ABSTRACT
BACKGROUND: Shigella flexneri 2a lipopolysaccharide 50 is a nasally delivered subunit vaccine consisting of a macromolecular complex composed of LPS, IpaB, IpaC and IpaD. The current study examined vaccine safety and immunogenicity across a dose range and the clinical performance of a new intranasal delivery device. METHODS: Volunteers (N=36) were randomized to receive vaccine via the Dolphin™ (Valois of America, Congers, New York) intranasal spray device at one of three doses (240, 480, and 690 µg) on days 0, 14, and 28. Another group (N=8) received the 240 µg dose via pipette. Vaccine safety was actively monitored and antigen-specific humoral and mucosal immune responses were determined. RESULTS: There were no serious adverse events and the majority of adverse events (98%) were mild. Antibody secreting cells (ASC), plasma, and mucosal immune responses to Shigella antigens were detected at all three dose levels with the 690 µg dose inducing the highest magnitude and frequency of responses. Vaccination with comparable doses of Invaplex 50 via the Dolphin™ resulted in higher plasma and ASC immune responses as compared to pipette delivery. CONCLUSION: In this trial the S. flexneri 2a Invaplex 50 vaccine was safe, well-tolerated and induced robust levels of antigen-specific intestinal IgA and ASC responses. The spray device performed well and offered an advantage over pipette intranasal delivery.
Subject(s)
Antibodies, Bacterial/immunology , Antigens, Bacterial/immunology , Immunity, Mucosal/immunology , Lipopolysaccharides/immunology , Shigella Vaccines/administration & dosage , Shigella Vaccines/immunology , Shigella flexneri/immunology , Administration, Intranasal , Adolescent , Adult , Animals , Antibodies, Bacterial/blood , Antibody-Producing Cells/immunology , Double-Blind Method , Drug Administration Routes , Female , Guinea Pigs , Humans , Immunity, Humoral/immunology , Immunoglobulin A/blood , Immunoglobulin A/immunology , Immunoglobulin G/blood , Immunoglobulin G/immunology , Lipopolysaccharides/administration & dosage , Lipopolysaccharides/adverse effects , Male , Mice , Middle Aged , Nasal Sprays , Shigella Vaccines/adverse effects , Vaccination/methods , Young AdultABSTRACT
The end-of-life care model Preferred Place of Care and the philosophy known as person-centred planning both aim to make patient choices and views central to any service delivery. This article compares the two strategies.
Subject(s)
Disabled Persons/psychology , Learning Disabilities , Terminal Care , Choice Behavior , Disabled Persons/legislation & jurisprudence , Humans , Learning Disabilities/nursing , Learning Disabilities/psychology , Mental Competency/legislation & jurisprudence , Mental Competency/psychology , Models, Nursing , Models, Organizational , Patient Advocacy , Patient Care Planning/organization & administration , Patient Participation/legislation & jurisprudence , Patient Participation/methods , Patient Participation/psychology , Patient-Centered Care/organization & administration , Philosophy, Nursing , Practice Guidelines as Topic , Terminal Care/organization & administration , Terminal Care/psychology , Total Quality Management , United KingdomABSTRACT
St Nicholas's Hospice recognized that its non-clinical staff needed support and guidance regarding the management of particularly difficult telephone conversations. It is understandable that patients and family members who are experiencing extreme uncertainty, fear and worry might express anger and despair, however, non-clinical staff were troubled by having to handle such raw emotions on the telephone. Despite palliative care excelling at counselling skills and training in breaking bad news, no material or courses exist to help these staff handle unanticipated distress on the telephone. A training session was established and, unexpectedly, many clinical staff enrolled. Although a formal in-depth evaluation did not take place, participant feedback suggested it was equally beneficial to non-clinical and clinical staff. A key element of the apparent success was the interprofessional, interagency, interpersonal sharing and exchange of ideas.
