Influenza and respiratory syncytial virus in infants study (IRIS) of hospitalized and non-ill infants aged <1 year in four countries: study design and methods

BMC Infectious Diseases

Study Protocol

Danielle R. Hunt¹  Pat Shifflett¹  Carolyn Kulb¹  Basima I. Marar²  Silvia Bino³  Artan Simaku³  Majlinda Dhimolea⁴  Aubree Gordon⁵  Natalie J. Thornburg⁶  Susan I. Gerber⁶  Holly M. Biggs⁶  Felix Sanchez⁷  Eduardo Azziz-Baumgartner⁸  Min Z. Levine⁸  Mark G. Thompson⁹  Angel Balmaseda^1,10  Jennifer K. Meece^1,11  Ilirjana Bakalli^1,12  Marilla G. Lucero^1,13  Veronica L. Tallo^1,13  Joanne N. de Jesus^1,13  Eric A. F. Simões^1,14  Lionel Gresh^1,15  Ilham Abu Khader^1,16  Tareq M. Al-Sanouri^1,16  Ali K. Arbaji^1,16 

[1] Abt Associates, Inc, Atlanta, GA, USA;Al-Bashir Hospital, Amman, Jordan;Department of Epidemiology & Control of Infectious Diseases, Institute of Public Health, Tirana, Albania;Department of Epidemiology & Control of Infectious Diseases, Virology Laboratory, Institute of Public Health, Tirana, Albania;Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, USA;Division of Viral Diseases, CDC, Atlanta, GA, USA;Hospital Infantil Manuel de Jesús Rivera, Ministry of Health, Managua, Nicaragua;Influenza Division, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA;Influenza Division, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA;Influenza Division, MS A-32, National Center for Immunization and Respiratory Disease, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, 30333, Atlanta, GA, USA;Laboratorio Nacional de Virología, Centro Nacional de Diagnóstico y Referencia, Ministry of Health, Managua, Nicaragua;Marshfield Clinic Research Foundation, Marshfield, WI, USA;Pediatric Hospital, University Hospital Centre, Tirana, Albania;Research Institute for Tropical Medicine, Department of Health, Muntinlupa City, Metro Manila, Philippines;Section of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA;Center for Global Health, Department of Epidemiology, Colorado School of Public Health, Aurora, Colorado, USA;Sustainable Sciences Institute, Managua, Nicaragua;The Eastern Mediterranean Public Health Network (EMPHNET), Amman, Jordan;

关键词: Infant;    Influenza;    Respiratory syncytial virus;    Hospital;    Burden;    Serology;   

DOI  :  10.1186/s12879-017-2299-7

 received in 2016-11-29, accepted in 2017-03-01,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThis multi-country prospective study of infants aged <1 year aims to assess the frequency of influenza virus and respiratory syncytial virus (RSV) infections associated with hospitalizations, to describe clinical features and antibody response to infection, and to examine predictors of very severe disease requiring intensive care.Methods/DesignWe are enrolling a hospital-based cohort and a sample of non-ill infants in four countries (Albania, Jordan, Nicaragua, and the Philippines) using a common protocol. We are currently starting year 2 of a 2- to 3-year study and will enroll approximately 3,000 infants hospitalized for any acute illness (respiratory or non-respiratory) during periods of local influenza and/or RSV circulation. After informed consent and within 24 h of admission, we collect blood and respiratory specimens and conduct an interview to assess socio-demographic characteristics, medical history, and symptoms of acute illness (onset ≤10 days). Vital signs, interventions, and medications are documented daily through medical record abstraction. A follow-up health assessment and collection of convalescent blood occurs 3-5 weeks after enrollment. Influenza and RSV infection is confirmed by singleplex real time reverse transcriptase polymerase chain reaction (rRT-PCR) assays. Serologic conversion will be assessed comparing acute and convalescent sera using hemagglutination inhibition assay for influenza antibodies and enzyme-linked immunosorbent assay (ELISA) for RSV. Concurrent with hospital-based enrollment, respiratory specimens are also being collected (and tested by rRT-PCR) from approximately 1,400 non-ill infants aged <1 year during routine medical or preventive care.DiscussionThe Influenza and RSV in Infants Study (IRIS) promises to expand our knowledge of the frequency, clinical features, and antibody profiles of serious influenza and RSV disease among infants aged <1 year, quantify the proportion of infections that may be missed by traditional surveillance, and inform decisions about the potential value of existing and new vaccines and other prevention and treatment strategies.

【 授权许可】

CC BY   
© The Author(s). 2017