Immunomodulation profile of the biosimilar trastuzumab MYL-1401O in a bioequivalence phase I study.

The initial Phase-I single centre, single dose, randomized, double-blind, cross-over study was planned to assess the pharmacokinetic and pharmacodynamic bioequivalence of the trastuzumab biosimilar (MYL-1401O) compared to the reference Herceptin. Their respective immunomodulation profile presented in this paper involved healthy males receiving a single infusion of both monoclonals, separated by a washout period. Sixty parameters were assessed in total, including serum cytokines, peripheral mononuclear cell (PBMC) subsets, cell activation and response to recall antigens and mitogen, pre- and post- infusion, as well as a cytokine release assay (CRA) at baseline.

Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations.

Drug safety monitoring is essential for developing efficient and safe treatments. It starts with preclinical toxicology studies and continues with the observation and analysis of potentially harmful effects in humans throughout the whole drug life cycle. Safety surveillance during the clinical phase is of paramount importance for protecting the health of clinical trial (CT) participants at a period when relatively little is known about the drug safety profile, and for reassuring that detected risks are minimized when the product obtains marketing approval.

Evaluation of the discriminative performance of the prehospital National Advisory Committee for Aeronautics score regarding 48-h mortality.

Objective: The National Advisory Committee for Aeronautics (NACA) score is used by many emergency medical services to assess the severity of prehospital patients. Little is known about its discriminative performance regarding short-term mortality.

Participants And Methods: We retrospectively included adult missions between 2008 and 2014 in a Swiss ground and air-based emergency medical services.

The Candidate Blood-stage Malaria Vaccine P27A Induces a Robust Humoral Response in a Fast Track to the Field Phase 1 Trial in Exposed and Nonexposed Volunteers.

Background: P27A is an unstructured 104mer synthetic peptide from Plasmodium falciparum trophozoite exported protein 1 (TEX1), the target of human antibodies inhibiting parasite growth. The present project aimed at evaluating the safety and immunogenicity of P27A peptide vaccine in malaria-nonexposed European and malaria-exposed African adults.

Methods: This study was designed as a staggered, fast-track, randomized, antigen and adjuvant dose-finding, multicenter phase 1a/1b trial, conducted in Switzerland and Tanzania.

Hot Air Balloon: An Unusual Cause of Multicasualty Trauma Incident.

Hot air balloon incidents are few and far between compared with the total number of flights. Nevertheless, hot air balloon incidents may produce severe trauma involving several patients and are linked to significant mortality. The prehospital management of injured patients starts after having secured potential surrounding dangers, such as fire or explosion.

Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study.

Background: The ongoing Ebola outbreak led to accelerated efforts to test vaccine candidates. On the basis of a request by WHO, we aimed to assess the safety and immunogenicity of the monovalent, recombinant, chimpanzee adenovirus type-3 vector-based Ebola Zaire vaccine (ChAd3-EBO-Z).

Methods: We did this randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a trial at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

Safety of human immunisation with a live-attenuated Mycobacterium tuberculosis vaccine: a randomised, double-blind, controlled phase I trial.

Background: Tuberculosis remains one of the world's deadliest transmissible diseases despite widespread use of the BCG vaccine. MTBVAC is a new live tuberculosis vaccine based on genetically attenuated Mycobacterium tuberculosis that expresses most antigens present in human isolates of M tuberculosis. We aimed to compare the safety of MTBVAC with BCG in healthy adult volunteers.

Tick-borne pathogens in ticks collected from breeding and migratory birds in Switzerland.

From 2007 to 2010, 4558 migrating and breeding birds of 71 species were caught and examined for ticks in Switzerland. A total of 1205 specimens were collected; all were Ixodes ricinus ticks except one Ixodes frontalis female, which was found on a common chaffinch (Fringilla coelebs) for the first time in Switzerland. Each tick was analysed individually for the presence of Borrelia spp.

Implementation of a medical command and control team in Switzerland.

In case of a major incident or disaster, the advance medical rescue command needs to manage several essential tasks simultaneously. These include the rapid deployment of ambulance, police, fire and evacuation services, and their coordinated activity, as well as triage and emergency medical care on site. The structure of such a medical rescue command is crucial for the successful outcome of medical evacuation at major incidents.

[Trends in interhospital transfers from a Swiss university hospital center].

Objective: Research on interhospital transfers provides a basis for describing and quantifying patient flow and its evolution over time, offering an insight into hospital organization and management and hospital overcrowding. The purpose of this study was to conduct a qualitative and quantitative analysis of patient flow and to examine trends over an eight-year period.

Methods: A retrospective descriptive study of interhospital transfers was conducted between 2003 and 2011 based on an analysis of demographic, medical and operational characteristics.

[Exertional heatstroke].

Exertional heatstroke is defined by an increase of core body temperature above 40 degrees C and neurological symptoms in association with exercise. It is related to excessive heat production, which overwhelms the endogenous mechanisms of thermoregulation. It is observed during intense physical activity in a hot and humid environment, most commonly in untrained subjects poorly adapted to such conditions.

Monitoring of CD4+CD25highIL-7Rαhigh activated T cells in kidney transplant recipients.

Background And Objectives: In humans, circulating CD4(+)CD25(high) T cells contain mainly regulatory T cells (Treg; FoxP3(+)IL-7Rα(low)), but a small subset is represented by activated effector T cells (Tact; FoxP3(-)IL-7Rα(high)). The balance between Tact and Treg may be important after transplantation. The aim of this study was first to analyze and correlate CD4(+)CD25(high) Tact and Treg with the clinical status of kidney transplant recipients and second to study prospectively the effect of two immunosuppressive regimens on Tact/Treg during the first year after transplantation.

Electronic control device exposure: a review of morbidity and mortality.

The use of electronic control devices has expanded worldwide during the last few years, the most widely used model being the Taser. However, the scientific knowledge about electronic control devices remains limited. We reviewed the medical literature to examine the potential implications of electronic devices in terms of morbidity and mortality, and to identify and evaluate all the existing experimental human studies.

Clinical update: suspension trauma.

Objective: Suspension trauma refers to the pathophysiologic syndrome that occurs when a victim is suspended motionless in a vertical position for an extended period of time. This can occur in sports that use a harness system as well as in various occupational activities including work on high wires or helicopter rescue operations. We reviewed the scientific evidence published to date in order to improve the prevention and treatment of suspension trauma.

Hepatitis C virus infection after liver transplantation is associated with lower levels of activated CD4(+)CD25(+)CD45RO(+)IL-7ralpha(high) T cells.

The expression of interleukin 7 receptor alpha(high) (IL-7Ralpha(high)) discriminates between activated CD25(+)CD45RO(+)CD4(+) T cells [IL-7Ralpha(high) and forkhead box P3-negative (FoxP3(-))] and regulatory T cells (IL-7Ralpha(low) and FoxP3(+)). The IL-7Ralpha(high)CD25(+)CD45RO(+)CD4(+)FoxP3(-) T cell population has been shown to be expanded in the blood and tissues of patients after kidney transplantation and to contain alloreactive T cells (activated T cells). In the present study, we analyzed the distribution of IL-7Ralpha(high)CD25(+)CD45RO(+)CD4(+)FoxP3(-) T cells in the blood of 53 patients after liver transplantation.

Coordination of Emergency Medical Services for a Major Road Traffic Accident on a Swiss Suburban Highway.

On 9th April 2008 at 2:14 p.m., on the highway between Lausanne and Vevey in western Switzerland, there was a 72-car pileup including five trucks that caused one death and injured 26 others.

[Life-threatening emergencies at the office: implications for medical education and equipment of the primary care physician].

Every medical practitioner is confronted on a daily basis with emergencies. Among these, life-threatening emergencies can have disastrous consequences in term of morbidity and mortality; 22 cardiac arrests and 10 deaths were reported among the 1,650 Swiss practices during a 5 year period. The occurrence of life-threatening emergencies at the office necessitates, according to the type and place of the practice, the skills of the practitioner and the organization of his practice, the implementation of procedures, equipments (for example room equipped with a defibrillator, respiratory nebulizer, splints, emergency drugs) and specific continuous education programs that should be encouraged and made available to the whole medical corporation.

Expansion and tissue infiltration of an allospecific CD4+CD25+CD45RO+IL-7Ralphahigh cell population in solid organ transplant recipients.

It has been recently shown (Seddiki, N., B. Santner-Nanan, J.