protocols. Results At moderate/high rates of latent tuberculosis infection and tuberculosis disease, positive returns on investment indicated each $1.00 spent on tuberculosis contact investigations and latent tuberculosis treatment resulted in more than $1.00 of savings from reduced tuberculosis disease treatment costs. Low rates of latent tuberculosis infection and tuberculosis disease resulted in negative returns on investment, indicating economic losses from tuberculosis disease treatment costs. There were smaller economic losses at low latent tuberculosis infection and tuberculosis disease rates with the Modified protocol in comparison to the 2008 CDC protocol, while both identified comparable numbers of persons at risk for tuberculosis. Conclusion The Modified protocol for conducting flight-related tuberculosis contact investigations represents a better use of resources and protects public health.

Background Persons born in countries with hepatitis B surface antigen (HBsAg) prevalence ≥2% have increased risk for unrecognized hepatitis B virus (HBV) infection. Testing at pre-travel consultations is a strategy to identify previously undiagnosed HBV infections. Using records of travelers seen at the Boston Area Travel Medicine Network (BATMN) sites, we assessed how these travel clinics currently assess HBV status, describe test results, and describe characteristics of those tested and immunized for HBV. Methods Demographic data and trip information were collected for all travelers seen at the BATMN sites from June 2008 through July 2010. Proportions of those tested for HBV were determined, and differences between those tested and not tested were analyzed. Results Among 13,732 travelers enrolled during the study period, 2,134 (16%) were born in HBV-risk countries (HBsAg prevalence ≥2%); 532/2134 (25%) had previous HBV test results and 230 (11%) had tests performed at the travel clinic visit. Past results showed that 33/453 (7.3%) were HBV-infected (HBsAg+), 252/481 (52.4%) were immune (anti-HBs+, HBsAg–), 164/303 (54.1%) were susceptible (anti-HBs–, HBsAg–, anti-HBc–), and 38/314 (12.1%) had possible HBV exposure (anti-HBc+, HBsAg–, anti-HBs–). Among 230 travelers tested during the travel clinic visit, 7/213 (3.3%) were HBV-infected, 95/218 (43.6%) were immune, 106/179 (59.2%) were susceptible, and 10/182 (5.5%) had possible HBV exposure. Conclusion The travel clinic offers an opportunity to capture, identify, and educate infected persons unaware of their infection, educate those with known results, and initiate preventive action (eg, vaccination) for those still susceptible.

During the 2008 Olympic and Paralympic Games, we conducted surveillance of illnesses among travelers at six Beijing clinics. Surveys asked about demographic, pre-travel, and vaccination information, and physician-provided diagnoses. Of 807 respondents, 38% and 57% were classified as foreign visitors (FV) and expatriates, respectively. Less than one-half of FV sought pre-travel advice; sources included health-care providers and friends/family. FV vaccination rate was also low; however, most vaccines given were recommended by the Centers for Disease Control and Prevention. The most common FV diagnoses were respiratory, injury/musculoskeletal, and gastrointestinal illnesses; for expatriates, injury/musculoskeletal, respiratory, and dermatologic were the most common illnesses. Respiratory illnesses in expatriates were significantly less in 2008 than during 2004-2007 (chi(2) = 10.2; P = 0.0014), suggesting that control programs may have reduced pollutants/respiratory irritants during the 2008 Games. We found no previous studies of health outcomes among expatriates living in cities with mass travel events. These findings highlight the need to continuously disseminate information to health-care providers advising travelers.

A fundamental role of the veterinary profession is the protection of human health through wholesome food and control of diseases of animal origin, especially zoonoses. Therefore, training of veterinary students worldwide needs to face the new challenges posed by emerging infections, both from wildlife and domestic animals, as well as risks from bio/agroterrorism. New courses emphasising recognition, response, recovery and prevention must be developed to respond to natural or intentionally induced emerging diseases and zoonoses. Training programmes in applied epidemiology, zoonoses and foreign animal diseases are crucial for the development of a strong workforce to deal with microbial threats. Students should learn the reporting pathways for reportable diseases in their countries or states. Knowledge of the principles of ecology and ecosystems should be acquired during pre-veterinary studies. Elective classes on wildlife diseases, emphasising wildlife zoonotic diseases, should be offered during the veterinary curriculum, as well as a course on risk communication, since veterinarians are frequently in the position of having to convey complex information under adverse circumstances.

Yellow fever (YF) vaccine has been used for prevention of YF since 1937 with over 500 million doses administered. However, rare reports of severe adverse events following vaccination have raised concerns about the vaccine's safety. We reviewed reports of adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2000 to 2006. We used estimates of age and sex distribution of administered doses obtained from a 2006 survey of authorized vaccine providers to calculate age- and sex-specific reporting rates of all serious adverse events (SAE), anaphylaxis, YF vaccine-associated neurotropic disease, and YF vaccine-associated viscerotropic disease. Reporting rates of SAEs were substantially higher in males and in persons aged > or =60 years. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of physician and traveler education regarding the risks and benefits of YF vaccination, particularly for travelers > or =60 years of age. Vaccination should be limited to persons traveling to areas where the risk of YF is expected to exceed the risk of serious adverse events after vaccination, or if not medically contraindicated, where national regulations require proof of vaccination to prevent introduction of YF.

A 12-month, population-based, case-control study of Campylobacter infections was conducted at Foodborne Disease Active Surveillance Network surveillance areas during 1998-1999. Of 858 Campylobacter isolates tested for antimicrobial susceptibility to the fluoroquinolone ciprofloxacin, 94 (11%) were resistant. Travel outside of the United States was reported by 27 (42%) of 64 patients with fluoroquinolone-resistant Campylobacter infection and by 51 (9%) of 582 patients with fluoroquinolone-susceptible Campylobacter infection (odds ratio [OR], 7.6; 95% confidence interval [CI], 4.3-13.4). When patients with domestically acquired fluoroquinolone-resistant Campylobacter infection were compared with matched healthy control subjects in a multivariate analysis, those infected were 10 times more likely to have eaten chicken or turkey cooked at a commercial establishment (18 [55%] of 33 case patients vs. 7 [21%] of 33 controls; matched OR, 10.0; 95% CI, 1.3-78). Although travel outside of the United States was associated with fluoroquinolone-resistant Campylobacter infection, most infections among study participants were domestically acquired. This study provides additional evidence that poultry is an important source of domestically acquired fluoroquinolone-resistant Campylobacter infection. Control measures should include efforts to improve food handling in commercial establishments.

On 20 December 2001, the Centers for Disease Control and Prevention (CDC) initiated the Anthrax Vaccine and Antibiotic Availability Program (hereafter, the "Program") under an investigational new drug application with the US Food and Drug Administration. This Program provided options for additional preventive treatment for persons at risk for inhalation anthrax as a result of recent bioterrorism attacks who had concluded or were concluding a 60-day course of antimicrobial prophylaxis. Participants were offered an additional 40 days of antibiotic therapy (with ciprofloxacin, doxycycline, or amoxicillin) or antibiotic therapy plus 3 doses of anthrax vaccine. By 11 February 2002, a total of 5420 persons had received standardized education about the Program and 1727 persons (32%) had enrolled. Twelve participants have been identified as having serious adverse events (SAEs). One SAE, which occurred in a participant with ciprofloxacin-induced allergic interstitial nephritis, was considered to be probably associated with treatment received in the Program. No SAEs were associated with anthrax vaccine. CDC will continue to monitor Program participants during the next 2 years.

Adventure travel is becoming more popular, increasing the likelihood of contact with unusual pathogens. We investigated an outbreak of leptospirosis in “Eco-Challenge” multisport race athletes to determine illness etiology and implement public health measures. Of 304 athletes, we contacted 189 (62%) from the United States and 26 other countries. Eighty (42%) athletes met our case definition. Twenty-nine (36%) case-patients were hospitalized; none died. Logistic regression showed swimming in the Segama River (relative risk [RR]=2.0; 95% confidence interval [CI]=1.3 to 3.1) to be an independent risk factor. Twenty-six (68%) of 38 case-patients tested positive for leptospiral antibodies. Taking doxycycline before or during the race was protective (RR=0.4, 95% CI=0.2 to 1.2) for the 20 athletes who reported using it. Increased adventure travel may lead to more frequent exposure to leptospires, and preexposure chemoprophylaxis for leptospirosis (200 mg oral doxycycline/week) may decrease illness risk. Efforts are needed to inform adventure travel participants of unique infections such as leptospirosis.

Organisms, including Vibrio cholerae, can be transferred between harbors in the ballast water of ships. Zones in the Caribbean region where distance from shore and water depth meet International Maritime Organization guidelines for ballast water exchange are extremely limited. Use of ballast water treatment systems could mitigate the risk for organism transfer.

After recreational exposure to river water in Uganda, 12 (17%) of 69 persons had evidence of schistosome infection. Eighteen percent self-medicated with praziquantel prophylaxis immediately after exposure, which was not appropriate. Travelers to schistosomiasis-endemic areas should consult a travel medicine physician.

The annual Hajj pilgrimage of more than 2.5 million pilgrims from more than 160 countries is held in the Kingdom of Saudi Arabia (KSA) ( 1 ) (see the figure). Hajj is a deeply spiritual journey undertaken by Muslims at least once in their lifetimes. Hajj-related infectious disease outbreaks in recent decades have focused attention on Hajj as a global public health security challenge of extraordinary dimensions ( 1 – 5 ). This past summer, a KSA–World Health Organization (WHO) consultation process developed the Jeddah recommendations on mitigation for the effects of the current pandemic influenza A (H1N1) virus during the 2009 Hajj, which is the last week of November ( 6 ). Here, we outline some of the realities associated with meeting those recommendations and the most recent plans to help mitigate the transmission burden.

Guest Editors: Nina Marano (Figure 1), Paul Arguin (Figure 2), Marguerite Pappaioanou (Figure 3), and Jay C. Butler (Figure 4). Figure 1 Guest editor Nina Marano. Dr Marano is the chief of the Geographic Medicine and Health Promotion Branch in the Division of Global Migration and Quarantine at CDC. The branch mission is to protect the health of US travelers at home and abroad and to prevent ... Figure 2 Guest editor Paul Arguin. Dr Arguin is the chief of the Domestic Response Unit in the Malaria Branch within the National Center for Zoonotic, Vectorborne, and Enteric Diseases at CDC. Figure 3 Guest editor Marguerite Pappaioanou. Dr Pappaioanou is professor of infectious disease epidemiology in the School of Public Health with a joint appointment in the College of Veterinary Medicine at the University of Minnesota. Her areas of interest are ... Figure 4 Guest editor Jay C. Butler. Dr Butler is on detail from CDC to the Alaska Division of Public Health, where he is deputy director for science and medicine and is the state epidemiologist. His research interests include vaccine-preventable diseases, antimicrobial ... Snakes on a Plane was poised to be the blockbuster movie of the 2006 summer season. It featured reptiles smuggled onto an airplane as an unusual bioweapon of mass destruction. In a much less dramatic fashion, this absurd scenario plays out every day, when tons of live animals and unprocessed animal products are shipped internationally around the globe, providing many opportunities for rapidly translocating zoonotic pathogens. Episodes of emerging zoonoses are being increasingly recognized around the world. From 1996 to 2004, some 21% of 10,490 reports of animal diseases from 191 countries submitted to the Program for Monitoring Emerging Diseases (ProMED) concerned humans affected by zoonotic disease (1). This zoonoses theme issue of Emerging Infectious Diseases (EID) corroborates this finding, presenting reports of zoonotic disease from all corners of the globe, including the People's Republic of China, Vietnam, Slovakia, Indonesia, the United States, Israel, Bangladesh, the Netherlands, Brazil, Algeria, India, the Democratic Republic of the Congo, and Italy. As public health and animal health organizations attempt to respond to these emerging and reemerging zoonotic diseases, their ability and skill in forming new strategic partnerships are of paramount importance. This year was highlighted by the establishment of the Centers for Disease Control and Prevention (CDC) as a World Organization for Animal Health (OIE) Collaborating Center for Emerging and Remerging Zoonoses. To initiate this collaborating center, the International Symposium on Emerging Zoonoses (ISEZ) was held in conjunction with the International Conference on Emerging Infectious Diseases and the International Conference on Women and Infectious Diseases in Atlanta in March 2006. ISEZ was cosponsored by OIE, the United Nations Food and Agriculture Organization, the US Department of Agriculture Animal and Plant Health Inspection Service, the Department of Interior US Geological Survey, National Wildlife Health Center, the World Health Organization, and CDC. ISEZ was attended by >400 veterinarians, physicians, and public health professionals from all over the world. The objective of the symposium was to share information among public health and animal health professionals so that more effective and cooperative partnerships could be developed. In turn, this would help to better understand, prevent, and control new microbial dangers to human and animal health that occur globally every day. The 44 internationally renowned ISEZ speakers and moderators recognized the spirit in which this meeting was created. Their participation reflected a true commitment to the partnership between public health and animal health needed to meet the ever-growing microbial challenges threatening human, animal, and environmental health on a seemingly continual basis. The speakers lent their talent and expertise to the following themes: the epidemiology of pathogens and diseases shared among humans and animals, the risks of wildlife and exotic pet trade to human and animal health, the effects of agricultural practices on human and ecosystem health, the lessons learned from previous experiences, and collaborative achievements. Speakers offered solutions that had been tested through innovative, interdisciplinary, and intersectoral research to deal with the problems of emerging zoonoses. A few presentations are highlighted below. In his presentation, Emerging and Remerging Zoonoses from Wildlife Reservoirs to Exotic Pets, Bruno Chomel, University of California, Davis, College of Veterinary Medicine, reminded participants that most emerging infectious diseases are zoonotic, with wildlife constituting a large and often unknown reservoir. Wildlife can also be a source for reemergence of previously eradicated zoonoses. The discovery of such zoonoses is often related to better diagnostic tools. However, human modification to natural wildlife habitats and human behavior, such as deforestation, which causes range expansion of the tick vector for Kyasanur Forest disease in India, also create opportunities for emergence of zoonotic diseases. Translocation of raccoon dogs from Asia into Europe has provided a new potential rabies reservoir. Human behavior includes sleeping with pets, reported by 30% of Americans, and keeping of exotic pets that provide opportunities for microbial transmission that have not existed until recently. More than 10,000 pet tigers are kept in the United States—more tigers than are currently living in the wild throughout the world. Thus, addressing human influences on ecosystems and behavior with regard to wild and exotic animals must be incorporated into efforts at preventing and controlling emerging diseases that involve wildlife and other valued natural resources. In her presentation, Combined Vaccination Delivery to Remote and Mobile Pastoral Families and Their Animals, Esther Schelling, Swiss Tropical Institute, focused on the potential of joining public health and veterinary services to achieve higher vaccination coverage in Africa's remote rural settings. Such sharing is aimed at reducing vaccine-preventable diseases in persons and their livestock. Her findings from Chad indicated that sharing transport logistics and cold chain equipment between the public health and veterinary sectors in the most remote areas reduced total program delivery costs, was highly valued by pastoralists, and was an important strategy to connect hard-to-reach populations with needed vaccinations such as for measles and polio for children and anthrax for livestock. By optimizing the use of limited logistic and human resources, public health and veterinary services were strengthened, especially at the district level, and, in turn, the services can become more prepared to respond to endemic and epidemic diseases. ISEZ participants learned about the impact of human behavior on emergence and subsequent spread of highly pathogenic avian influenza (HPAI) H5N1 strain in Asia from Vincent Martin of the Food and Agriculture Organization. Human behavior that supported disease emergence includes agriculture practices that allow species mixing, limited biosecurity to prevent mixing of domestic and wild animals, and a cultural preference for warm meat that has made live bird markets common in urban areas. These factors act synergistically with the intrinsic characteristics of the virus and the rapid evolution of animal and farming production systems in the region to support emergence. Martin emphasized that understanding the underlying farming practices and cultural preferences that influenced the emergence and spread of HPAI in developing countries has been instrumental in implementing effective risk reduction measures. The experience of fighting HPAI in Asia shows that control efforts should be focused on production sectors with low biosecurity standards and free-ranging chickens and ducks. Creating conditions that are not conducive to microbial selection and emergence represents a major challenge, from a disease management and cultural point of view, for reducing the risk for avian influenza occurrence and subsequent human infection. This issue of EID continues in the tradition of the 2 previous December theme issues by focusing on zoonoses, reminding readers again that we must maintain a vigilance in combatting these microbial threats. The issue highlights efforts directed at identifying disease reservoirs and finding better ways to understand, evaluate, prevent, and control disease transmission. At the same time, healthy ecosystems need to be promoted, economic livelihoods safeguarded, and cultural beliefs respected at household to national and international levels. Contained in this issue are articles based on the following ISEZ presentations: Review of Bats and SARS (2) and Ecologic Niche Modeling and Spatial Patterns of Disease Transmission (3). Also featured are articles that focus on the role of risk factors for introducing zoonotic diseases, such as monkeypox associated with domestic trade in certain animal species and human behavior as a risk factor for exposure to avian influenza in Vietnam. Many species of animals are highlighted, including cats colonized with methicillin-resistant Staphylococcus aureus, horses and wild mammals infected with West Nile virus, dogs with rickettsial infections, turkeys with human metapneumovirus, and nonhuman primates infected with malaria. We encourage our readers to continue to conduct and submit the findings of essential research on emerging zoonotic diseases to EID as we strive to share and disseminate this information to our multidisciplinary readership.

Shipping companies were surveyed to evaluate the effect of public health measures during the influenza A (H1N1) pandemic of 2009 on ship and port operations. Of 31 companies that operated 960 cruise, cargo, and other ships, 32% experienced health-screening measures by port health authorities. Approximately a quarter of ports (26%) performed screening at embarkation and 77% of shipping companies changed procedures during the early stage of the pandemic. Four companies reported outbreaks of pandemic influenza A (H1N1) 2009 on ships, which were ultimately stopped through infection control practices. Public health measures did not interfere substantially with port and ship operations with the exception of some port authorities that delayed embarking and disembarking procedures in a few ships. However, in the shipping companies' experience, measures were inconsistent between port health authorities. Access to antiviral drugs and pandemic vaccine was not provided in all ports. Current guidelines on medical care, hygiene, and emergency procedures on ships need to address pandemic influenza preparedness in future revisions.

The section listed above, written by members of the CDC's Division of Global Migration and Quarantine and focusing on globally mobile populations and infectious disease outbreaks, is freely available online only, in this issue of Clinical Infectious Diseases at (http://cid.oxfordjournals.org).

Exposure to animals can provide many benefits during the growth and development of children. However, there are potential risks associated with animal exposures, including exposure to nontraditional pets in the home and animals in public settings. Educational materials, regulations, and guidelines have been developed to minimize these risks. Pediatricians, veterinarians, and other health care professionals can provide advice on selection of appropriate pets as well as prevention of disease transmission from nontraditional pets and when children contact animals in public settings.

In 1999, the US Congress directed the Centers for Disease Control and Prevention to conduct a pivotal safety and efficacy study of anthrax vaccine adsorbed (AVA).To determine the effects on serological responses and injection site adverse events (AEs) resulting from changing the route of administration of AVA from subcutaneous (s.q.) to intramuscular (i.m.) and omitting the week 2 dose from the licensed schedule.Assessment of the first 1005 enrollees in a multisite, randomized, double-blind, noninferiority, phase 4 human clinical trial (ongoing from May 2002).Healthy adults received AVA by the s.q. (reference group) or i.m. route at 0, 2, and 4 weeks and 6 months (4-SQ or 4-IM; n = 165-170 per group) or at a reduced 3-dose schedule (3-IM; n = 501). A control group (n = 169) received saline injections at the same time intervals.Noninferiority at week 8 and month 7 of anti-protective antigen IgG geometric mean concentration (GMC), geometric mean titer (GMT), and proportion of responders with a 4-fold rise in titer (%4 x R). Reactogenicity outcomes were proportions of injection site and systemic AEs.At week 8, the 4-IM group (GMC, 90.8 microg/mL; GMT, 1114.8; %4 x R, 97.7) was noninferior to the 4-SQ group (GMC, 105.1 microg/mL; GMT, 1315.4; %4 x R, 98.8) for all 3 primary end points. The 3-IM group was noninferior for only the %4 x R (GMC, 52.2 microg/mL; GMT, 650.6; %4 x R, 94.4). At month 7, all groups were noninferior to the licensed regimen for all end points. Solicited injection site AEs assessed during examinations occurred at lower proportions in the 4-IM group compared with 4-SQ. The odds ratio for ordinal end point pain reported immediately after injection was reduced by 50% for the 4-IM vs 4-SQ groups (P.001). Route of administration did not significantly influence the occurrence of systemic AEs.The 4-IM and 3-IM regimens of AVA provided noninferior immunological priming by month 7 when compared with the 4-SQ licensed regimen. Intramuscular administration significantly reduced the occurrence of injection site AEs. Trial Registration clinicaltrials.gov Identifier: NCT00119067.

Purpose The CDC's Anthrax Vaccine and Antibiotic Availability Program was implemented under an Investigational New Drug (IND) application to provide additional post-exposure prophylaxis for individuals potentially exposed to Bacillus anthracis in the fall of 2001. Participants were provided with two options: (1) 40 additional days of antimicrobial prophylaxis (i.e., ciprofloxacin, doxycycline, or amoxicillin); or (2) 40 additional days of antimicrobial prophylaxis plus three doses of anthrax vaccine adsorbed (AVA). Methods Participants were monitored for adverse events (AEs). Participants were asked to complete 2-week AE diaries for 6 weeks post-enrollment, and approximately 2 months after enrollment, active surveillance was conducted through telephone interviews with 1113 (64%) participants. Results A total of 1727 of approximately 10 000 previously prophylaxed persons enrolled to receive 40 additional days of antibiotics. Of these, 199 opted at enrollment to receive three doses of AVA in addition to the additional 40 days of antibiotic. Overall, 28% of participants reported at least one AE on their diaries. Results varied by surveillance mechanism, the diary data indicated differences in the proportion reporting AEs between participants receiving antibiotic only and participants receiving antibiotic and AVA. However, during the active 2-month telephone follow-up, the rates of AEs reported for both the antibiotic only and antibiotic plus AVA treatment regimens were similar. Additionally, ciprofloxacin and doxycycline had similar AE profiles, with only rigors reported significantly more often among ciprofloxacin recipients. Conclusions Overall, the rates of AEs experienced by all participants were acceptable given the seriousness of potential B. anthracis exposure. Copyright © 2005 John Wiley & Sons, Ltd.