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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 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. 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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 ;360(11): Petri, Snider, Pallansch, and Haque (unpublished)
QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template produces a 36”x60” professional poster. It will save you valuable time.
QUICK TIPS (--THIS SECTION DOES NOT PRINT--) This PowerPoint template requires basic PowerPoint (version 2007 or newer) skills. Below is a list of commonly.
RESEARCH POSTER PRESENTATION DESIGN © QUICK TIPS (--THIS SECTION DOES NOT PRINT--) This PowerPoint template requires basic.
QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template produces a 36x48 inch professional poster. You can use it to create.
RESEARCH POSTER PRESENTATION DESIGN © entations.com QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template.
RESEARCH POSTER PRESENTATION DESIGN © QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template.
QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template produces a 36”x56” professional poster. It will save you valuable time.
QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint template produces a 36”x48” professional poster. It will save you valuable time placing.
RESEARCH POSTER PRESENTATION DESIGN © m QUICK TIPS (--THIS SECTION DOES NOT PRINT-- ) This PowerPoint template requires.
RESEARCH POSTER PRESENTATION DESIGN © s.com QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template.
QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template produces a 36”x60” professional poster. You can use it to create your.
QUICK DESIGN GUIDE (--THIS SECTION DOES NOT PRINT--) This PowerPoint 2007 template produces a 48”x96” professional poster. It will save you valuable time.
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