Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico

Virus-like particles (VLPs) can be rapidly developed from influenza virus genetic sequences in order to supply vaccine after the onset of a pandemic. The safety and immunogenicity of one or two doses of a recombinant A (H1N1) 2009 influenza VLP vaccine was evaluated in a two-stage, Phase 2, randomized, double-blind, placebo-controlled study conducted in 4563 healthy adults, 18-64 years of age, during the H1N1 2009 pandemic in Mexico. In Part A, 1013 subjects were randomized into four treatment groups (5 μg, 15 μg, or 45 μg hemagglutinin [HA] VLP vaccine or placebo) and vaccinated 21 days apart, with sera collected on Days 1, 14 and 36 for hemagglutination inhibition (HAI) testing. After review of safety and immunogenicity data from Part A, additional subjects were immunized with a single dose of 15 μg VLP vaccine (N = 2537) or placebo (N = 1011) and assessed for safety in Part B. Results showed the H1N1 2009 VLP vaccine was safe and well-tolerated. Systemic solicited events were similar between placebo and VLP vaccinated groups with no vaccine-related serious adverse events. Dose response trends for solicited local adverse events were observed, with higher incidences of local pain, swelling, tenderness, and redness reported in the higher VLP dose groups (15 μg and 45 μg) compared to the placebo and 5 μg VLP groups following both vaccinations. Although the majority of local AEs were mild in severity, a dose trend in events of moderate or greater severity was also noted for these solicited events. The VLP vaccine groups demonstrated robust HAI immune responses after a single vaccination, with high rates of seroprotection (≥40 HAI titer) in 82-92% of all subjects and in 64-85% of subjects who were seronegative at the time of immunization. HAI geometric mean titers (GMTs), geometric mean ratios (GMRs) and seroconversion rates were also all statistically higher in the VLP groups compared to placebo for both post-baseline time points. Based on these data, additional clinical trials are in development to evaluate influenza vaccine candidate antigens manufactured using Spodoptera frugiperda (Sf9)/baculovirus-based VLP technology.     

Catheter use and infection reduction in plastic surgery

BACKGROUND:

Catheter-associated urinary tract infections (CAUTI) are the most common hospital-associated infection and can result in increased health care costs, morbidity and even mortality. In 2009, The Scott & White Memorial Hospital/Texas A&M Health Science Center (Texas, USA) system’s CAUTI rate placed it in the upper quartile (ie, highest rate) for the country, necessitating a system-wide change.

OBJECTIVE:

To design and implement a guideline to reduce the incidence of CAUTI.

METHODS:

A multidisciplinary team was formed and completed both a root cause analysis and a review of the available literature. Consolidating the best evidence, the team formulated a best practice guideline detailing the proper indications for insertion of, improper use of and techniques to minimize infection with catheters. Included as part of this protocol was nursing and patient education, changes in identifying patients with a catheter and automatic termination orders. Three-, six- and 12-month reviews identifying additional opportunities for improvement at the end of 2010 were completed.

RESULTS:

In 2009, the hospital’s CAUTI rate was 1.46 per 1000 catheter days. In 2011 – the first complete year of the finalized guideline – the hospital’s CAUTI rate was 0.52 per 1000 catheter days, ranking the institution in the bottom quartile (ie, lowest rate) for the country. The surgery and plastic surgery subgroup analyses also demonstrated statistically significant reduction in both catheter use and CAUTI.

CONCLUSION:

The incidence of CAUTI was successfully reduced at The Texas A&M Healthcare Center. The guideline, its development and how it applies to plastic surgery patients are discussed.     

In Vivo Evaluation of Irinotecan-Loaded QuadraSphere Microspheres for Use in Chemoembolization of VX2 Liver Tumors

PurposeTo investigate the pharmacokinetics and chemoembolization efficacy of irinotecan-loaded QuadraSphere microspheres (QSMs) in a rabbit VX2 liver tumor model.Materials and MethodsFourteen rabbits with VX2 liver tumors were divided into two groups. In the irinotecan-loaded QSM group (n = 7), 3 mg of QSMs (30–60 μm) containing 12 mg of irinotecan (0.6 mL; 20 mg/mL) were injected into the left hepatic artery. In the control group (hepatic arterial infusion [HAI] and QSMs; n = 7), 3 mg of QSMs suspended in ioxaglic acid were injected following a bolus injection of 0.6 mL of irinotecan solution (20 mg/mL). Sequential irinotecan, SN-38, and SN-38G concentration changes were measured in plasma within 24 hours and at 1 week and in tissues at 1 week. The VX2 tumor growth rates at 1 and 2 weeks were calculated from computed tomographic images.ResultsAll rabbits underwent successful embolization. Plasma irinotecan, SN-38, and SN-38G concentrations in the irinotecan-loaded QSM group showed significantly sustained release compared with the control group (P = .01). Compared with the control group, the irinotecan-loaded QSM group had significantly higher irinotecan concentration in liver tumors (P = .03) and a tendency toward higher SN-38 concentration in liver tumors (P = .29). The SN-38G tissue concentrations were below the limits of quantification. The tumor growth rate was significantly lower and the tumor necrosis rate significantly higher in the irinotecan-loaded QSM group (P = .02 and P = .01, respectively).ConclusionChemoembolization via irinotecan-loaded QSMs more effectively suppresses tumor growth than chemoembolization with unloaded QSMs after HAI. A clinical feasibility study is warranted.     

Hospital-acquired infections in the veterinary establishment

Hospital-acquired infections (HAIs) are present in both human and veterinary hospitals with data for each. There is no surveillance into the numbers and types of HAIs in veterinary establishments, but studies have found that they are a problem. This article discusses some of the more common HAIs that can occur in the veterinary establishment as well as patient risk factors and ways of minimising them so that HAIs and their consequences can be kept to a minimum.     

Report of the 5th meeting on the evaluation of pandemic influenza prototype vaccines in clinical trials: World Health Organization,Geneva, Switzerland, 12–13 February 2009

Influenza vaccines are potentially the most efficacious means of mitigating the impact of influenza pandemic and might contribute to the rapid containment of an emerging pandemic virus.