Social cognition and African American men: The roles of perceived discrimination and experimenter race on task performance.

The Social Cognition Psychometric Evaluation (SCOPE) study consists of a battery of eight tasks selected to measure social-cognitive deficits in individuals with schizophrenia. The battery is currently in a multisite validation process. While the SCOPE study collects basic demographic data, more nuanced race-related factors might artificially inflate cross-cultural differences in social cognition. As an initial step, we investigated whether race, independent of mental illness status, affects performance on the SCOPE battery. Thus, we examined the effects of perceived discrimination and experimenter race on the performance of 51 non-clinical African American men on the SCOPE battery. Results revealed that these factors impacted social cognitive task performance. Specifically, participants performed better on a skills-based task factor in the presence of Black experimenters, and frequency of perceived racism predicted increased perception of hostility in negative interpersonal situations with accidental causes. Thus, race-related factors are important to identify and explore in the measurement of social cognition in African Americans.

Evaluation of a non-invasive, inhalational challenge method for rabies vaccine potency assay.

Veterinary rabies vaccines are essential for safeguarding the public from exposure to rabies virus, as vaccination of domestic animals provides a barrier between humans and wildlife reservoirs. Ensuring rabies vaccines are potent and effective is paramount in preventing human exposure to rabies virus. The National Institutes of Health (NIH) test, a mouse vaccination-challenge assay, is the most widely used and internationally recognized assay for potency testing of inactivated rabies vaccines, and it is currently considered the method of choice. In the NIH test, vaccinated mice are challenged by the intracranial (IC) route. The response to the IC challenge can be variable, which often results in invalid tests. In addition, the IC challenge-exposure raises animal welfare concerns. The objective of this study was to evaluate the intranasal route of challenge as a modification to the NIH test to reduce animal pain and suffering until harmonized requirements for in vitro testing of rabies vaccines are developed. Results confirm the intranasal route is an effective route of rabies challenge in mice. However, a valid challenge requires the use of a more concentrated inoculum, in comparison to the intracranial method.

Rabies vaccine standards: comparison of the 5th and 6th WHO international reference standards to the USDA veterinary reference standard.

Ensuring rabies vaccines are potent and effective is paramount in preventing transmission of this deadly disease and safeguarding public health. Efficacy of human and veterinary vaccines is ensured by evaluating relative potency estimates of the vaccine compared to a rabies reference standard using the National Institutes of Health (NIH) test. Reference vaccines are based on the International Standard for Rabies Vaccine provided by the World Health Organization (WHO). A comparison study was conducted to determine the relative potency of the 5th WHO, 6th WHO, and United States Department of Agriculture's (USDA) 08-14 reference standards using the NIH test. Results from the study demonstrate that the 6th WHO reference standard is approximately twice as potent as the 5th WHO reference when reconstituted to contain 1 IU per ml. Based on these results, the Center for Veterinary Biologics (CVB) doubled the reconstitution volume of USDA veterinary reference 08-14 from 13 ml to 26 ml, for an initial use dilution of 0.7 IU per ml for use by veterinary biologics manufacturers in the NIH test. This study emphasizes the importance of reference standard calibration for use in the National Institutes of Health test.

Potency testing of veterinary rabies vaccines: replacement of challenge by in vitro testing: considerations for development of alternative assays.

Vaccination of domestic animals against rabies creates a critical barrier between wildlife reservoirs and the human population. Ensuring these vaccines are potent and effective is paramount in preventing human exposure to this deadly and costly disease. The National Institutes of Health (NIH) test is, at present, the most widely used and internationally recommended potency assay for batch testing inactivated rabies vaccines. This test has numerous inherent limitations and disadvantages, including a lack of precision. The NIH test requires a large number of animals and involves unrelieved pain and suffering. A relevant in vitro assay should provide a more accurate, reproducible, rapid, safe, and humane rabies vaccine potency test.

Evaluation of the analytical sensitivity of a polymerase chain reaction assay for the detection of chicken infectious anemia virus in avian vaccines.

Chicken infectious anemia virus (CAV) is a ubiquitous pathogen of chickens causing significant disease in commercial flocks worldwide. During CAV outbreaks, the Center for Veterinary Biologics requires manufacturers of veterinary biologicals to test materials derived from infected flocks for extraneous CAV by polymerase chain reaction (PCR). The analytical sensitivity of a PCR assay for detection of CAV was determined and the applicability of a CAV DNA standard as a positive control for assay validity was evaluated. The analytical sensitivity of the CAV PCR assay was assessed to be 100 copies per reaction for the DNA standard and 1 × 10¹·9 TCID50/reaction for infectious virus. Establishing the analytical sensitivity of this CAV PCR assay and the inclusion of internal and external positive controls for validity provide a basis for determining whether suspect materials are safe for use in the production of veterinary biologics.

Regulatory considerations for emergency use of non-USDA licensed vaccines in the United States.

The Virus-Serum-Toxin Act of 1913 (21 US Code 151-159) provides the legal basis for the regulation of veterinary biologicals in the United States; the United States Department of Agriculture's Center for Veterinary Biologicals (CVB) has the regulatory authority for the issue of licences and permits for such products. The law was intended to establish standards and control the importation of products into the United States and the distribution of products interstate assuring the purity, safety, potency, and efficacy of veterinary biological products. Administrative regulations and standards appear in the Title 9, Code of Federal Regulations, Parts 101-118, with additional programme guidance found in CVB Notices, Veterinary Services Memoranda, General Licensing Considerations, and other guidance documents. Pre-licensing data evaluation procedures are designed to assess the purity, safety, potency, and effectiveness of each product and support all product label claims. To fulfil these criteria, data from all phases of product development are evaluated against these key elements. Under the standard licensing process, this spectrum of evaluation includes complete characterization and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This comprehensive evaluation may not be possible during the emergence of a new animal disease. While there are no specific regulations addressing the licensing standards of products for an emerging animal disease, there are mechanisms that allow for the availability of products in an emergency animal health situation. These mechanisms include autogenous biologicals, conditional licences, experimental and emergency use authorizations, and the importation of products in use elsewhere in the world. Pre-approved vaccine banks provide an additional mechanism.

Serum antibody responses of cattle vaccinated with partially purified native Pasteurella haemolytica leukotoxin.

The objective of these experiments was to study the serum antibody responses of cattle to partially purified, native Pasteurella haemolytica A1 leukotoxin (LKT) formulated with a commercial aluminum hydroxide-DDA-bromide adjuvant. In two experiments, calves received two intramuscular injections 21 days apart and sera were obtained periodically. Serum antibody responses to P. haemolytica outer membrane proteins (OMPs), formalinized P. haemolytica, and LKT were determined. In Experiment A, Holstein calves (140 kg each) were vaccinated with either 10, 1.0 or 0.1 micrograms of LKT, 10(9) c.f.u. of live P. haemolytica, or adjuvanted diluent. In Experiment B, mixed-breed beef calves (200 kg each) were vaccinated with either 100, 50 or 10 micrograms of LKT, 10(9) c.f.u. live P. haemolytica, or adjuvanted diluent. Vaccination of dairy calves with 10 micrograms of partially purified LKT stimulated LKT neutralizing antibody responses similar to those stimulated by vaccination of one calf with live P. haemolytica. In Experiment B, which used larger and different breeds of cattle, two vaccinations 3 weeks apart with 50 micrograms LKT stimulated LKT neutralizing responses equivalent to or greater than those stimulated by vaccination with live P. haemolytica. In both experiments, LKT vaccines stimulated only low antibody responses to formalinized P. haemolytica or to OMPs.

Assessing public health practice: application of ten core function measures of community health in six states.

Factor analysis, combined with an evaluation of item difficulty and discrimination, can provide useful insights in questionnaire development. In 1993, as part of a study to develop a questionnaire to assess performance of the core functions of public health at a community level, 370 local health departments (LHDs) in six states completed a 26-item questionnaire (94% response). This study describes factor analysis results after controlling for item difficulty and discrimination. Fifteen items had intermediate difficulty and fair-to-good discrimination. Factor analysis of these 15 items identified four factors. Three of these factors included items from more than one of the core functions. These findings pose an interesting question for future research: are the core functions of public health better conceived as three discrete, distinguishable factors or as three interlocking factors that form a single, seamless unit?

Growth-condition dependent expression of Pasteurella haemolytica A1 outer membrane proteins, capsule, and leukotoxin.

Pasteurella haemolytica, strain P1148 (biotype A, serotype 1) was grown under iron-rich and iron-restricted conditions both with and without serum, and the outer membrane protein (OMP), capsule, and leukotoxin production studied. OMPs were evaluated by SDS-PAGE and examined by immunoblot to identify antigens recognized by sera from P. haemolytica A1 convalescent and vaccinated cattle. Capsule production was evaluated using fluorescent antibody staining and rapid plate agglutination reaction. Leukotoxin production was measured by neutrophil 51Cr-release assay. Expression of specific OMPs, amount and antigenic character of capsule, and quantity of leukotoxin produced by P. haemolytica A1 varied in response to alterations in the growth media. Immunoblots indicated the immune response of convalescent calves differs from vaccinated calves, and convalescent calves produce antibodies to novel OMPs induced by growth in iron-restricted conditions.

Intra-abdominal hemorrhage associated with a granulosa-thecal cell neoplasm in a mare.

A 9-year-old American Saddlebred mare was referred because of abdominal distention and signs of abdominal pain. Copious peritoneal fluid obtained by abdominocentesis appeared to be frank blood. Rectal and ultrasonographic evaluation of the abdomen revealed a large mass at the distal tip of the right uterine horn. The mare was euthanatized and necropsied and the mass was determined to be a granulosa-thecal cell neoplasm. The most common clinical sign of granulosa-thecal cell neoplasm is infertility or abnormal sexual behavior. Hemoperitoneum is infrequently associated with neoplasms in horses.

Amphotericin B plus 1,3-bis (2-chloroethyl)-1-nitrosourea (BCNU-NSC no. 409962) in advanced cancer. Phase I and preliminary phase II results.

Twenty-one patients with advanced metastatic cancer received amphotericin B (AmB) plus BNUC in a Phase I chemotherapy trial. Of 11 patients with measurable metastases from bronchogenic carcinoma, five had partial antitumor responses lasting 1.5 to 12+ months, and one had objective improvement. Only two of six patients with other types of tumors had objective improvement of short duration. No consistent evidence of immunologic stimulation was observed in eight patients studied. These results suggest that amphotericin B may increase the therapeutic ratio of BCNU, and further trials of this new concept in chemotherapy of advanced tumors are in progress. The dose-limiting toxicity was myelosuppression, usually thrombocytopenia. No enhancement of BCNU toxicity by the addition of AmB was observed. The recommended dose for future studies is: AmB, 7.5 mg/m2 on day 1, 15 mg/m2 on day 1, 30 mg/m2 on days 3 and 4; plus BCNU, 250 mg/m3 on day 4. The regimen is repeated every 6 to 8 weeks.