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.     

试述餐饮业和集体用餐配送单位卫生规范的制定与施行

我国首部《餐饮业和集体用餐配送单位卫生规范》于2005年6月27日由卫生部发布,并于同年10月1日起施行。该规范规定了餐饮业人员、建筑、设施、设备、工用具等的设置和卫生管理、加工操作等方面应达到的标准或要求,适用于有固定加工场所的餐饮业经营者,也适用于单位和学校的集体食堂和集体供餐企业。本文是作者对该规范的研制说明和实施建议与讨论。     

Barriers to the use of patient safety information sources by community pharmacies

BackgroundWhen patient safety information is communicated across a regulatory jurisdiction or country, the potential to enhance the safety of community pharmacy practice is significant. While there currently exists a number of sources for patient safety information (e.g., websites, safety bulletins, online tools), knowledge of the barriers that may inhibit the use of such information sources within community pharmacies is limited.ObjectiveThis research explores community pharmacy manager use of Canadian patient safety information sources and the barriers that may limit the use of such sources.MethodsA qualitative research study design using semi-structured interviews was conducted with 15 community pharmacy managers in the Halifax Regional Municipality of Nova Scotia, Canada. The study explored how pharmacists access and engage a variety of information sources, including corporate intranets, websites, and tools provided by third party data base repositories. Interview data were analyzed using thematic analysis.ResultsFive general barriers were identified: lack of time to access information sources and its contents; too many sources of available information; too much information not relevant to community pharmacy practice; complexity navigating online information sources; and lack of community pharmacy involvement in source design.ConclusionWhile pharmacies do use safety information sources to enhance practice safety, their ability to incorporate this information is inhibited by their general lack of time available to access and read safety information, lack of knowledge about where to get this information, and lack of tailored information for the community pharmacy context. Future initiatives should address increasing information awareness of available sources, consolidating and reducing information overload of such sources, and packaging information to better fit with pharmacists’ needs.     

Model for the evaluation of drug-dispensing services in primary health care

OBJECTIVE

To develop a model for evaluating the efficacy of drug-dispensing service in primary health care.

METHODS

An efficacy criterion was adopted to determine the level of achievement of the service objectives. The evaluation model was developed on the basis of a literature search and discussions with experts. The applicability test of the model was conducted in 15 primary health care units in the city of Florianópolis, state of Santa Catarina, in 2010, and data were recorded in structured and pretested questionnaires.

RESULTS

The model developed was evaluated using five dimensions of analysis for analysis. The model was suitable for evaluating service efficacy and helped to identify the critical points of each service dimension.

CONCLUSIONS

Adaptations to the data collection technique may be required to adjust for the reality and needs of each situation. The evaluation of the drug-dispensing service should promote adequate access to medications supplied through the public health system.     

Parameters and pitfalls to consider in the conduct of food additive research,Carrageenan as a case study

This paper provides guidance on the conduct of new in vivo and in vitro studies on high molecular weight food additives, with carrageenan, the widely used food additive, as a case study. It is important to understand the physical/chemical properties and to verify the identity/purity, molecular weight and homogeneity/stability of the additive in the vehicle for oral delivery. The strong binding of CGN to protein in rodent chow or infant formula results in no gastrointestinal tract exposure to free CGN. It is recommended that doses of high Mw non-caloric, non-nutritive additives not exceed 5% by weight of total solid diet to avoid potential nutritional effects. Addition of some high Mw additives at high concentrations to liquid nutritional supplements increases viscosity and may affect palatability, caloric intake and body weight gain. In in vitro studies, the use of well-characterized, relevant cell types and the appropriate composition of the culture media are necessary for proper conduct and interpretation. CGN is bound to media protein and not freely accessible to cells in vitro. Interpretation of new studies on food additives should consider the interaction of food additives with the vehicle components and the appropriateness of the animal or cell model and dose–response.     

A Three-Step Approach for Creating Successful Electronic Immunization Record Exchanges between Clinical Practice and Public Health

Population health and individual health are strengthened through proactive immunization programs. Clinicians refer to immunization records at the point of care about to decide which vaccinations their patients and families need to reduce the risk of contracting (and spreading) vaccine preventable disease (VPD). Understanding the earliest possible age intervals that are safe to administer vaccinations provides the youngest children with as much immunity as possible as early as possible. This is especially useful for children at highest risk as their visits to a medical provider may be sporadic. This, coupled with the continuous development of new and combined vaccines and complex vaccination schedules, challenges the provider to understand the appropriate vaccinations to order for their patients. Under-vaccinating increases patients’ VPD risk; over-vaccinating increases provider and consumer health care costs. Clinicians want to make the best clinical and economically responsible decisions — this is the challenge.The solution lies in providing clinicians timely and accurate vaccination data with decision support tools at the point of care. The use of Electronic Health Records (EHRs) alone cannot achieve this goal. It will take an accountable team made up of the clinician organization, their EHR vendor, and a public health agency to effectively manage immunization coverage for a patient population.This paper provides a three-step approach to establish and maintain EHR data exchanges, demonstrates the value of both clinical and technical testing prior to data exchange implementation, and discusses lessons learned. It illustrates the value of federal Meaningful Use criteria and considers how its objective to advance data exchange with public health systems increases providers’ access to timely, accurate immunization histories and achieves desired mutual health outcomes for providers and public health programs.     

Shedding of Ann Arbor strain live attenuated influenza vaccine virus in children 6-59 months of age

Background

A trivalent, Ann Arbor strain, live attenuated influenza vaccine (LAIV) is approved for use in children 24 months of age and older in a number of countries. The incidence, duration, and other parameters of viral shedding after vaccination with LAIV have not been fully described in children ≤5 years of age.

Methods

An open-label, single-arm, multicenter, phase 2 study assessed viral shedding and safety in 200 children 6-59 months of age after a single, intranasal dose of LAIV in 2006. Participants were enrolled into 2 age groups: 6-23 months (n = 100) and 24-59 months (n = 100) of age. Viral shedding, reactogenicity, and adverse events were assessed for 28 days postvaccination. Serious adverse events and significant new medical conditions were monitored for 180 days postvaccination.

Results

Viral shedding was detected by culture in 79% (95% CI, 73-84) of vaccine recipients and occurred more frequently in children 6-23 months of age (89%) compared with children 24-59 months of age (69%). In total, 157 subjects shed vaccine, which was confirmed by RT-PCR as A/H1N1 for 128 subjects, A/H3N2 for 72 subjects, and B for 74 subjects. The incidence of shedding was highest on day 2 (59% in the 6-23 month age group; 41% in the 24-59 month age group) and most shedding occurred 1-11 days postvaccination; shedding after 11 days was infrequent and occurred almost exclusively in children 6-23 months of age. Mean titers of shed vaccine virus peaked on day 2 and were generally <10^3.0 median tissue culture infective dose/mL for both groups. Reactogenicity events peaked on day 2; runny/stuffy nose was reported most frequently (63% of all subjects).

Conclusion

Most children 6-59 months of age vaccinated with Ann Arbor strain LAIV shed ≥1 vaccine virus within 11 days of vaccination. Shedding was less common in children 24-59 months of age, a population for whom LAIV is approved for use. Titers of shed vaccine were low, which may explain why secondary transmission of LAIV was observed very infrequently in a previous controlled study conducted with young children in a daycare setting.     

Human papillomavirus vaccine coverage in the United States, National Health and Nutrition Examination Survey, 2007-2008

Objectives

This study aims to estimate human papillomavirus (HPV) vaccine coverage by demographic and sexual behavior characteristics 1-2 years after vaccine licensure in a nationally representative sample of females aged 9-59 years in the United States.

Methods

In 2007-2008, a total of 2775 females aged 9-59 years responded to questions on HPV vaccine receipt in the National Health and Nutrition Examination Survey (NHANES). Demographic and sexual characteristics were evaluated for select age categories in bivariate analyses after adjusting for survey design.

Results

Overall, 15.2% of females aged 11-26 years reported HPV vaccine initiation; vaccine initiation varied significantly by age. We found no significant difference in vaccine initiation by race or poverty level in either 11-18 or 19-26-year olds. Significantly more 19-26-year olds with private insurance initiated vaccine (16.3%) than those with public insurance (4.0%) (p = 0.04). Among females aged 14-18 years, vaccine initiation was higher in those who ever had sex (28.6%) compared to those who had never had sex (17.8%) (p = 0.05).

Conclusions

These results describe HPV vaccine initiation shortly after vaccine licensure. Vaccine initiation was highest in females aged 14-18 years. Efforts should be made to increase HPV vaccine coverage for the recommended age groups.     

辨证分型联合外治及康复指导干预腰痛

腰痛多因感受寒湿,湿热,气滞血瘀,或肾亏体虚。辨证:血瘀、寒湿、湿热、肾虚。不同证型,辨证施护,使用辅助外治(腰椎牵引、手法治疗、针刺治疗、理疗)等及康复指导,施行积极有效的护理,使患者保持情绪稳定,同时从功能训练、日常生活、情志饮食的方面做好出院康复指导,以防疾病复发。