Safety and immunogenicity of a novel nanoemulsion mucosal adjuvant W805EC combined with approved seasonal influenza antigens

Background

Improving the systemic and mucosal immune response following intranasal vaccination could enhance disease protection against respiratory pathogens. We assessed the safety and immunogenicity of a novel nanoemulsion mucosal adjuvant W₈₀5EC combined with approved seasonal influenza antigens.

Methods

This was a first-in-human Phase I study in 199 healthy adult volunteers randomized to receive a single intranasal administration of 5%, 10%, 15% or 20% W₈₀5EC, combined with 4 or 10 μg strain-specific Fluzone^® HA, compared with intranasal PBS, intranasal Fluzone^®, or 15 ug strain-specific intramuscular Fluzone^®. Safety was evaluated by physical examination, laboratory parameters, symptom diaries, and adverse event reports. Serum HAI titers and nasal wash IgA were assessed at baseline as well as 28 and 60 days after vaccination.

Results

W₈₀5EC adjuvant combined with seasonal influenza antigens was well tolerated without safety concerns or significant adverse events. The highest dose of 20% W₈₀5EC combined with 10 μg strain-specific HA elicited clinically meaningful systemic immunity based on increases in serum HAI GMT and ≥70% seroprotection for all 3 influenza strains, as well as a rise in antigen-specific IgA in nasal wash specimens.

Conclusions

W₈₀5EC adjuvant was safe and well tolerated in healthy adult volunteers and elicited both systemic and mucosal immunity following a single intranasal vaccination.     

Association between obesity and vulnerability and serologic response to influenza vaccination in older adults

Background

Serologic response to influenza vaccination declines with age. Few other host factors are known to be associated with serologic response. Our objective was to determine whether obesity and vulnerability independently predicted serologic response to influenza vaccination.

Methods

Adults ≥50 years were recruited during the 2008–2009 influenza season. Subjects provided pre- and post-vaccination sera for measuring antibody titers to 2008–2009 vaccine components. Body mass index (BMI) was calculated as weight (kg)/height (m²). Data were collected on vulnerability using the vulnerable elders survey (VES13). Logistic regression evaluated the associations between obesity and vulnerability and the serologic response to vaccination (both seroprotection and seroconversion), adjusting for gender, age, comorbidities, pre-vaccination titer, and site.

Results

Mean (±standard deviation) age of 415 study subjects was 65 ± 10 years; 40% were obese. Mean BMI was 29 ± 5.6 kg/m²; mean VES13 was 1.6 ± 1.8. The proportions of subjects who seroconverted and had seroprotective titers were 40% and 49%, respectively, for A/Brisbane/59 (H1N1); 73% and 80% for A/Brisbane/10 (H3N2); and 34% and 94% for B/Florida. Modified VES-13 (score 0–10, with 10 being most vulnerable) was not associated with seroprotection against H1N1 or H3N2, and VES-13 was directly associated with seroconversion to H1N1 but not H3N2 or B. Obesity (BMI ≥ 30 kg/m² vs. BMI 18.5–30 kg/m²) was not associated with seroprotection for H1N1 or H3N2; obesity was directly associated with seroconversion to H3N2 but not H1N1 or B. Age was inversely associated with seroprotection and seroconversion against H1N1 and with seroconversion to influenza B.

Conclusion

Based on this sample of older healthy subjects, there were no consistent relationships between VES 13 or obesity and either seroprotection or seroconversion to three influenza vaccine antigens.     

Fibrosis and inflammatory activity in noncancerous tissue and mitotic index of cancer tissue in patients with hepatocellular carcinoma: relationship to clinicopathological factors and prognosis after hepatic resection

This study was designed to provide a histopathological analysis focusing on fibrosis (staging) and necroinflammatory reaction (grading, hepatitis activity index: HAI) in noncancerous liver tissue, and mitotic index (MI) in cancerous liver tissue to predict prognosis in 81 patients with chronic hepatitis or cirrhosis who underwent hepatectomy for hepatocellular carcinoma (HCC). The incidence of grade 2/3 and higher HAI was higher in patients with viral hepatitis C. The incidence of grade 2/3 was associated with vascular invasion of HCC, postoperative liver dysfunction, and cancer recurrence. Higher MI (5) was significantly associated with vascular invasion, poor histological differentiation, and recurrence rate (P < 0.05). Multivariate analysis showed that higher grade was the factor strongly associated with cancer recurrence (odds ratio: 10.621, P = 0.006). Higher MI correlated with overall patient survival (P < 0.05) by univariate analysis. Grading and MI are the useful prognostic markers for predicting tumor recurrence and patient survival.     

Back to Basics: Preventing Surgical Site Infections

A surgical site infection (SSI) is an unintended and oftentimes preventable consequence of surgery. There is a significant amount of literature related to preventing SSIs, and it is up to practitioners in each care setting to review the evidence and work together to implement SSI prevention measures, such as nasal decolonization, antibiotic prophylaxis, preoperative showers, preoperative oxygen supplementation, and antimicrobial sutures. In addition, practitioners can follow several recommendations to reduce the risk of SSIs, including following proper hand hygiene practices; wearing clean, facility-laundered scrub attire; following a surgical safety checklist; and speaking up when a break in sterile technique is witnessed. The benefits of preventing SSIs are preventing patient mortality and decreasing the burden that SSIs pose on the national health care system. It is up to health care leaders to drive and support SSI prevention initiatives.     

Superiority of tissue-culture-grown antigens over egg-grown antigens for serologic diagnosis of influenza B virus infections

Acute and convalescent sera obtained from 10 adults and 21 children who were infected with influenza B virus were tested by hemagglutination inhibition. Of four antigens used, two tissue-culture-grown antigens were superior to either egg-grown or egg-grown, ether-treated antigens in detecting fourfold antibody rise during influenza B virus infection.     

Vaccination during pregnancy to protect infants against influenza: why and why not?

Influenza is a significant cause of morbidity and mortality for pregnant women and infants worldwide. Influenza vaccination during pregnancy has been shown to be safe and highly effective and should be recommended for all pregnant women before the influenza season. Despite existing recommendations, the vaccine is underused in most countries. Obstacles to immunization include insufficient awareness of the disease burden and of the importance and safety of immunization, fear of liability and the wish to minimize interventions during pregnancy. Therefore, educational interventions for the public and health care workers are necessary to increase protection of pregnant women and young infants from influenza related complications.     

Metrics and management: Two unresolved problems on the pathway to health care-associated infection elimination

Surveillance and management of health care-associated infections (HAIs) has traditionally relied on analyses of outcome data to elucidate trends in HAI incidence, discover host or treatment risk factors, and facilitate comparisons of HAI rates within and among licensed providers or facilities. This paper explores residual gaps and shortcomings associated with outcome reporting and possible sources of bias that may invalidate intra- and interfacility comparisons. As an alternative to outcome surveillance and reporting, real-time process monitoring and control is proposed. To address the need for uncompromising conformity with preventive measures, the concepts of social entropy, authority, responsibility, and accountability are explored and linked to process control at the bedside.     

An investigation of radiographers' mobile phone use and the success of an awareness campaign at reducing the nosocomial infection risks

IntroductionMobile phone use by healthcare workers (HCWs) is widespread. Studies have shown that HCW’s mobile phones can harbour pathogens associated with nosocomial infections. This study investigated whether an awareness campaign will result in an improvement in radiographers’ phone and hand hygiene practices.MethodsRadiographers working in the general department of two university hospitals were invited to participate. One hospital was assigned as the experiment hospital and the other as a control. In the experiment hospital, adenosine triphosphate (ATP) testing of each participant’s mobile phone determined the cleanliness of its surface. A corresponding survey was completed to determine their current practices and level of awareness. Subsequently, an infection control poster campaign took place for a one-month period, followed by re-testing. In the control hospital, the ATP testing and survey were also completed before and after a one-month period, but without a poster campaign.ResultsRadiographers were generally unaware of the infection risks associated with mobile phone use with 44% of all participants never cleaning their phone. The campaign successfully improved phone hygiene frequency and method in the experiment hospital. However, it did not improve hand hygiene practices and actual phone cleanliness (mean ATP count reductions of 10% (experiment hospital) and 20% (control)). The ATP testing as a less direct form of intervention showed similar levels of success in comparison to the poster campaign.ConclusionsA multifaceted educational approach is likely to be most effective in raising awareness and changing radiographers’ phone and hand hygiene practices.     

兔出血症病毒抗体的实验室检测能力验证结果评价

【摘要】 目的 通过兔出血症病毒抗体检测能力验证计划,了解实验动物检测机构检验能力,提高实验动物质量检测水平。方法 按照CNAS批准的能力验证方案,通过筛选血清制备样品,经过稳定性和均匀性检验合格,作为能力验证样品。采用随机编号,发样给参加单位,并附作业指导书。在规定时限提交检验报告和原始记录复印件,其结果与样品预检结果一致的判为满意结果,不一致或未能提交结果的判为不满意结果。结果 来自14个省市自治区的20个实验室报名参加本次比对实验,均在规定时间内反馈了检测结果,17个实验室检测结果为合格或优秀,占参加比对实验室的85%。在20个实验室中,14个实验室采用了酶联免疫吸附实验（ELISA）方法,6个实验室采用血凝抑制实验（HAI）方法。结论 全国各实验动物检测机构兔出血症病毒抗体总体检测能力较高,实施能力验证计划能够反映实验室的检测水平。