Assessment of CD8 T-cell mediated immunity in an influenza A(H3N2) human challenge model in Belgium: a single centre, randomised, double-blind phase 2 study.

Background: Protection afforded by inactivated influenza vaccines can theoretically be improved by inducing T-cell responses to conserved internal influenza A antigens. We assessed whether, in an influenza controlled human infection challenge, susceptible individuals receiving a vaccine boosting T-cell responses would exhibit lower viral load and decreased symptoms compared with placebo recipients.

Methods: In this single centre, randomised, double-blind phase 2 study, healthy adult (aged 18-55 years) volunteers with microneutralisation titres of less than 20 to the influenza A(H3N2) challenge strain were enrolled at an SGS quarantine facility in Antwerp, Belgium.

Report on eighth WHO meeting on development of influenza vaccines that induce broadly protective and long-lasting immune responses: Chicago, USA, 23-24 August 2016.

In August 2016, the World Health Organization (WHO) convened the "Eighth meeting on development of influenza vaccines that induce broadly protective and long-lasting immune responses" to discuss the regulatory requirements and pathways for licensure of next-generation influenza vaccines, and to identify areas where WHO can promote the development of such vaccines. Participants included approximately 120 representatives of academia, the vaccine industry, research and development funders, and regulatory and public health agencies. They reviewed the draft WHO preferred product characteristics (PPCs) of vaccines that could address prioritized unmet public health needs and discussed the challenges facing the development of such vaccines, especially for low- and middle-income countries (LMIC).

Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus.

Preclinical development of and research on potential Middle East respiratory syndrome coronavirus (MERS-CoV) medical countermeasures remain preliminary; advancements are needed before most countermeasures are ready to be tested in human clinical trials. Research priorities include standardization of animal models and virus stocks for studying disease pathogenesis and efficacy of medical countermeasures; development of MERS-CoV diagnostics; improved access to nonhuman primates to support preclinical research; studies to better understand and control MERS-CoV disease, including vaccination studies in camels; and development of a standardized clinical trial protocol. Partnering with clinical trial networks in affected countries to evaluate safety and efficacy of investigational therapeutics will strengthen efforts to identify successful medical countermeasures.

Synthetic generation of influenza vaccine viruses for rapid response to pandemics.

During the 2009 H1N1 influenza pandemic, vaccines for the virus became available in large quantities only after human infections peaked. To accelerate vaccine availability for future pandemics, we developed a synthetic approach that very rapidly generated vaccine viruses from sequence data. Beginning with hemagglutinin (HA) and neuraminidase (NA) gene sequences, we combined an enzymatic, cell-free gene assembly technique with enzymatic error correction to allow rapid, accurate gene synthesis.

The future of cell culture-based influenza vaccine production.

Influenza vaccines have been prepared in embryonated chicken eggs and used for more than 60 years. Although this older technology is adequate to produce hundreds of millions of doses per year, most viral vaccines are now being produced in cell culture platforms. The question of whether egg-based influenza vaccines will continue to serve the needs of the growing influenza vaccine market is considered here.

Paradoxical response to a novel influenza virus vaccine strain: the effect of prior immunization.

Background: repeated influenza immunization does not appear to adversely affect the serum antibody response to new influenza strains.

Objective: to determine whether the immune response to a new influenza strain was inferior in persons previously vaccinated compared with persons not previously vaccinated.

Design: randomized, double-blind clinical trial.

Interview with Avedis Donabedian, M.D. Interview by Gordon Brown.

Avedis Donabedian was born in Beirut, Lebanon, grew up in a small town north of Jerusalem, and returned to Beirut to obtain his B.A. and M.

Preparation and characterization of a purified influenza virus neuraminidase vaccine.

Influenza virus neuraminidase (NA) has been shown to induce protective but infection-permissive immunity in experimental animals. Challenge infection following such immunization is attended by decreased viral replication and disease manifestations but is sufficient to provide antigenic stimulation and definitive immunity to the virus. The present report describes the preparation and characterization of a purified NA vaccine (NAV) used in Phase 1 (immunogenicity and toxicity) trials in humans.

Effectiveness of computer-aided learning in community health nursing.

The authors report an evaluation of one experience in computer-aided learning, with an attempt to ascertain its effectiveness in adding to knowledge or changing attitudes about selected aspects of the diagnosis and management of breast cancer in women. The authors also discuss how much a selected group of senior nursing students knew about the subject before embarking on the exercise in computer-aided learning.

[Priorities of progress in evaluating and monitoring quality of care].

This paper discusses the following priorities: redefining and widening the scope of assessment, redefining assessment methods, redesigning and evaluating quality assurance systems, promoting consumer participation, professionalizing quality assurance, and creating a supportive culture. The article proposes empirical assessment of quality assurance methods as the highest priority. It concludes with the idea that seeking quality is the ethical dimension of professional life.

Health science information management. An approach to improving QA and clinical practice.

To help quality assurance (QA) professionals and clinical practitioners keep up with advances in health care knowledge and technology, we describe a prototype Health Science Information Management (HSIM) publication. We conceptualize HSIM to include: (a) identification of unique science information needs; (b) rapid retrieval of valid needed information; and (c) use the information to improve health care benefits. To more adequately accomplish these functions, we suggest that five specific categories of information will be essential: (1) reports of recent advances in Science Information Management methods; (2) original reports of Science Information Syntheses (SISs) providing information immediately applicable for QA; (3) previously published reports of "classic" SISs relevant to QA; (4) reviews of new technologies and products immediately applicable to quality management; (5) cumulative indexing of the above methods and products.

Quality and cost: choices and responsibilities.

Practitioners are at least obligated to provide the most effective care most efficiently. But when added benefits are small relative to added cost, practitioners may stop short of the most effective care in obedience to patient preferences. If payers impose a different standard of optimal care, I suggest that health care professionals will respond in one of three ways: oppose intervention, adopt the economic optimum, or take an intermediate position by accepting the payer's specification of optimal care but safeguarding the individual practitioner's role as an advocate for each patient and the profession's role as an advocate of its view of the public good.