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PubMed2006

Training for terrorism-related conditions in hospitals: United States, 2003-04.

OBJECTIVE: This study estimates baseline data to determine which hospital characteristics are associated with providing terrorism preparedness training to clinical staff. METHODS: Information from a Bioterrorism and Mass Casualty Supplement to the 2003 and 2004 National Hospital Ambulatory Medical Care Surveys was used to provide national estimates of variations in terrorism preparedness training by eight hospital characteristics. Of 874 hospitals in scope, 739 (84.6 percent) responded. Estimates are presented with 95 percent confidence intervals. RESULTS: Hospitals with Joint Commission accreditation were more likely to provide terrorism preparedness training to all types of clinical staff (staff physicians, residents, nurse practitioners, physician assistants, and laboratory staff). Teaching hospitals, medical school affiliation, bed capacity, and urban location were also associated with training staff physicians, residents, nurse practitioners, and physician assistants. Hospitals with residency programs were associated with training only staff physicians and residents. There was more parity across hospital characteristics in training nurses and laboratory staff than for physicians, residents, nurse practitioners, and physician assistants. Joint Commission accreditation was the most consistent factor associated with providing training for all nine exposures studied (smallpox, anthrax, chemical and radiological exposures, botulism, plague, tularemia, viral encephalitis, and hemorrhagic fever).

Adult↗

PubMed2005

Adverse events associated with smallpox vaccination in the United States, January-October 2003.

CONTEXT: On January 24, 2003, the US Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a bioterrorism event. OBJECTIVE: To describe results from the comprehensive DHHS smallpox vaccine safety monitoring and response system. DESIGN, SETTING, AND PARTICIPANTS: Descriptive study of adverse event reports from the DHHS smallpox vaccine safety monitoring and response system received between January 24 and October 31, 2003, through the Vaccine Adverse Event Reporting System (VAERS) and the Centers for Disease Control and Prevention. A total of 37,901 volunteers in 55 jurisdictions received at least 1 dose of smallpox vaccine. MAIN OUTCOME MEASURES: Number of vaccinations administered and description of adverse events and reporting rates. RESULTS: A total of 38,885 smallpox vaccinations were administered, with a take rate of 92%. VAERS received 822 reports of adverse events following smallpox vaccination (overall reporting rate, 217 per 10,000 vaccinees). A total of 590 adverse events (72%) were reported within 14 days of vaccination. Nonserious adverse events (n = 722) included multiple signs and symptoms of mild and self-limited local reactions. One hundred adverse events (12%) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis and/or pericarditis and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized vaccinia and 1 case of postvaccinial encephalitis were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with vaccinia immune globulin were identified. Serious adverse events were more common among older revaccinees than younger first-time vaccinees. CONCLUSIONS: Rigorous smallpox vaccine safety screening, educational programs, and older vaccinees may have contributed to low rates of preventable life-threatening adverse reactions. Other rare, clinically significant, or unexpected cardiac adverse events were detected by timely review of VAERS data and intensive clinical case investigation.

Adverse Drug Reaction Reporting Systems↗

PubMed2005

Neurologic adverse events associated with smallpox vaccination in the United States, 2002-2004.

CONTEXT: Neurologic illness is an infrequent but severe adverse event associated with smallpox vaccination. The reinstatement of smallpox vaccination in the United States in response to possible bioterrorism renewed concerns about vaccine-related adverse neurologic events. OBJECTIVE: To determine rates and describe the clinical features of neurologic events associated with smallpox vaccination. DESIGN AND SETTING: We assessed reports of adverse events obtained through active case reporting and review of data reported to the Vaccine Adverse Event Reporting System among 665,000 persons vaccinated against smallpox by the Departments of Defense (n = 625,400 [corrected]) and Health and Human Services (n = 39,400 [corrected]) during the 2002-2004 US Smallpox Vaccination Program. MAIN OUTCOME MEASURE: Adverse neurologic events temporally associated with smallpox vaccination. RESULTS: Between December 16, 2002, and March 11, 2004, 214 neurologic adverse events temporally associated with smallpox vaccination were reported; 111 reports involved Department of Health and Human Services and 103 involved Department of Defense vaccinees. Fifty-four percent of these events occurred within 1 week of vaccination, and 53% were among primary vaccinees. The most common neurologic adverse event was headache (95 cases), followed by nonserious limb paresthesias (n = 17) or pain (n = 13) and dizziness or vertigo (n = 13). Serious neurologic adverse events included 13 cases of suspected meningitis, 3 cases of suspected encephalitis or myelitis, 11 cases of Bell palsy, 8 seizures (including 1 death), and 3 cases of Guillain-Barré syndrome. Among these 39 events, 27 (69%) occurred in primary vaccinees and all but 2 occurred within 12 days of vaccination. CONCLUSIONS: During the 2002-2004 smallpox vaccination campaign, reported neurologic events were generally mild and self-limited, and no neurologic syndrome was identified at a rate above baseline estimates. Serious neurologic adverse events, such as postvaccinal encephalitis, Bell palsy, and Guillain-Barré syndrome, occurred in accordance with expected ranges.

Adverse Drug Reaction Reporting Systems↗

PubMedDate not supplied

Detection of antigen-specific T cells on p/MHC microarrays.

The development of high-throughput protein microarrays for rapidly determining antigen-specific T-cell receptor repertoires of diverse T-cell populations can enable comprehensive, broad-based analyses of T-cell responses. Promising applications include medical diagnostics, vaccine development, treatment of autoimmune diseases and detection of potential agents of bioterrorism. In this study, we examined the feasibility of using peptide/major histocompatibility complex (p/MHC) microarrays to selectively capture and enumerate antigen-specific T cells. Results are presented for p/MHC microarrays consisting of a dimeric MHC-immunoglobulin complex, K(b)-Ig, loaded with either a cognate or non-cognate peptide for binding CD8(+) T cells. We quantified the sensitivity of these K(b)-Ig microarrays by measuring a lower detection limit of 0.05% antigen-specific CD8(+) T cells mixed with splenocytes from C57BL/6J mouse. A fivefold increase in this lower detection limit (0.01%) was achieved using a secondary capture anti-Ig antibody to coat the microarray surface. This higher sensitivity is comparable to that obtained using standard state-of-the-art fluorescence activated cell sorting (FACS) instruments. We also found that contacting the T-cell suspension with the K(b)-Ig microarrays under mild shear flow conditions produced more uniform distributions of captured T cells on the individual spots and better spot-to-spot reproducibility across the entire microarray.

Animals↗

PubMed2006

Anthrax vaccine powder formulations for nasal mucosal delivery.

Anthrax remains a serious threat worldwide as a bioterror agent. A second-generation anthrax vaccine currently under clinical evaluation consists of a recombinant Protective Antigen (rPA) of Bacillus anthracis. We have previously demonstrated that complete protection against inhalational anthrax can be achieved in a rabbit model, by intranasal delivery of a powder rPA formulation. Here we describe the preformulation and formulation development of such powder formulations. The physical stability of rPA was studied in solution as a function of pH and temperature using circular dichroism (CD), and UV-visible absorption and fluorescence spectroscopies. Extensive aggregation of rPA was observed at physiological temperatures. An empirical phase diagram, constructed using a combination of CD and fluorescence data, suggests that rPA is most thermally stable within the pH range of 6-8. To identify potential stabilizers, a library of GRAS excipients was screened using an aggregation sensitive turbidity assay, CD, and fluorescence. Based on these stability profiles, spray freeze-dried (SFD) formulations were prepared at pH 7-8 using trehalose as stabilizer and a CpG-containing oligonucleotide adjuvant. SFD formulations displayed substantial improvement in storage stability over liquid formulations. In combination with noninvasive intranasal delivery, such powder formulations may offer an attractive approach for mass biodefense immunization.

Administration, Intranasal↗

PubMed2004

Botulinum toxins in neurological disease.

Botulinum toxins are among the most potent neurotoxins known to humans. In the past 25 years, botulinum toxin has emerged as both a potential weapon of bioterrorism and as a powerful therapeutic agent, with growing applications in neurological and non-neurological disease. Botulinum toxin is unique in its ability to target peripheral cholinergic neurons, preventing the release of acetylcholine through the enzymatic cleavage of proteins involved in membrane fusion, without prominent central nervous system effects. There are seven serotypes of the toxin, each with a specific activity at the molecular level. Currently, serotypes A (in two preparations) and B are available for clinical use, and have been shown to be safe and effective for the treatment of dystonia, spasticity, and other disorders in which muscle overactivity gives rise to symptoms. This review focuses on the pharmacology, electrophysiology, immunology, and application of botulinum toxin in selected neurological disorders.

Animals↗

PubMed2004

Identification of Bacillus anthracis proteins associated with germination and early outgrowth by proteomic profiling of anthrax spores.

The use of anthrax spores as a bioweapon has spurred efforts aimed at identifying key proteins expressed in Bacillus anthracis. Because spore germination and outgrowth occur prior to and are required for disease manifestations, blocking germination and early outgrowth with novel vaccines or inhibitors targeting critical B. anthracis germination and outgrowth-associated factors is a promising strategy in mitigating bioterror. By screening 587 paired protein spots that were isolated from dormant and germinating anthrax spores, respectively, we identified 10 spore proteins with statistically significant germination-associated increases and decreases. It is likely that proteins whose levels change during germination may play key roles in the germination and outgrowth processes, and they should be listed as priority targets for development of prophylactic and therapeutic agents against anthrax. The 31 new proteins identified in this study also complement an emerging proteomic database of B. anthracis.

Bacillus anthracis↗

PubMedDate not supplied

New generation of mucosal adjuvants for the induction of protective immunity.

Invasion of infectious agents through mucosal surfaces can be prevented by use of the common mucosal immune system (CMIS), which interconnects inductive tissues, including Peyer's patches (PPs) and nasopharyngeal-associated lymphoreticular tissue (NALT), and effector tissues of the intestinal and respiratory tracts. In order for the CMIS to induce maximal protective mucosal immunity, co-administration of mucosal adjuvant has been shown to be essential. When vaccine antigen is administered together with mucosal adjuvant, antigen-specific T-helper (Th) 1 and Th2 cells, cytotoxic T lymphocytes (CTLs) and IgA B cell responses are effectively induced by oral or nasal routes via the CMIS. In the early stages of induction of mucosal immune response, the uptake of orally or nasally administered antigens is achieved through a unique set of antigen-sampling cells, M cells located in follicle-associated epithelium (FAE) of inductive sites. After successful uptake, the antigens are immediately processed and presented by the underlying dendritic cells (DCs). Elucidation of the molecular/cellular characteristics of M cells and mucosal DCs will greatly facilitate the design of a new generation of effective mucosal adjuvants and of a vaccine delivery vehicle that maximises the use of the CMIS. Our recent efforts at mucosal vaccine development have focused on nasal administration of vaccine antigen together with nontoxic mutant-based or cytokine-/chemokine-based adjuvant for the induction of the protective immunity. To this end, a chimeric form of a nontoxic adjuvant combining the merits of mutant cholera toxin A subunit (mCT-A) and heat labile toxin B subunit (LT-B) was created as the second generation of detoxified toxin-based mucosal adjuvant. When a vaccine antigen was coexpressed together with an immune stimulatory/delivery molecule in crop seed, this edible vaccine is not only effective but also extremely practical in that it can be produced in huge quantities and preserved and shipped over long distances at room temperature without altering the quality of the vaccine. Because such qualities would greatly facilitate global vaccination, this new generation edible vaccines with a built-in adjuvant and/or M cell-targeted edible vaccine promises to be a powerful weapon for combating infectious diseases and bioterrorism.

Adjuvants, Immunologic↗

PubMedDate not supplied

Mechanisms of action of ribavirin against distinct viruses.

The nucleoside analogue ribavirin has antiviral activity against many distinct viruses both in vitro and in vivo. Five distinct mechanisms have been proposed to explain the antiviral properties of ribavirin. These include both indirect mechanisms (inosine monophosphate dehydrogenase inhibition, immunomodulatory effects) and direct mechanisms (interference with RNA capping, polymerase inhibition, lethal mutagenesis). Recent concerns about bioterrorism have renewed interest in exploring the antiviral activity of ribavirin against unique viruses. In this paper, we review the proposed mechanisms of action with emphasis on recent discoveries, as well as the implications of ribavirin resistance. Evidence exists to support each of the five proposed mechanisms of action, and distinct virus/host combinations may preferentially favour one or more of these mechanisms during antiviral therapy.

Animals↗

PubMedDate not supplied

T-Cell epitope discovery for variola and vaccinia viruses.

Variola major, the causative agent of smallpox, afflicted mankind throughout history until the worldwide World Health Organisation WHO vaccination campaign successfully eradicated the disease. Unfortunately, recent concerns about bioterrorism have renewed scientific interest in this virus. One essential component of our biodefense and preparedness efforts is an understanding of poxvirus immunity. To this end a number of laboratories have sought to discover T- and B-Cell epitopes from select agents such as variola virus. This review focuses on the efforts to identify CD8(+) T-Cell epitopes from poxviruses as a means to develop new vaccines and therapeutics. A wide variety of techniques have been employed by several research groups to provide complementary information regarding cellular immune responses to poxviruses. In the last several years well over 100 T-Cell epitopes have been identified and the work rapidly continues. The information gleaned from these studies will not only give us a greater understanding of immunity to variola virus and other viruses, but also provide a foundation for next generation vaccines and additional tools with which to study host-pathogen interactions.

Amino Acid Sequence↗

PubMed2005

A simulation model for assessing aberration detection methods used in public health surveillance for systems with limited baselines.

Public health officials continue to develop and implement new types of ongoing surveillance systems in an attempt to detect aberrations in surveillance data as early as possible. In public health surveillance, aberrations are traditionally defined as an observed value being greater than an expected historical value for that same time period. To account for seasonality, traditional aberration detection methods use three or more years of baseline data across the same time period to calculate the expected historical value. Due to the recent implementation of short-term bioterrorism surveillance systems, many of the new surveillance systems have limited historical data from which to calculate an expected baseline value. Three limited baseline aberration detection methods, C1-MILD, C2-MEDIUM, and C3-ULTRA, were developed based on a one-sided positive CUSUM (cumulative sum) calculation, a commonly used quality control method used in the manufacturing industry. To evaluate the strengths and weakness of these methods, data were simulated to represent syndromic data collected through the recently developed hospital-based enhanced syndromic surveillance systems. The three methods were applied to the simulated data and estimates of sensitivity, specificity, and false-positive rates for the three methods were obtained. For the six syndromes, sensitivity for the C1-MILD, C2-MEDIUM, and C3-ULTRA models averaged 48.2, 51.3, and 53.7 per cent, respectively. Similarly, the specificities averaged 97.7, 97.8, and 96.1 per cent, respectively. The average false-positive rates for the three models were 31.8, 29.2, and 41.5 per cent, respectively. The results highlight the value and importance of developing and testing new aberration detection methods for public health surveillance data with limited baseline information.

Centers for Disease Control and Prevention, U.S.↗

PubMed2007

Multivariate scan statistics for disease surveillance.

In disease surveillance, there are often many different data sets or data groupings for which we wish to do surveillance. If each data set is analysed separately rather than combined, the statistical power to detect an outbreak that is present in all data sets may suffer due to low numbers in each. On the other hand, if the data sets are added by taking the sum of the counts, then a signal that is primarily present in one data set may be hidden due to random noise in the other data sets. In this paper, we present an extension of the spatial and space-time scan statistic that simultaneously incorporates multiple data sets into a single likelihood function, so that a signal is generated whether it occurs in only one or in multiple data sets. This is done by defining the combined log likelihood as the sum of the individual log likelihoods for those data sets for which the observed case count is more than the expected. We also present another extension, where the concept of combining likelihoods from different data sets is used to adjust for covariates. Using data from the National Bioterrorism Syndromic Surveillance Demonstration Project, we illustrate the new method using physician telephone calls, regular physician visits and urgent care visits by Harvard Pilgrim Health Care members cared for by Harvard Vanguard Medical Associates, a large multi-specialty group practice in Massachusetts. For upper and lower gastrointestinal (GI) illness, there were on average 20 telephone calls, nine urgent care visits and 22 regular physician visits per day. The strongest signal was generated by a single data set and due to a familial outbreak of pinworm disease. The second and third strongest signals were generated by the combined strength of two of the three data sets.

Boston↗

PubMed2006

Mass vaccination: solutions in the skin.

The skin is populated with Langerhans cells, thought to be efficient, potent antigen-presenting cells, that are capable of inducing protective immunity by targeting antigen delivery to the skin. Delivery to the skin may be accomplished by active delivery such as intradermal injection, use of patches or a combination of a universal adjuvant patch with injections. The robust immunity induced by skin targeting can lead to dose sparing, novel vaccines and immune enhancement in populations with poorly responsive immune systems, such as the elderly. Vaccine delivery with patches (transcutaneous immunization), may allow self-administration, ambient temperature stabilization and ease of storage for stockpiling, leading to a new level of efficient vaccine distribution in times of crisis such as a bioterror event or pandemic influenza outbreak. The use of an adjuvant (immunostimulant) patch with injected vaccines has been shown in clinical studies to enhance the immune response to an injected vaccine. This can be used for dose sparing in pandemic influenza vaccines in critically short supply or immune enhancement for poor responders to flu vaccines such as the elderly. Transcutaneous immunization offers a unique safety profile, as adjuvants are sequestered in the skin and only delivered systemically by Langerhans cells. This results in an excellent safety profile and allows use of extremely potent adjuvants. The combination of the skin immune system, safe use of potent adjuvants and ease of delivery suggests that skin delivery of vaccines can address multiple unmet needs for mass vaccination scenarios.

Adjuvants, Immunologic↗

PubMed1999

The evolution of viruses, the emergence of viral diseases: a synthesis that Martinus Beijerinck might enjoy.

The relentless production of viral variants and their selection for improved "fit" are seen from the perspective of the infectious disease sciences as ever-changing viral phenotypes and emerging disease risks. In the Darwinian cause:effect equation, we can characterize very well the effects of mutation and selection--these are catalogued as new viral phenotypes or pathotypes. However, the selective forces themselves driving such changes remain rather mysterious. Many selective forces must be at work, acting on the virus, the host, the host population and the environment. In some instances the virus seems to test new unoccupied niches in the absence of any apparent environmental change, but usually it is clear that changes are driven by human activity. Most important must be the ever increasing density of human, domestic animal and crop plant populations and the consequent increased opportunities for transmission of viral variants. Also important must be the great changes affecting all ecosystems--these especially favor the emergence of new zoonotic viruses and viral "species jumpers." The great increase in human travel and transport carries exotic viruses, vectors and hosts around the world, again favoring viral occupation of new niches. The rise of bioterrorism adds yet another threat. Increasing numbers of emerging viral disease episodes seem to be linked to a decline in global resources for proven public health programs, agricultural extension programs, and the like, programs that have stood in the way of the spread and evolution of viral pathogens. If the relationship between viral evolution and the emergence of new viral diseases is rooted firstly in the host and the host population, then more research and resources must be directed to intervention at these levels rather than at the level of the viruses themselves.

Animals↗

PubMed2003

Development, registration and commercialization of microbial pesticides for plant protection.

Plant protection against pathogens, pests and weeds has been progressively reoriented from a therapeutic approach to a rational use of pesticide chemicals in which consumer health and environmental preservation prevail over any other productive or economic considerations. Microbial pesticides are being introduced in this new scenario of crop protection and currently several beneficial microorganisms are the active ingredients of a new generation of microbial pesticides or the basis for many natural products of microbial origin. The development of a microbial pesticide requires several steps addressed to its isolation in pure culture and screening by means of efficacy bioassays performed in vitro, ex vivo, in vivo, or in pilot trials under real conditions of application (field, greenhouse, post-harvest). For the commercial delivery of a microbial pesticide, the biocontrol agent must be produced at an industrial scale (fermentation), preserved for storage and formulated by means of biocompatible additives to increase survival and to improve the application and stability of the final product. Despite the relative high number of patents for biopesticides, only a few of them have materialized in a register for agricultural use. The excessive specificity in most cases and biosafety or environmental concerns in others are major limiting factors. Non-target effects may be possible in particular cases, such as displacement of beneficial microorganisms, allergenicity, toxinogencity (production of secondary metabolites toxic to plants, animals, or humans), pathogenicity (to plants or animals) by the agent itself or due to contaminants, or horizontal gene transfer of these characteristics to non-target microorganisms. However, these non-target effects should not be evaluated in an absolute manner, but relative to chemical control or the absence of any control of the target disease (for example, toxins derived from the pathogen). Consumer concerns about live microbes due to emerging food-borne diseases and bioterrorism do not help to create a socially receptive environment to microbial pesticides. The future of microbial pesticides is not only in developing new active ingredients based on microorganisms beneficial to plants, but in producing self-protected plants (so-called plant-incorporated pesticides) by transforming agronomically high-value crop plants with genes from biological control agents.

Animals↗

PubMed2005

Rickettsial infections around the world, part 1: pathophysiology and the spotted fever group.

BACKGROUND: The rickettsial diseases are an important group of infectious agents that have dermatological manifestations. These diseases are important to consider in endemic areas, but in certain suspicious cases, possible acts of bioterrorism should warrant prompt notification of the appropriate authorities. OBJECTIVE: In this two part review article, we review these diverse diseases by examining established and up-to-date information about the pathophysiology, epidemiology, clinical manifestations, and treatment of the ricksettsiae. METHODS: Using PubMed to search for relevant articles, we browsed over 500 articles to compose a clinically based review article. RESULTS: Part one focuses on pathophysiology of the rickettsial diseases and the clinical aspects of the spotted fever group. CONCLUSIONS: At the completion of part one of this learning activity, participants should be able to discuss all of the clinical manifestations and treatments of the sported fever group. Participants should also be familiar with the pathophysiology of the rickettsial diseases.

Animals↗

PubMed2004

The enteric toxins of Clostridium perfringens.

The Gram-positive pathogen Clostridium perfringens is a major cause of human and veterinary enteric disease largely because this bacterium can produce several toxins when present inside the gastrointestinal tract. The enteric toxins of C. perfringens share two common features: (1) they are all single polypeptides of modest (approximately 25-35 kDa) size, although lacking in sequence homology, and (2) they generally act by forming pores or channels in plasma membranes of host cells. These enteric toxins include C. perfringens enterotoxin (CPE), which is responsible for the symptoms of a common human food poisoning and acts by forming pores after interacting with intestinal tight junction proteins. Two other C. perfringens enteric toxins, epsilon-toxin (a bioterrorism select agent) and beta-toxin, cause veterinary enterotoxemias when absorbed from the intestines; beta- and epsilon-toxins then apparently act by forming oligomeric pores in intestinal or extra-intestinal target tissues. The action of a newly discovered C. perfringens enteric toxin, beta2 toxin, has not yet been defined but precedent suggests it might also be a pore-former. Experience with other clostridial toxins certainly warrants continued research on these C. perfringens enteric toxins to develop their potential as therapeutic agents and tools for cellular biology.

Amino Acid Sequence↗

PubMed2006

Update and overview of practical epidemiologic aspects of HIV/AIDS among injection drug users in the United States.

In a changing public health landscape in which local, state, and federal agencies must confront threats of bioterrorism, emerging infections, and numerous chronic diseases, transmission of HIV among injection drug users (IDUs) continues to be an important public health issue and one of the driving forces behind the HIV epidemic. Using a computerized MEDLINE search of published articles from January 1981 through October 2005, we conducted a literature review of practical epidemiologic aspects of HIV/AIDS among IDUs in the United States. Although recent trends indicate a decline in the proportion of newly diagnosed HIV infections associated with injection drug use, drug-use behaviors overall still account for 32% of new HIV diagnoses. Factors in addition to syringe sharing contribute to HIV transmission among IDUs: risky sexual behaviors, sharing of drug preparation equipment and drug solutions, and contextual and social factors. Promising approaches for HIV prevention include rapid HIV testing, office-based substance abuse treatment, behavioral interventions, improved communication about syringe exchange programs, and case management. HIV among IDUs continues to be an important public health problem in the 21st century. It is imperative that public health agencies continue to monitor and combat the HIV epidemic among IDUs to ensure that hard-won gains will not be eroded.

Acquired Immunodeficiency Syndrome↗