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QUICK TIPS (--THIS SECTION DOES NOT PRINT--) This PowerPoint template requires basic PowerPoint (version 2007 or newer) skills. Below is a list of commonly.

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Presentation on theme: "QUICK TIPS (--THIS SECTION DOES NOT PRINT--) This PowerPoint template requires basic PowerPoint (version 2007 or newer) skills. Below is a list of commonly."— Presentation transcript:

1 QUICK TIPS (--THIS SECTION DOES NOT PRINT--) This PowerPoint template requires basic PowerPoint (version 2007 or newer) skills. Below is a list of commonly asked questions specific to this template. If you are using an older version of PowerPoint some template features may not work properly. Using the template Verifying the quality of your graphics Go to the VIEW menu and click on ZOOM to set your preferred magnification. This template is at 100% the size of the final poster. All text and graphics will be printed at 100% their size. To see what your poster will look like when printed, set the zoom to 100% and evaluate the quality of all your graphics before you submit your poster for printing. Using the placeholders To add text to this template click inside a placeholder and type in or paste your text. To move a placeholder, click on it once (to select it), place your cursor on its frame and your cursor will change to this symbol: Then, click once and drag it to its new location where you can resize it as needed. Additional placeholders can be found on the left side of this template. Modifying the layout This template has four different column layouts. Right-click your mouse on the background and click on “Layout” to see the layout options. The columns in the provided layouts are fixed and cannot be moved but advanced users can modify any layout by going to VIEW and then SLIDE MASTER. Importing text and graphics from external sources TEXT: Paste or type your text into a pre-existing placeholder or drag in a new placeholder from the left side of the template. Move it anywhere as needed. PHOTOS: Drag in a picture placeholder, size it first, click in it and insert a photo from the menu. TABLES: You can copy and paste a table from an external document onto this poster template. To adjust the way the text fits within the cells of a table that has been pasted, right-click on the table, click FORMAT SHAPE then click on TEXT BOX and change the INTERNAL MARGIN values to 0.25 Modifying the color scheme To change the color scheme of this template go to the “Design” menu and click on “Colors”. You can choose from the provide color combinations or you can create your own. QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template produces a 100cm x100cm professional poster. It will save you valuable time placing titles, subtitles, text, and graphics. Use it to create your presentation. Then send it to PosterPresentations.com for premium quality, same day affordable printing. We provide a series of online tutorials that will guide you through the poster design process and answer your poster production questions. View our online tutorials at: http://bit.ly/Poster_creation_help (copy and paste the link into your web browser). For assistance and to order your printed poster call PosterPresentations.com at 1.866.649.3004 Object Placeholders Use the placeholders provided below to add new elements to your poster: Drag a placeholder onto the poster area, size it, and click it to edit. Section Header placeholder Move this preformatted section header placeholder to the poster area to add another section header. Use section headers to separate topics or concepts within your presentation. Text placeholder Move this preformatted text placeholder to the poster to add a new body of text. Picture placeholder Move this graphic placeholder onto your poster, size it first, and then click it to add a picture to the poster. RESEARCH POSTER PRESENTATION DESIGN © 2011 www.PosterPresentations.com © 2011 PosterPresentations.com 2117 Fourth Street, Unit C Berkeley CA 94710 posterpresenter@gmail.com Student discounts are available on our Facebook page. Go to PosterPresentations.com and click on the FB icon. Clinical Progress since May 2011 Households surveilled28,000+ Infants Screened363 Infants Enrolled215 (59% of screened) Adverse Events16 Serious Adverse Events 6 Early Withdrawals33 (15% of enrolled) Protocol Deviations204 Exploration of the biologic basis for underperformance of oral polio and rotavirus vaccines Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world compared to peers in other countries. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. The primary hypothesis of this clinical trial is that tropical enteropathy decreases the effectiveness of oral polio and rotavirus vaccines in infants by disrupting the enteric immune system. This single-blind study will enroll 1,070 healthy infants and their mothers residing in urban slums in Dhaka, Bangladesh and Kolkata, India in two prospective cohorts. The Bangladesh arm of the study, enrolling 700 infants from May 2011, will employ a 2x2 factorial study design, separately randomizing infants to receive oral rotavirus vaccine ( Rotarix ) and a boost of inactivated polio vaccine ( IPV ). The India arm of the study, enrolling 370 infants from early 2012, will randomize infants for a boost of IPV. The trial will investigate other possible causes of oral vaccine underperformance, including: malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility. Introduction Research Objectives Study Design 2 x 2 Factorial Study Design (Bangladesh) Group ARotarix + No IPV (175) Group BRotarix + with IPV boost (175) Group CNo Rotarix + No IPV (175) Group DNo Rotarix + with IPV boost (175) Progress to Date - Bangladesh Specimen Collection Infant blood 2ml – 5ml Vaccine shedding stools Study visit stools Diarrheal stools Infant urine Mother blood Mother breast milk Clinic Procedures Gestational age assessment Anthropometry: child and mother Biweekly diarrhea surveillance Laboratory Assays Vaccine Immunogenicity ALS or Elispot (Polio and Rotavirus) Polio Plasma Neutralizing Antibody Rotavirus Plasma IgA Fecal excretion of vaccine virus Fecal IgA Fecal cytokines Mother breast milk IgA Systemic Immunity Tetanus IgG Exploratory Immunology Phosphorylation of STAT proteins Tetramer-flow cytometry CyTOF mass spec based cellular analysis Gene expression Tropical Enteropathy Lactulose-Mannitol urine test Plasma α-LPS and CRP Nutritional Status Retinol, Vitamin D, Zinc, Ferritin HLA Microbiome Acknowledgements This research is funded through the generous support of Bill and Melinda Gates Foundation. Primary Objective Determine whether decreased vaccine responsiveness to oral polio or rotavirus vaccines is associated with the presence of tropical enteropathy. Secondary Objectives Determine the impact of an inactivated polio vaccine ( IPV ) boost on systemic ( neutralizing antibodies ) and mucosal immune responses ( shedding OPV vaccine virus ) to polio vaccines following vaccination with oral polio vaccine ( OPV ). Determine the efficacy of rotavirus vaccination to prevent rotavirus diarrhea. Exploratory Objectives Describe the impact on vaccine failure and tropical enteropathy due to: Breast milk and maternal antibodies Malnutrition Genetics (pending funding) Changes in gut microbiome (Jeff Gordon) Enteric Infections (Houpt: multiplex PCR) Devise novel cellular assays to explore immunologic phenotypes with vaccine failure and TE (Mark Davis, Stanford) Phospho-flow (phosphorylation of STAT proteins) Mass spec based flow cytometry (CyTOF) Combinatorial tetramers with CyTOF Gene expression Evaluate modified immunogenicity assays and biomarkers ALS vs. ELISPOT Breast milk IgA Fecal IgA Novel markers or indices of tropical enteropathy (with MAL-ED) Laboratory Progress Conducted extractions for fecal IgA analysis on: Week 6 specimens130 Week 17 specimens19 Week 18 specimens9 Shipped 252 stool specimens to the Bangladesh National Polio Lab for vaccine excretion analysis. Received preliminary results on 66 specimens. Processed 156 Week 6 blood specimens and 35 Week 18 blood specimens. Shipped 130 whole blood specimens to Children’s Hospital Oakland Research Institute for HLA analysis. Completed initial processing of 150 whole blood specimens for Phosphoflow analysis and shipped to Stanford University. Completed piloting of ALS assay for both rotavirus and polio. ICDDR,B Dhaka, BangladeshNICED Kolkata, India DesignSingle-blind randomized clinical trial 2 x 2 factorial design Prospective cohort GCP standard Single-blind randomized clinical trial Prospective cohort GCP standard InterventionOral rotavirus vaccine (Rotarix) Inactivated polio vaccine (IPV) Enrollment700 infants + mothers Enrolled at age 0-7 days Community-based recruitment 370 infants + mothers Enrolled at age 6 weeks Clinic-based recruitment Follow-up2 years Biweekly diarrhea surveillance in home 12 scheduled follow-up clinic visits All primary care provided at study clinic 1 year No diarrhea surveillance 12 scheduled follow-up clinic visits Methods Colgate ER, Kirkpatrick BD (University of Vermont); Haque R, Qadri F, Zaman K (ICDDR,B); Sur D (NICED); Czerkinsky C (IVI); Davis M (Stanford University); Gordon J (Washington University); Mychaleckyj J, Petri WA (University of Virginia) Malabsorption Compromised Immune System Permeability Environment Pathogens Diarrhea Malnutrition Genetics 700 Children N = 350 Group A Group B N = 350 Group C Group D Rotavirus Vaccine Efficacy 1 Oral Polio Vaccine Efficacy 2 Malnourished children (by HAZ) in Dhaka are more unresponsive to OPV. 1 Parashar UD, Glass RI. Rotavirus vaccines--early success, remaining questions. N Engl J Med. Mar 12 2009;360(11):1063-1065. 2 Petri, Snider, Pallansch, and Haque (unpublished)


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