Studies with herpes zoster vaccines in immune compromised patients.

INTRODUCTION: The active component of the herpes zoster vaccine (ZVL), licensed for people ≥50 years of age, is a live attenuated varicella-zoster virus. ZVL is contraindicated for immune compromised individuals, with limited regard to the degree of immunosuppression. Areas covered: This review evaluates phase I and II and observational studies for ZVL, and published reports of the off-label use of ZVL, for conditions and therapies for which investigators considered the risk-benefit for using ZVL to be favorable. It also discusses exploratory trials of ZVL for additional immune compromising conditions, and summarizes clinical guidelines from many countries and professional societies that are based upon recent investigations. Studies in immune compromised patients of investigational vaccines that do not contain live virus are reviewed. Expert commentary: It is likely that past and ongoing research with ZVL will define immune compromising diseases and/or therapies for which the risk-benefit for using ZVL vaccine is favorable. The main variables to consider in this assessment in immune compromised patients are safety, immunogenicity, protection against herpes zoster, and persistence of protection. Vaccination against herpes zoster prior to suppressing immunity is an important clinical strategy, although efficacy of this approach has not been evaluated in a clinical trial.

Communicating information in an emergency preparedness pill distribution campaign.

OBJECTIVES: Public health agencies are often tasked with the development and execution of interventions, but the communication strategy and its impact on the effectiveness of an intervention is often not evaluated or incorporated by local and state health agencies. The primary objective of this study was to determine the impact of information from various sources on knowledge about an emergency preparedness public health intervention involving the mass distribution of medicine. METHODS: The study used validated written mail surveys containing 12 simple knowledge-based questions. One-way ANOVA, the Studentized Newman-Keuls (SNK) test, logistic regression, and multiple regression were used to evaluate the data. RESULTS: Reading an educational fact sheet or receiving job training were the highest predictive variables for correct responses on the survey among all groups. Commercial media were found to potentially diminish comprehension among survey respondents. There was significant variability in knowledge among different groups surveyed, ranging from an average of 15% to 74% correct responses on the survey. CONCLUSIONS: This study found that job training and fact sheets that are delivered directly to the intended recipients are very effective at enhancing knowledge among the general public and emergency responders. Conversely, we found that commercial media, such as television, may be detrimental to educating the public about important public health interventions. The internet was not widely used by the survey respondents to obtain information; this raises questions regarding the usefulness of websites for emergency preparedness education.

A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy.

BACKGROUND: In contrast to pharmaceutical manufacturers, compounding pharmacies adhere to different quality-control standards, which may increase the likelihood of undetected outbreaks. In 2005, the Centers for Disease Control and Prevention received reports of cases of Serratia marcescens bloodstream infection occurring in patients who underwent cardiac surgical procedures in Los Angeles, California, and in New Jersey. An investigation was initiated to determine whether there was a common underlying cause. METHODS: A matched case-control study was conducted in Los Angeles. Case record review and environmental testing were conducted in New Jersey. The Centers for Disease Control and Prevention performed a multistate case-finding investigation; isolates were compared using pulsed-field gel electrophoresis analysis. RESULTS: Nationally distributed magnesium sulfate solution (MgSO(4)) from compounding pharmacy X was the only significant risk factor for S. marcescens bloodstream infection (odds ratio, 6.4; 95% confidence interval, 1.1-38.3) among 6 Los Angeles case patients and 18 control subjects. Five New Jersey case patients received MgSO(4) from a single lot produced by compounding pharmacy X; culture of samples from open and unopened 50-mL bags in this lot yielded S. marcescens. Seven additional case patients from 3 different states were identified. Isolates from all 18 case patients and from samples of MgSO(4) demonstrated indistinguishable pulsed-field gel electrophoresis patterns. Compounding pharmacy X voluntarily recalled the product. Neither the pharmacy nor the US Food and Drug Administration could identify a source of contamination in their investigations of compounding pharmacy X. CONCLUSIONS: A multistate outbreak of S. marcescens bloodstream infection was linked to contaminated MgSO(4) distributed nationally by a compounding pharmacy. Health care personnel should take into account the different quality standards and regulation of compounded parenteral medications distributed in large quantities during investigations of outbreaks of bloodstream infection.

Survey of current lead use, handling, hygiene, and contaminant controls among New Jersey industries.

In 2003, a chemical handling and use survey was mailed to New Jersey employers identified as currently using lead in their industrial processes. This survey was used to ascertain characteristics about lead use, handling, and protection of employees during manufacturing operations. The survey included a diverse group of current lead users with a total lead use range from less than 1 pound to more than 63 million pounds of lead per year. The survey allowed for a comprehensive characterization of hazards and protective measures associated with this metal, still commonly used in many products and industrial processes. Forty-five surveys were returned by companies that are listed in the New Jersey Adult Blood Lead Registry, which is part of the New Jersey Adult Blood Lead Epidemiology and Surveillance (ABLES) program. This program records and investigates cases of adults with greater than 25 mu g/dL of lead in their blood; most cases are related to occupational exposures. This survey found that greater than 25% of these surveyed companies with significant potential for lead exposure did not employ commonly used and basic industrial hygiene practices. In addition, the survey found that 24% of these companies had not conducted air sampling within the last 3 years. Air sampling is the primary trigger for compliance with the Occupational Safety and Health Administration (OSHA) general industry lead standard. Only 17% of the companies have ever been cited for a violation of the OSHA lead standard, and only 46% of these companies have ever had an OSHA inspection. State-based surveillance can be a useful tool for OSHA enforcement activities. Elevated blood lead values in adults should be considered as a trigger for required compliance with an OSHA general industry lead standard.

Clostridium difficile-associated disease in New Jersey hospitals, 2000-2004.

Recent emergence of a virulent strain of Clostridium difficile demonstrates the importance of tracking C. difficile incidence locally. Our survey of New Jersey hospitals documented increases in the rates of C. difficile disease (by 2-fold), C. difficile-associated complications (by 7-fold), and C. difficile outbreaks (by 12-fold) during 2000-2004.

Survey of state practices during the 2004-2005 influenza vaccine shortage.

To describe state-level actions and policies during the 2004-2005 influenza vaccine shortage and determine whether these or other factors were related to vaccination coverage, we surveyed all state health departments (including the District of Columbia). We included 2004-2005 Behavioral Risk Factor Surveillance System data to examine whether state-level actions, policies, or other factors like vaccine supply were related to changes in vaccination coverage in adults aged > or = 65 years from the previous non-shortage year. We found that 96% (n = 49) of states reported adopting or recommending adherence to the initial national interim influenza vaccination recommendations. Of these, at some point during the season, 22% (n = 11) reported local public health agencies issued prioritization recommendations that differed from the state health department's guidance. Eighty percent (n = 41) initiated at least one emergency response activity and 43% (n = 22) referred to or implemented components of their pandemic influenza plans. In 35% (n = 18), emergency or executive orders were issued or legislative action occurred. In a multivariable linear regression model, the availability and use of practitioner contact lists and having a relatively high vaccine supply in early October 2004 were associated with smaller decreases in coverage for adults aged > or = 65 years from the previous non-shortage season (p = 0.003, r2 = 0.26). States over-whelmingly followed national vaccination prioritization guidelines and used a range of activities to manage the 2004-2005 vaccine shortage. The availability and use of practitioner contact lists and having a relatively high vaccine supply early in the season were associated with smaller decreases in coverage from the previous non-shortage season.

Evaluation of potassium iodide prophylaxis knowledge and nuclear emergency preparedness: New Jersey 2005.

The Nuclear Regulatory Commission requires states to consider including potassium iodide as a protective measure in the unlikely event of a major release of radioactivity from a nuclear power plant. We evaluated emergency preparedness knowledge, including proper potassium iodide use, among the general public and emergency responders located around New Jersey's nuclear power plants. We found that knowledge about responder chain of command, evacuation routes, and some aspects of potassium iodide usage was incomplete among the general public and emergency responders.

Assessment of potassium iodide (KI) distribution program among communities within the emergency planning zones (EPZ) of two nuclear power plants.

The primary objective of this study was to evaluate a joint state and local government-sponsored potassium iodide (KI) distribution program in New Jersey. This program is part of a radiological emergency response system for residents living within the Emergency Planning Zones (EPZs) of nuclear power facilities. KI pills and an informational fact sheet were distributed locally at six different public clinics in the summer of 2002. In this study, a mailed survey was developed, pilot tested, and sent to the general public to assess knowledge about KI use. The survey consisted of two groups of people, those who attended a KI distribution clinic and those that did not attend a clinic. There was a statistically significant difference in knowledge among the two groups of survey respondents regarding KI prophylaxis, with a mean of 46% of survey questions answered correctly by those who attended a clinic vs. 15% by those who did not attend. Certain questions were problematic for the public to answer correctly and included potential low compliance with government instructions for taking KI, confusion regarding where the public can obtain KI pills during an emergency, and the lack of awareness on the proper use of KI for children, pregnant women, and persons over the age of 40 y. Additional outreach in these specific areas is warranted. This study also found that there was a highly variable geographic pattern of homes that have a supply of KI pills, with some areas having 60% of the households supplied with pills from the clinic while other areas had as low as 1% of the homes supplied with KI pills.

Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation.

CONTEXT: Botulism is a potentially lethal paralytic disease caused primarily by toxins of the anaerobic, spore-forming bacterium Clostridium botulinum. Although botulinum toxin A is available by prescription for cosmetic and therapeutic use, no cases of botulism with detectable serum toxin have previously been attributed to cosmetic or therapeutic botulinum toxin injections. On November 27, 2004, 4 suspected botulism case-patients with a link to cosmetic botulinum toxin injections were reported to the Centers for Disease Control and Prevention. OBJECTIVE: To investigate the clinical, epidemiological, and laboratory aspects of 4 suspected cases of iatrogenic botulism. DESIGN, SETTING, AND PATIENTS: Case series on 4 botulism case-patients. MAIN OUTCOME MEASURES: Clinical characteristics of the 4 case-patients, epidemiological associations, and mouse bioassay neutralization test results from case-patient specimens and a toxin sample. RESULTS: Clinical characteristics of the 4 case-patients were consistent with those of naturally occurring botulism. All case-patients had been injected with a highly concentrated, unlicensed preparation of botulinum toxin A and may have received doses 2857 times the estimated human lethal dose by injection. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21 to 43 times the estimated human lethal dose; pretreatment serum from the fourth epidemiologically linked case-patient was not available. A 100-microg vial of toxin taken from the same manufacturer's lot as toxin administered to the case-patients contained a toxin amount sufficient to kill approximately 14,286 adults by injection if disseminated evenly. CONCLUSIONS: These laboratory-confirmed cases of botulism demonstrate that clinical use of unlicensed botulinum toxin A can result in severe, life-threatening illness. Further education and regulation are needed to prevent the inappropriate marketing, sale, and clinical use of unlicensed botulinum toxin products.

Pulmonary and psychosocial findings at enrollment in the ACCESS study.

AIM: To assess lung involvement and the association of demographic and psychosocial factors with respiratory health in 736 persons with sarcoidosis at enrollment in A Case Control Etiologic Study of Sarcoidosis (ACCESS). METHODS: 736 patients with biopsy diagnosis of sarcoidosis within 6 months of enrollment were studied at 10 US centers. Lung involvement was evaluated by chest radiography, spirometry and dyspnea questionnaire. Demographics, number of involved extrathoracic organ systems, comorbidities, and health-related quality of life (HRQL) were assessed. RESULTS: 95% of patients had lung involvement. 8% were Scadding Stage 0, 40% I, 37% II, 10% III, and 5% IV 51% reported dyspnea. Increasing radiographic lung stage was associated with decreasing Forced Vital Capacity (FVC) (p < 0.01). Patients with higher stages had more airways obstruction and dyspnea. 46% of cases and 27% of controls had Center for Epidemiologic Studies Depression Scale (CES-D) scores of 9 or greater, (p < 0.001). Age > or = 40, African-American race, body mass index > or = 30kg/m2, and CES-D scores > 9 were associated with decreased FVC and greater dyspnea. Impaired spirometry and greater dyspnea were associated with poorer quality of life. CONCLUSION: A "global" approach to the sarcoidosis patient, including careful assessment of dyspnea and health related quality of life, as well as of lung function and radiographic changes, and any extrathoracic involvement, is important, not only in management of the individual patient, but should also prove beneficial in assessing outcomes in clinical trials in the future.

Relationship of environmental exposures to the clinical phenotype of sarcoidosis.

STUDY OBJECTIVES: Sarcoidosis is a granulomatous disorder with heterogeneous clinical manifestations, which are potentially reflective of a syndrome with different etiologies leading to similar histologic findings. We examined the relationship between environmental and occupational exposures, and the clinical phenotype of sarcoidosis. DESIGN: We performed a cross-sectional study of incident sarcoidosis cases that had been identified by A Case Control Etiologic Study of Sarcoidosis. Subjects were categorized into the following two groups: (1) pulmonary-only disease; and (2) systemic disease (with or without pulmonary involvement). Logistic regression was used to examine the associations of candidate exposures with clinical phenotype. SETTING: Ten academic medical centers across the United States. PATIENTS: The current study included 718 subjects in whom sarcoidosis had been diagnosed within 6 months of study enrollment. Patients met the following criteria prior to enrollment: (1) tissue confirmation of noncaseating granulomas on tissue biopsy on one or more organs within 6 months of study enrollment with negative stains for acid-fast bacilli and fungus; (2) clinical signs or symptoms that were consistent with sarcoidosis; (3) no other obvious explanation for the granulomatous disease; and (4) age > 18 years. MEASUREMENTS AND RESULTS: Several exposures were associated with significantly less likelihood of having extrapulmonary disease in multivariate analysis, including agricultural organic dusts and wood burning. The effects of many of these exposures were significantly different in patients of different self-defined race. CONCLUSIONS: The differentiation of sarcoidosis subjects on the basis of clinical phenotypes suggests that these subgroups may have unique environmental exposure associations. Self-defined race may play a role in the determination of the effect of certain exposures on disease phenotypes.

New Jersey's smallpox vaccination clinic experiences, 2003.

PURPOSE: During 2003, the New Jersey Department of Health and Senior Services, in collaboration with other agencies, began planning and implementing voluntary smallpox vaccination clinics. METHODS: Surveys were distributed to all vaccinees, hospital bioterrorism coordinators, and local health departments to assess clinic experiences. RESULTS: During January-July 2003, 23 clinics were conducted with more than 1,000 participants. Of 670 persons vaccinated, 529 (79%) completed surveys. We received 65 surveys from 68 (77%) of 84 hospitals, and 25 responses from 22 regional health agencies. CONCLUSIONS: Vaccination is one component of preparedness; future initiatives must incorporate multiagency collaboration and developing public health infrastructure.

Job and industry classifications associated with sarcoidosis in A Case-Control Etiologic Study of Sarcoidosis (ACCESS).

OBJECTIVES: To determine whether specific occupations and industries may be associated with sarcoidosis. METHODS: A Case Control Etiologic Study of Sarcoidosis (ACCESS) obtained occupational and environmental histories on 706 newly diagnosed sarcoidosis cases and matched controls. We used Standard Industrial Classification (SIC) and Standard Occupational Classification (SOC) to assess occupational contributions to sarcoidosis risk. RESULTS: Univariable analysis identified elevated risk of sarcoidosis for workers with industrial organic dust exposures, especially in Caucasian workers. Workers for suppliers of building materials, hardware, and gardening materials were at an increased risk of sarcoidosis as were educators. Work providing childcare was negatively associated with sarcoidosis risk. Jobs with metal dust or metal fume exposures were negatively associated with sarcoidosis risk, especially in Caucasian workers. CONCLUSIONS: In this study, we found that exposures in particular occupational settings may contribute to sarcoidosis risk.

Hospital recruitment for the Smallpox Pre-Event Vaccination Program: experiences from Florida, Nebraska, New Jersey, and Tennessee, December 2002-June 2003.

The Smallpox Pre-Event Vaccination Program (SPVP) for public health and hospital-based health care workers began on January 24, 2003. This report summarizes efforts made by health officials in Florida, Nebraska, New Jersey, and Tennessee to facilitate the voluntary participation of acute care hospitals in the SPVP. Seven common characteristics contributed to the success of programs in these four states: (1) early planning, building on existing competencies, and state government support, (2) carrying the program forward on a planned timeline with experienced vaccination staff, (3) use of multifaceted training activities, (4) use of mock scenarios and field exercises to avoid early problems, (5) establishment and fostering of good relationships and lines of communication with stakeholders and the mass media, (6) addressing liability and workers' compensation concerns prior to initiation of the SPVP, and (7) attention to vaccination clinic logistics.