39 research outputs found

    Pilot Scale Production of Highly Efficacious and Stable Enterovirus 71 Vaccine Candidates

    Get PDF
    BACKGROUND: Enterovirus 71 (EV71) has caused several epidemics of hand, foot and mouth diseases (HFMD) in Asia and now is being recognized as an important neurotropic virus. Effective medications and prophylactic vaccine against EV71 infection are urgently needed. Based on the success of inactivated poliovirus vaccine, a prototype chemically inactivated EV71 vaccine candidate has been developed and currently in human phase 1 clinical trial. PRINCIPAL FINDING: In this report, we present the development of a serum-free cell-based EV71 vaccine. The optimization at each step of the manufacturing process was investigated, characterized and quantified. In the up-stream process development, different commercially available cell culture media either containing serum or serum-free was screened for cell growth and virus yield using the roller-bottle technology. VP-SFM serum-free medium was selected based on the Vero cell growth profile and EV71 virus production. After the up-stream processes (virus harvest, diafiltration and concentration), a combination of gel-filtration liquid chromatography and/or sucrose-gradient ultracentrifugation down-stream purification processes were investigated at a pilot scale of 40 liters each. Although the combination of chromatography and sucrose-gradient ultracentrifugation produced extremely pure EV71 infectious virus particles, the overall yield of vaccine was 7-10% as determined by a VP2-based quantitative ELISA. Using chromatography as the downstream purification, the virus yield was 30-43%. To retain the integrity of virus neutralization epitopes and the stability of the vaccine product, the best virus inactivation was found to be 0.025% formalin-treatment at 37 °C for 3 to 6 days. Furthermore, the formalin-inactivated virion vaccine candidate was found to be stable for >18 months at 4 °C and a microgram of viral proteins formulated with alum adjuvant could induce strong virus-neutralizing antibody responses in mice, rats, rabbits, and non-human primates. CONCLUSION: These results provide valuable information supporting the current cell-based serum-free EV71 vaccine candidate going into human Phase I clinical trials

    International Consensus Statement on Rhinology and Allergy: Rhinosinusitis

    Get PDF
    Background: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR‐RS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICAR‐RS‐2021 as well as updates to the original 140 topics. This executive summary consolidates the evidence‐based findings of the document. Methods: ICAR‐RS presents over 180 topics in the forms of evidence‐based reviews with recommendations (EBRRs), evidence‐based reviews, and literature reviews. The highest grade structured recommendations of the EBRR sections are summarized in this executive summary. Results: ICAR‐RS‐2021 covers 22 topics regarding the medical management of RS, which are grade A/B and are presented in the executive summary. Additionally, 4 topics regarding the surgical management of RS are grade A/B and are presented in the executive summary. Finally, a comprehensive evidence‐based management algorithm is provided. Conclusion: This ICAR‐RS‐2021 executive summary provides a compilation of the evidence‐based recommendations for medical and surgical treatment of the most common forms of RS

    Outdoor Fitness Equipment Usage Behaviors in Natural Settings

    No full text
    Outdoor fitness equipment (OFE) areas have become a popular form of built environment infrastructure in public open spaces as a means to improve public health through increased physical activity. However, the benefits of using OFE are not consistent, and several OFE accidents have been reported. In this study, we videotaped how OFE users operate OFE in parks and selected four types of popular OFE (the waist twister, air walker, ski machine, and waist/back massager) for video content analysis. Furthermore, we established coding schemes and compared results with the instructions provided by OFE manufacturers. The results revealed various usage behaviors for the same OFE types. In addition, we observed that a significant portion of user behaviors did not follow manufacturers’ instructions, which might pose potential risks or actually cause injuries. Children are especially prone to act improperly. This study provides empirical evidence indicating the existence of potential safety risks due to inappropriate usage behaviors that might lead to accidents and injuries while using OFE. This study provides crucial information that can be used to evaluate the effectiveness of OFE and to develop future park or open space initiatives

    Does the use of outdoor fitness equipment by older adults qualify as moderate to vigorous physical activity?

    No full text
    <div><p>Despite the rapid worldwide expansion of parks with outdoor fitness equipment (OFE), no objective data regarding the intensity of activity associated with using OFE are available. Hence, this study quantified the energy expenditure and intensity of physical activity by examining four outdoor fitness devices widely used by older adults and provides objective evidence-based intensity references for the Compendium of Physical Activities. Sixteen older adults (mean age: 70.7 ± 5.6 yr) equipped with a portable metabolic system for measuring energy expenditure and activity intensity completed tasks while walking or using four types of OFE. Descriptive statistics and repeated-measures ANOVA with the Bonferroni post hoc test were employed. The energy expenditure and activity intensity for using an air walker at tempos of 80, 100, and 120 bpm were 50.78 ± 14.76 (2.81 ± 0.85), 59.62 ± 14.23 (3.26 ± 0.82), and 65.62 ± 18.27 (3.55 ± 1.02) cal/kg/min (METs), respectively. The induced energy and intensity output values for a ski machine were 54.00 ± 14.31 (3.02 ± 0.87), 68.87 ± 22.74 (3.82 ± 1.35), and 74.55 ± 23.39 (4.05 ± 1.35) cal/kg/min (METs), at 80, 100, and 120 bpm, respectively. The energy output for a waist twister at 60 bpm was 38.43 ± 20.16 cal/kg/min (2.05 ± 1.15 METs), and that for a double arm stretch at 80 bpm was 31.05 ± 12.58 cal/kg/min (1.63 ± 0.70 METs). These findings indicate that activity on the ski machine and air walker could be considered to have moderate intensity, whereas the intensity of activity on the waist twister and double arm stretch was significantly lower than that for walking at either 3.2 km/h or 4 km/h and could be considered only light intensity. The MET values for the OFE were lower than those for similar indoor fitness equipment. The results of this study provide crucial implications for public health practices concerning the development of active living environments.</p></div

    Who Is Using Outdoor Fitness Equipment and How? The Case of Xihu Park

    No full text
    Outdoor fitness equipment (OFE) placed in public parks has the potential to encourage physical activity. However, little is known about OFE users and use patterns. This study employed onsite and video observations of OFE usage to describe user characteristics and patterns in Xihu Park. Results indicate that OFE in this park attracted considerable use, particularly in the early morning and late afternoon. During these peak-hour observations, approximately 12 users per hour used the OFE, with the majority being females and seniors. The triple arm stretch and air walker were the most popular stations. However, most OFE users interacted with less than three of the available six OFE stations. Furthermore, users spent an average of less than nine minutes on all OFE stations combined. While OFE equipment was well-used in this urban park, it appears users did not interact with OFE at rates to produce a sufficient bout or level of physical activity during their park visit. Further investigations of OFE are encouraged to determine their health impact

    Descriptive statistics of the participants and differences between men and women determined using the t test.

    No full text
    <p>Descriptive statistics of the participants and differences between men and women determined using the t test.</p
    corecore