Characteristics of background check findings in nursing students.

BACKGROUND: Background checks are used in nursing education to assess public risk. To date, no study has described the most common and most serious findings in nursing students. PURPOSE: Our study describes the most common and most serious characteristics of BGC findings in nursing students attending large universities. METHOD: Our retrospective study describes characteristics of aggregated, de-identified background check data from a convenience sample of 16 US nursing programs set in large universities 2014-2019. FINDINGS: Sampled programs collected 45,613 background checks, with 1548 findings (3.4 %). Severity of findings included criminal (62.5 %), non-criminal (4.6 %), felony (0.8 %), and other (11.6 %). Severity data were missing from 20.4 % of records. Finding types included substance use (23.7 %), disorderly conduct (8.7 %), property crimes (2.4 %) and crimes against persons (1 %). Type data was missing from 64.3 % of records. DISCUSSION: Future research should examine whether background check type or severity indicates a nursing student poses a public risk.

Prevalence of Nursing Students With Background Check Findings.

BACKGROUND: Background checks (BGC) have been used in nursing education since the 2000s. Little is known about the prevalence of BGC among nursing students or how these students compare to the general population. METHOD: This retrospective study describes aggregated, de-identified BGC data from 2014-2019 in 16 large nursing programs in the United States. An independent samples t test was used to compare U.S. regional means and Federal Bureau of Investigation (FBI) regional arrest data. RESULTS: The mean percentage of nursing student BGC with findings was 3.2% (minimum .00%, maximum 13.33%, SD 2.98%). The mean prevalence of BGC findings does not significantly differ among U.S. regions. There was no significant difference between BGC results in nursing students and regional FBI arrest data. CONCLUSION: Excluding students with BGC findings has not been studied but may represent a structural barrier to diversification of the nursing profession. Additional research linking BGC findings to public protection is required. [J Nurs Educ. 2024;63(1):32-37.].

Rise and Fall of the Baby Box in the United States.

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Process of Maintaining Self in Individuals Living With Systemic Sclerosis: A Grounded Theory Study of American Women.

BACKGROUND: People with chronic illnesses may struggle to adapt psychologically to the illness experience and have feelings of identity loss, self-diminishment, and biographical disruption. This may limit people's ability to engage in optimal self-management. Systemic sclerosis is a debilitating, stigmatizing, and life-limiting progressive chronic illness with significant disfiguring effects. Little is known about the identity management process in people with disfiguring and debilitating conditions such as systemic sclerosis. PURPOSE: The purpose of this study was to generate a grounded theory explicating the process of maintaining a sense of self in people living with systemic sclerosis. METHODS: Fifteen women with systemic sclerosis were recruited to ensure representation of a range of illness duration and progression. Semi-structured interviews were conducted, transcribed, and analyzed using open, selective, and theoretical coding. RESULTS: A basic social process of "maintaining self" was generated from the data that explained the women's experience of living with systemic sclerosis and how they tried to hold on to their identity. Three core categories were identified. Adapting to changes are the behaviors that participants struggled through to carry on with their everyday lives. Dismantling of self was a distressing internal process where participants lost their sense of self and purpose. Restoring self was a transformative process that allowed participants to rewrite and rebuild their biographies. CONCLUSIONS: Findings suggest that the management of identity was important for understanding how people adapt to life with systemic sclerosis. This study can help nurses better understand how to support patients holistically with the management of systemic sclerosis.

Effects of aluminum-salt, CpG and emulsion adjuvants on the stability and immunogenicity of a virus-like particle displaying the SARS-CoV-2 receptor-binding domain (RBD).

Second-generation COVID-19 vaccines with improved immunogenicity (e.g., breadth, duration) and availability (e.g., lower costs, refrigerator stable) are needed to enhance global coverage. In this work, we formulated a clinical-stage SARS-CoV-2 receptor-binding domain (RBD) virus-like particle (VLP) vaccine candidate (IVX-411) with widely available adjuvants. Specifically, we assessed the in vitro storage stability and in vivo mouse immunogenicity of IVX-411 formulated with aluminum-salt adjuvants (Alhydrogel™, AH and Adjuphos™, AP), without or with the TLR-9 agonist CpG-1018™ (CpG), and compared these profiles to IVX-411 adjuvanted with an oil-in-water nano-emulsion (AddaVax™, AV). Although IVX-411 bound both AH and AP, lower binding strength of antigen to AP was observed by Langmuir binding isotherms. Interestingly, AH- and AP-adsorbed IVX-411 had similar storage stability profiles as measured by antigen-binding assays (competitive ELISAs), but the latter displayed higher pseudovirus neutralizing titers (pNT) in mice, at levels comparable to titers elicited by AV-adjuvanted IVX-411. CpG addition to alum (AP or AH) resulted in a marginal trend of improved pNTs in stressed samples only, yet did not impact the storage stability profiles of IVX-411. In contrast, previous work with AH-formulations of a monomeric RBD antigen showed greatly improved immunogenicity and decreased stability upon CpG addition to alum. At elevated temperatures (25, 37°C), IVX-411 formulated with AH or AP displayed decreased in vitro stability compared to AV-formulated IVX-411and this rank-ordering correlated with in vivo performance (mouse pNT values). This case study highlights the importance of characterizing antigen-adjuvant interactions to develop low cost, aluminum-salt adjuvanted recombinant subunit vaccine candidates.

An mRNA-based platform for the delivery of pathogen-specific IgA into mucosal secretions.

Colonization of the gut and airways by pathogenic bacteria can lead to local tissue destruction and life-threatening systemic infections, especially in immunologically compromised individuals. Here, we describe an mRNA-based platform enabling delivery of pathogen-specific immunoglobulin A (IgA) monoclonal antibodies into mucosal secretions. The platform consists of synthetic mRNA encoding IgA heavy, light, and joining (J) chains, packaged in lipid nanoparticles (LNPs) that express glycosylated, dimeric IgA with functional activity in vitro and in vivo. Importantly, mRNA-derived IgA had a significantly greater serum half-life and a more native glycosylation profile in mice than did a recombinantly produced IgA. Expression of an mRNA encoded Salmonella-specific IgA in mice resulted in intestinal localization and limited Peyer's patch invasion. The same mRNA-LNP technology was used to express a Pseudomonas-specific IgA that protected from a lung challenge. Leveraging the mRNA antibody technology as a means to intercept bacterial pathogens at mucosal surfaces opens up avenues for prophylactic and therapeutic interventions.

Nanoalum Formulations Containing Aluminum Hydroxide and CpG 1018TM Adjuvants: The Effect on Stability and Immunogenicity of a Recombinant SARS-CoV-2 RBD Antigen.

Aluminum-salt vaccine adjuvants (alum) are commercially available as micron-sized particles with varying chemical composition and crystallinity. There are reports of enhanced adjuvanticity when the alum's particle size is reduced to the nanometer range. Previously, we demonstrated that a recombinant receptor-binding domain (RBD)-based COVID-19 vaccine candidate (RBD-J; RBD-L452K-F490W) formulated with aluminum hydroxide (Alhydrogel®; AH) and CpG 1018™ (CpG) adjuvants induced potent neutralizing antibody responses in mice yet displayed instability during storage. In this work, we evaluated whether sonication of AH to the nanometer size range (nanoAH) could further enhance immunogenicity or improve storage stability of the above formulation. The addition of CpG to nanoAH (at mouse doses), however, caused re-agglomeration of nanoAH. AH-CpG interactions were evaluated by Langmuir binding isotherms and zeta potential measurements, and stabilized nanoAH + CpG formulations of RBD-J were then designed by (1) optimizing CpG:Aluminum dose ratios or (2) adding a small-molecule polyanion (phytic acid, PA). Compared with the micron-sized AH + CpG formulation, the two stabilized nanoAH + CpG formulations of RBD-J demonstrated no enhancement in SARS-CoV-2 pseudovirus neutralizing titers in mice, but the PA-containing nanoAH + CpG formulation showed improved RBD-J storage stability trends (at 4, 25, and 37 °C). The formulation protocols presented herein can be employed to evaluate the potential benefits of the nanoAH + CpG adjuvant combination with other vaccine antigens in different animal models.

Perinatal psychiatric practitioner consultation program delivers rapid response to OB/GYN practitioners.

INTRODUCTION: Screening and treatment initiation for perinatal psychiatric conditions is a recommended competency in OB/GYN practitioners, yet perinatal psychiatry is rapidly evolving. Practitioner-to-psychiatrist consultation programs have the potential to improve the management of psychiatric conditions in perinatal women. This study describes utilization of a statewide perinatal psychiatric consultation service by OB/GYN practitioners through examination of the volume, responsivity, content and outcomes of clinical inquiries, and satisfaction. METHODS: This quality improvement study describes the 460 telephone or e-mail consultations requested by OB/GYN practitioners over 2 years and housed within a REDCap database. Data include the characteristics of consult users, month-over-month and total utilization, the patient's perinatal status, the reason for contact, current symptoms and medications, and the consulting psychiatrist recommendations. Practitioner satisfaction with consultation is also described. RESULTS: After completion of triage, the psychiatrist returned the practitioner's call ≤5 min in 59% of consultations. The most common inquiries were for pregnant (64%) women for depressive (51%) or anxiety (46%) symptoms with 47% of inquiries reporting the patient was currently taking a psychiatric medication. Had consultation not been available, referral to mental health (41%) or starting a medication (15%) were most often reported. CONCLUSIONS: This perinatal psychiatric consultation service rapidly and effectively met the needs of practitioners practicing in OB/GYN settings across a state having a critical psychiatry shortage and varying urban and rural geography. Future recommendations include the assessment of direct patient outcomes, practitioner skill attainment, and long-term cost savings of this perinatal psychiatric consultation model.

Serum antibody profiling identifies vaccine-induced correlates of protection against aerosolized ricin toxin in rhesus macaques.

Inhalation of the biothreat agent, ricin toxin (RT), provokes a localized inflammatory response associated with pulmonary congestion, edema, neutrophil infiltration, and severe acute respiratory distress. The extreme toxicity of RT is the result of the toxin's B chain (RTB) promoting rapid uptake into alveolar macrophages and lung epithelial cells, coupled with the A chain's (RTA) potent ribosome-inactivating properties. We previously reported that intramuscular vaccination of rhesus macaques with a lyophilized, alum-adsorbed recombinant RTA subunit vaccine (RiVax®) was sufficient to confer protection against a lethal dose of aerosolized RT. That study implicated RT-specific serum IgG, toxin-neutralizing activity (TNA), and epitope-specific responses as being associated with immunity. However, it was not possible to define actual correlates of protection (COP) because all vaccinated animals survived the RT challenge. We addressed the issue of COP in the current study, by vaccinating groups of rhesus macaques with RiVax® following the previously determined protective regimen (100 µg on study days 0, 30 and 60) or one of two anticipated suboptimal regimens (100 µg on study days 30 and 60; 35 µg on study days 0, 30, and 60). Two unvaccinated animals served as controls. The animals were challenged with ~5 × LD50s of aerosolized RT on study day 110. We report that all vaccinated animals seroconverted prior to RT challenge, with the majority also having measurable TNA, although neither antibody levels nor TNA reached statistical significance with regard to a correlation with protection. By contrast, survival correlated with pre-challenge, epitope-specific serum IgG levels, derived from a competitive sandwich ELISA using a panel of toxin-neutralizing monoclonal antibodies directed against distinct epitopes on RiVax®. The identification of a species-neutral, competitive ELISA that correlates with vaccine-induced protection against RT in nonhuman represents an important advance in the development of medical countermeasures (MCM) against a persistent biothreat.

Antigen-adjuvant interactions, stability, and immunogenicity profiles of a SARS-CoV-2 receptor-binding domain (RBD) antigen formulated with aluminum salt and CpG adjuvants.

Low-cost, refrigerator-stable COVID-19 vaccines will facilitate global access and improve vaccine coverage in low- and middle-income countries. To this end, subunit-based approaches targeting the receptor-binding domain (RBD) of SARS-CoV-2 Spike protein remain attractive. Antibodies against RBD neutralize SARS-CoV-2 by blocking viral attachment to the host cell receptor, ACE2. Here, a yeast-produced recombinant RBD antigen (RBD-L452K-F490W or RBD-J) was formulated with various combinations of aluminum-salt (Alhydrogel®, AH; AdjuPhos®, AP) and CpG 1018 adjuvants. We assessed the effect of antigen-adjuvant interactions on the stability and mouse immunogenicity of various RBD-J preparations. While RBD-J was 50% adsorbed to AH and <15% to AP, addition of CpG resulted in complete AH binding, yet no improvement in AP adsorption. ACE2 competition ELISA analyses of formulated RBD-J stored at varying temperatures (4, 25, 37°C) revealed that RBD-J was destabilized by AH, an effect exacerbated by CpG. DSC studies demonstrated that aluminum-salt and CpG adjuvants decrease the conformational stability of RBD-J and suggest a direct CpG-RBD-J interaction. Although AH+CpG-adjuvanted RBD-J was the least stable in vitro, the formulation was most potent at eliciting SARS-CoV-2 pseudovirus neutralizing antibodies in mice. In contrast, RBD-J formulated with AP+CpG showed minimal antigen-adjuvant interactions, a better stability profile, but suboptimal immune responses. Interestingly, the loss of in vivo potency associated with heat-stressed RBD-J formulated with AH+CpG after one dose was abrogated by a booster. Our findings highlight the importance of elucidating the key interrelationships between antigen-adjuvant interactions, storage stability, and in vivo performance to enable successful formulation development of stable and efficacious subunit vaccines.

Family resiliency and family functioning in Non-Hispanic Black and Non-Hispanic White families of preterm infants.

PURPOSE: The purpose of this study was to examine the relationship between resiliency factors and family functioning in families of preterm infants (< 37 weeks gestation) from two different racial groups hospitalized in a neonatal intensive care unit (NICU). DESIGN AND METHODS: A cross-sectional design was used at five Level III/IV NICUs in a Midwestern city/suburbs. Seventy-nine family units (24 Non-Hispanic Black and 55 Non-Hispanic White) completed four instruments that assessed families' use of specific resiliency factors and a measure of family functioning. Demographic data were also collected. RESULTS: Using linear mixed modeling, the significant predictors of family functioning for both Non-Hispanic Black and Non-Hispanic White, even after adjusting for education, income and race, were the protective factors "hardiness" (coefficient = -0.021) and "resources" (coefficient = -0.0052). The fixed effects in the model accounted for 48% (Marginal R2 = 0.48) of the variance on family functioning and the fixed and random effects accounted for 59% (Conditional R2, 0.59) of the variance on family functioning. Sixteen percent of the total sample rated their family as dysfunctional. CONCLUSIONS: Findings from this study suggest that assessment of protective factors related to hardiness and resources individualize nursing interventions to support the resiliency of both Non-Hispanic Black and Non-Hispanic White families, regardless of differences in income and education. Further research studying resiliency in families of preterm infants is needed to understand the impact on long-term family functioning. PRACTICE IMPLICATIONS: Understandingindividual family strengths,through the identification of resiliency (protective and recovery) factors could predict at-risk families before discharge. In collaboration with other health care professionals, nurses can assess individual family needs and strengths, within the context of their socioeconomic environment, and the racial and cultural influences that are important to the family.

Estimating Vaccine Potency Using Antibody-Based Competition Assays.

The issues of vaccine potency and stability constitute formidable challenges associated with the development and readiness of vaccines for biodefense. In most instances, the vaccines will be stockpiled (at considerable cost) for years and used only in the rare event of a public health emergency. It is therefore imperative that there be means to readily monitor overall stability of the stockpiled vaccines, preferably using reliable in vitro assays, without the need for expensive and labor-intensive animal studies. In this chapter, we describe an in vitro monoclonal antibody-based competition ELISA known as RiCoE for assessing the potency of a ricin toxin subunit vaccine. RiCoE can be applied to drug substance and drug products adsorbed to aluminum salts adjuvant. While RiCoE is specific for ricin toxin, the general methodologies and protocols described herein are amenable to virtually any subunit or even virus-like particle-based vaccine. Ultimately, RiCoE-like assays may replace or at least reduce the need for animal studies in vaccine potency determinations.

Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine.

The development of vaccines against biothreat toxins like ricin (RT) is considered an integral component of the U.S. national security efforts. RiVax is a thermostable, lyophilized RT subunit vaccine adsorbed to aluminum salt adjuvant intended for use by military personnel and first responders. Phase 1 studies indicated that RiVax is safe and immunogenic, while a three-dose intramuscular vaccination regimen in nonhuman primates elicited protection against lethal dose RT challenge by aerosol. Here, we investigated, in a mouse model, the durability of RiVax-induced antibody responses and corresponding immunity to lethal dose RT challenge. Groups of mice were subcutaneously administered 3 or 1 µg of RiVax on days 0 and 21 and challenged with 10× 50% lethal dose (LD50) RT by injection at six different intervals over the course of 12 months. Serum antibody titers and epitope-specific competition assays were determined prior to each challenge. We report that the two-dose, 3-µg regimen conferred near-complete protection against RT challenge on day 35 and complete protection thereafter (challenge days 65, 95, 125, 245, and 365). The two-dose, 3-µg regimen was superior to the 1-µg regimen as revealed by slight differences in survival and morbidity scores (e.g., hypoglycemia, weight loss) on challenge days 35 and 365. In separate experiments, a single 3-µg RiVax vaccination proved only marginally effective at eliciting protective immunity to RT, underscoring the necessity of a prime-boost regimen to achieve full and long-lasting protection against RT. IMPORTANCE Ricin toxin (RT) is a notorious biothreat, as exposure to even trace amounts via injection or inhalation can induce organ failure and death within a matter of hours. In this study, we advance the preclinical testing of a candidate RT vaccine known as RiVax. RiVax is a recombinant nontoxic derivative of RT's enzymatic subunit that has been evaluated for safety in phase I clinical trials and efficacy in a variety of animal models. We demonstrate that two doses of RiVax are sufficient to protect mice from lethal dose RT challenge for up to 1 year. We describe kinetics and other immune parameters of the antibody response to RiVax and discuss how these immune factors may translate to humans.

Recombinant Human Secretory IgA Induces Salmonella Typhimurium Agglutination and Limits Bacterial Invasion into Gut-Associated Lymphoid Tissues.

As the predominant antibody type in mucosal secretions, human colostrum, and breast milk, secretory IgA (SIgA) plays a central role in safeguarding the intestinal epithelium of newborns from invasive enteric pathogens like the Gram-negative bacterium Salmonella enterica serovar Typhimurium (STm). SIgA is a complex molecule, consisting of an assemblage of two or more IgA monomers, joining (J)-chain, and secretory component (SC), whose exact functions in neutralizing pathogens are only beginning to be elucidated. In this study, we produced and characterized a recombinant human SIgA variant of Sal4, a well-characterized monoclonal antibody (mAb) specific for the O5-antigen of STm lipopolysaccharide (LPS). We demonstrate by flow cytometry, light microscopy, and fluorescence microscopy that Sal4 SIgA promotes the formation of large, densely packed bacterial aggregates in vitro. In a mouse model, passive oral administration of Sal4 SIgA was sufficient to entrap STm within the intestinal lumen and reduce bacterial invasion into gut-associated lymphoid tissues by several orders of magnitude. Bacterial aggregates induced by Sal4 SIgA treatment in the intestinal lumen were recalcitrant to immunohistochemical staining, suggesting the bacteria were encased in a protective capsule. Indeed, a crystal violet staining assay demonstrated that STm secretes an extracellular matrix enriched in cellulose following even short exposures to Sal4 SIgA. Collectively, these results demonstrate that recombinant human SIgA recapitulates key biological activities associated with mucosal immunity and raises the prospect of oral passive immunization to combat enteric diseases.

Deciding on Home Birth.

OBJECTIVE: To explore the decision-making processes of women who planned home births and to generate an emerging theoretical description of these processes. DESIGN: Qualitative descriptive study using grounded theory. SETTING: A certified nurse-midwifery home birth practice in a midsized city in the United States. PARTICIPANTS: Eleven adult women who planned home births with certified nurse-midwives. METHODS: We conducted semistructured, in-depth interviews with participants to discuss their decision-making processes regarding planning for their home births. Interviews were recorded and transcribed verbatim. We used open, selective, and theoretical coding and constant comparison to analyze the data. RESULTS: The core category in the decision-making process regarding home birth was Claiming Maternal Space. The three main themes under this core category were Awareness of home birth, Movement from conventional perinatal care, and Shelter Building for labor and birth. CONCLUSION: Our results suggest that women who plan home births greatly value agency during perinatal care. The core category Claiming Maternal Space represented how participants solved the problem of decreased agency in conventional perinatal care. Further research is needed to validate the emerging theoretical description and explore the association between agency and perinatal outcomes.

Differences in Utilization of Perinatal Psychiatric Teleconsultation Line Between Primary Care and Mental Health Providers.

PURPOSE: Teleconsultation has been a newly recognized avenue by which to provide psychiatric services to perinatal populations being treated either by psychiatric or primary care providers. The Periscope Project (TPP) is a business-hours teleconsultation line providing enrolled clinicians with access to a subspecialty-trained psychiatrist, as well as community resources and provider education. This study examines the differences in consultation between enrolled providers. METHODS: Encounter data was entered into REDCap by TPP's team members. Data was analyzed using summary statistics. Satisfaction information was attained by follow-up survey. RESULTS: During the first 24 months of program activity, TPP had a total of 737 referred encounters, 70.4% from primary care and 20.5% from psychiatry. There were statistically significant differences between psychiatric and primary care providers in terms of recommendations for use of certain types of medications and use of diagnostic screenings, as well as differences in what providers would have recommended in absence of TPP's involvement. CONCLUSIONS: Differences in enrollee's rationale for consultation allows for better understanding of the needs of front-line providers. Tailoring educational information and even teleconsultation information based on provider group can allow for more efficient patient care and resource utilization. Providers across the spectrum found TPP beneficial, indicating that continued availability to all providers caring for women of reproductive age is important.

Maternity Nurses' Responses to Maternal Early Warning Criteria.

OBJECTIVE: The purpose of this study was to assess the influence of nursing care on implementing perinatal risk-appropriate care in the context of maternal early warning criteria. DESIGN: Medical record review and survey of maternity nurses in a three-hospital system in Wisconsin with two level I hospitals and 1 level III hospital. PARTICIPANTS: Seven maternity nurses from the level III hospital conducted the medical record reviews and all maternity staff nurses from two level I hospitals were invited to complete the survey. MEASUREMENTS: All medical records in 2017 that met these inclusion criteria: hypertension, sepsis, preeclampsia, hemorrhage, low Apgar scores, and transport were reviewed to assess identification and response time for maternal early warning signs using the Nurses Contribution to Maternal Mortality Worksheet. The survey included questions about influences on the nurses' confidence when interpreting early warning indicators. RESULTS: Thirty-two medical records met inclusion criteria and were reviewed. The number of maternal early warning signs recorded ranged from one to four, with a mean of 1.75 indicators. Eighty percent of records documented increased evaluation as a nursing response to the maternal early warning signs. Time-lapse between notifying a provider and bedside evaluation was less than 15 minutes in 54% of cases. Of the 31 eligible nurses, 18 completed the survey (58% response rate). Personal knowledge (90%) was reported by nurses as being the greatest influence on nursing confidence. Sixty-nine percent of nurses reported not receiving patient information from team members at the transporting hospital. CONCLUSION: A systematic record review by frontline nurses can monitor identification and response to maternal early warning signs. Feedback on patient transports can reinforce nurses' decision-making that has the potential to improve responsiveness to clinical warning signs.

How do genes flow? Identifying potential dispersal mode for the semi-aquatic lichen Dermatocarpon luridum using spatial modelling and photobiont markers.

BACKGROUND: Landscape genetics is an interdisciplinary field that combines tools and techniques from population genetics with the spatially explicit principles from landscape ecology. Spatial variation in genotypes is used to test hypotheses about how landscape pattern affects dispersal in a wide range of taxa. Lichens, symbiotic associations between mycobionts and photobionts, are an entity for which little is known about their dispersal mechanism. Our objective was to infer the dispersal mechanism in the semi-aquatic lichen Dermatocarpon luridum using spatial models and the spatial variation of the photobiont, Diplosphaera chodatii. We sequenced the ITS rDNA and the ß-actin gene regions of the photobiont and mapped the haplotype spatial distribution in Payuk Lake. We subdivided Payuk Lake into subpopulations and applied four spatial models based on the topography and hydrology to infer the dispersal mechanism. RESULTS: Genetic variation corresponded with the topography of the lake and the net flow of water through the waterbody. A lack of isolation-by-distance suggests high gene flow or dispersal within the lake. We infer the dispersal mechanism in D. luridum could either be by wind and/or water based on the haplotype spatial distribution of its photobiont using the ITS rDNA and ß-actin markers. CONCLUSIONS: We inferred that the dispersal mechanism could be either wind and/or water dispersed due to the conflicting interpretations of our landscape hypotheses. This is the first study to use spatial modelling to infer dispersal in semi-aquatic lichens. The results of this study may help to understand lichen dispersal within aquatic landscapes, which can have implications in the conservation of rare or threatened lichens.

Endpoint and epitope-specific antibody responses as correlates of vaccine-mediated protection of mice against ricin toxin.

The successful licensure of vaccines for biodefense is contingent upon the availability of well-established correlates of protection (CoP) in at least two animal species that can be applied to humans, without the need to assess efficacy in the clinic. In this report we describe a multivariate model that combines pre-challenge serum antibody endpoint titers (EPT) and values derived from an epitope profiling immune-competition capture (EPICC) assay as a predictor in mice of vaccine-mediated immunity against ricin toxin (RT), a Category B biothreat. EPICC is a modified competition ELISA in which serum samples from vaccinated mice were assessed for their ability to inhibit the capture of soluble, biotinylated (b)-RT by a panel of immobilized monoclonal antibodies (mAbs) directed against four immunodominant toxin-neutralizing regions on the enzymatic A chain (RTA) of RT. In a test cohort of mice (n = 40) vaccinated with suboptimal doses of the RTA subunit vaccine, RiVax®, we identified two mAbs, PB10 and SyH7, which had EPICC inhibition values in pre-challenge serum samples that correlated with survival following a challenge with 5 × LD50 of RT administered by intraperitoneal (IP) injection. Analysis of a larger cohort of mice (n = 645) revealed that a multivariate model combining endpoint titers and EPICC values for PB10 and SyH7 as predictive variables had significantly higher statistical power than any one of the independent variables alone. Establishing the correlates of vaccine-mediated protection in mice represents an important steppingstone in the development of RiVax® as a medical countermeasure under the United States Food and Drug Administration's "Animal Rule."