Enterotoxin-producing Escherichia coli O169:H41, United States

From 1996 to 2003, 16 outbreaks of enterotoxigenic Escherichia coli (ETEC) infections in the United States and on cruise ships were confirmed. E. coli serotype O169:H41 was identified in 10 outbreaks and was the only serotype in 6. This serotype was identified in 1 of 21 confirmed ETEC outbreaks before 1996

Regulatory Aspects on the Use of Fish Embryos in Environmental Toxicology

Animal alternative tests are gaining serious consideration in an array of environmental sciences, particuarly as they relate to sound management of chemicals and wastewater discharges. The ILSI Health and Environmental Sciences Institute and the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) held an International Workshop on the Application of the Fish Embryo Test in March 2008. This relatively young discipline is following advances in animal alternatives for human safety sciences and it is advisable to develop a broad comparison of how animal alternative tests involving fish are viewed in a regulatory context over a wide array of authorities or advising bodies. These include OECD, Western Europe, North America, and Japan. This paper summarizes representative practices from these regions. Presently, the global regulatory environment has varying stances regarding the protection of fish for use as an experimental animal. Approaches in Europe are more restrictive and provide the greatest protection to fish, followed by North America and Japan. Such differences have a long-term potential to lead to a lack of harmony in approaches to fish toxicity testing especially for chemicals in commerce across multiple geographic regions. Implementation of alternative methods and approaches will be most successful if accepted globally, including methods in fish toxicity testing. An important area for harmonization would be in the interpretation of protected and non-protected life stages of fish. Use of fish embryos represent a promising alternative and allow bridging to more technically challenging alternatives with longer prospective timelines including cell-based assays, ecotoxicogenomics, and QSARs.JRC.DG.I.3-In-vitro method

Assessable learning outcomes for the EU Education and Training Framework core and Function A specific modules: Report of an ETPLAS WORKING Group

Article 23(2) of the European Union Directive 2010/63/EU, which regulates welfare provisions for animals used for scientific purposes, requires that staff involved in the care and use of animals for scientific purposes be adequately educated and trained before they undertake any such work. However, the nature and extent of such training is not stipulated in the Directive. To facilitate Member States in fulfilling their education and training obligations, the European Commission developed a common Education and Training Framework, which was endorsed by the Member States Competent Authorities. An Education & Training Platform for Laboratory Animal Science (ETPLAS) Working Group was recently established to develop further guidance to the Learning Outcomes in the Framework, with the objective to clarify the levels of knowledge and understanding required by trainees, and to provide the criteria by which these Learning Outcomes should be assessed. Using the Framework document as a starting point, assessment criteria for the Learning Outcomes of the modules required for Function A persons (carrying out procedures on animals) for rats, mice and zebrafish were created with sufficient detail to enable trainees, providers and assessors to appreciate the level of knowledge, understanding and skills required to pass each module. Adoption and utilization of this document by training providers and accrediting or approving bodies will harmonize introductory education and training for those involved in the care and use of animals for scientific purposes within the European Union, promote mutual recognition of training within and between Member States and therefore free movement of personnel

Knowledge, attitudes and beliefs about HIV infection and AIDS among healthy factory workers and their wives, Kinshasa, Zaire

As a first step in designing an AIDS prevention program at a large factory in Kinshasa, Zaire, we collected information on attitudes towards human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) from factory foremen and their wives. Trained moderators conducted twelve focus group discussions (from November through December 1987) that addressed knowledge, attitudes and beliefs about HIV infection and AIDS. In general, participants were familiar with HIV infection and AIDS and considered these conditions leading health problems in Kinshasa. Although participants had a fairly accurate understanding of the causes of HIV infection, modes of transmission and preventive measures, many myths and misconceptions existed. Many participants did not believe that condom use would consistently prevent infection through sexual intercourse. Participants strongly favored the counseling of seropositive persons but showed less consensus about whether the spouse of a seropositive person should be notified of the partner's test result. Participants predicted that couples in which one member is seropositive and the other is not would experience marital discord and friction with family, neighbors and co-workers. These findings were applied to the development of a counseling and educational program for seropositive factory employees and their spouses.AIDS health education counseling focus group research

Sex Inclusive Research Framework (SIRF): an evaluation tool to assess whether an in vivo research proposal follows the sex inclusive research philosophy.

A new, interactive framework supports the evaluation of in vivo and ex vivo research proposals from a sex inclusive research perspective delivering a traffic light classification, indicating whether a proposal is appropriate, risky, or insufficient with regards to sex inclusion. This tool is designed for use by researchers, (animal) ethical review boards, and funders to generate a rigorous and reproducible assessment of sex inclusion at the proposal level, thus helping address the embedded sex bias in preclinical research

NI-0801, an anti-chemokine (C-X-C motif) ligand 10 antibody, in patients with primary biliary cholangitis and an incomplete response to ursodeoxycholic acid

NI-0801 is a fully human monoclonal antibody against chemokine (C-X-C motif) ligand 10 (CXCL10), which is involved in the recruitment of inflammatory T cells into the liver. The safety and efficacy of NI-0801 was assessed in patients with primary biliary cholangitis. In this open-label phase 2a study, patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid received six consecutive intravenous administrations of NI-0801 (10 mg/kg) every 2 weeks. Patients were followed up for 3 months after the last infusion. Liver function tests, safety assessments, as well as pharmacokinetic and pharmacodynamic parameters were evaluated at different time points throughout the dosing period and the safety follow-up period. Twenty-nine patients were enrolled in the study and were treated with NI-0801. The most frequently reported adverse events included headaches (52%), pruritus (34%), fatigue (24%), and diarrhea (21%). No study drug-related serious adverse events were reported. NI-0801 administration did not lead to a significant reduction in any of the liver function tests assessed at the end of the treatment period (i.e., 2 weeks after final NI-0801 administration) compared to baseline. Conclusion: Despite clear pharmacologic responses in the blood, no therapeutic benefit of multiple administrations of NI-0801 could be demonstrated. The high production rate of CXCL10 makes it difficult to achieve drug levels that lead to sustained neutralization of the chemokine, thus limiting its targetability. (Hepatology Communications 2018;2:492-503)