SUMMARYIn November 2009, we initiated a multistate investigation of Salmonella Montevideo infections with pulsed-field gel electrophoresis pattern JIXX01.0011. We identified 272 cases in 44 states with illness onset dates ranging from 1 July 2009 to 14 April 2010. To help generate hypotheses, warehouse store membership card information was collected to identify products consumed by cases. These records identified 19 ill persons who purchased company A salami products before onset of illness. A case-control study was conducted. Ready-to-eat salami consumption was significantly associated with illness (matched odds ratio 8·5, 95% confidence interval 2·1–75·9). The outbreak strain was isolated from company A salami products from an environmental sample from one manufacturing plant, and sealed containers of black and red pepper at the facility. This outbreak illustrates the importance of using membership card information to assist in identifying suspect vehicles, the potential for spices to contaminate ready-to-eat products, and preventing raw ingredient contamination of these products.
T o date, there has not been a systematic evaluation of the relationship between anthrax vaccine-stimulated humoral and cell-mediated immune responses, their relative contributions to protection, or their comparative importance when used singly or in combination to predict the probability of survival in animal models or in humans.Anthrax toxin protective antigen (PA) is the primary immunogen in licensed anthrax vaccines in the United States and the European Union, as well as in many of the second-generation anthrax vaccines in current development (1). Consequently, the quantitative analysis of anti-PA IgG antibody levels and lethal toxin neutralization activity (TNA) in serum are generally accepted as immunological correlates of protection (COP) for vaccine efficacy in animal models (2). Anti-PA IgG levels and TNA are also considered pivotal for cross-species predictions of anthrax vaccine efficacy in humans, for whom clinical efficacy studies are either impractical or ethically infeasible (3, 4) (http://www.fda .gov/AdvisoryCommittees/CommitteesMeetingMaterials/Blood VaccinesandOtherBiologics/VaccinesandRelatedBiologicalProducts AdvisoryCommittee/ucm239733.htm). Anti-PA IgG and TNA levels, however, are but one part of the spectrum of humoral and cell-mediated immune responses that may contribute to protection. The COP for anthrax may differ depending on vaccine formulations, schedules, and routes of administration (5-10).The U.S.-licensed anthrax vaccine adsorbed (AVA) (BioThrax) was approved in 1970 for the prevention of anthrax in humans (11)(12)(13)(14). The original regimen for AVA was a subcutaneous (s.c.) six-dose primary schedule at 0, 0.5, 1, 6, 12, and 18 months, with subsequent annual boosters. In May 2012, the U.S. Food and Drug Administration (FDA) approved the AVA regimen as an intramuscular (i.m.) three-dose priming schedule at 0, 1, and 6 months, with boosters at 12 and 18 months and annually thereafter (http://www .fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts /ucm304758.htm). These recent changes in the schedule and administration route were based on data from the Centers for Disease Control and Prevention Anthrax Vaccine Research Program (AVRP) (12, 13). The goals of the AVRP were to improve the AVA safety profile and ensure efficacy while minimizing the number of doses required. The study objectives included determining immunological correlates of protection, documenting vaccine efficacy, and optimizing the vaccination schedule and route of administration (14). Due to the low prevalence of inhalation anthrax and the ethical concerns of conducting an efficacy trial in humans, vaccine efficacy and duration of protection were evaluated in rhesus macaques (Macaca mulatta) (15).The AVRP nonhuman primate (NHP) study used the 0-, 1-, and 6-month intramuscular priming series (3-i.m.) with a full human dose or saline dilutions of AVA to modulate the immune response. The NHP were challenged with high-dose (median, 504ϫ the 50% lethal dose [LD 50 ]) aerosolized Bacillus anthracis spores at m...
This is the first reported Salmonella outbreak in the United States linked to fresh, whole papayas. The outbreak highlights important issues regarding the safety of imported produce.
Anthrax Vaccine Adsorbed (AVA, BioThrax) is approved for use in humans as a priming series of 3 intramuscular (i.m.) injections (0, 1, 6 months; 3-IM) with boosters at 12 and 18 months, and annually thereafter for those at continued risk of infection. A reduction in AVA booster frequency would lessen the burden of vaccination, reduce the cumulative frequency of vaccine associated adverse events and potentially expand vaccine coverage by requiring fewer doses per schedule. Because human inhalation anthrax studies are neither feasible nor ethical, AVA efficacy estimates are determined using cross-species bridging of immune correlates of protection (COP) identified in animal models. We have previously reported that the AVA 3-IM priming series provided high levels of protection in non-human primates (NHP) against inhalation anthrax for up to 4 years after the first vaccination. Penalized logistic regressions of those NHP immunological data identified that anti-protective antigen (anti-PA) IgG concentration measured just prior to infectious challenge was the most accurate single COP. In the present analysis, cross-species logistic regression models of this COP were used to predict probability of survival during a 43 month study in humans receiving the current 3-dose priming and 4 boosters (12, 18, 30 and 42 months; 7-IM) and reduced schedules with boosters at months 18 and 42 only (5-IM), or at month 42 only (4-IM). All models predicted high survival probabilities for the reduced schedules from 7 to 43 months. The predicted survival probabilities for the reduced schedules were 86.8% (4-IM) and 95.8% (5-IM) at month 42 when antibody levels were lowest. The data indicated that 4-IM and 5-IM are both viable alternatives to the current AVA pre-exposure prophylaxis schedule.
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