{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T16:43:18Z","timestamp":1788280998185,"version":"build-2803163510"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2018,11,27]],"date-time":"2018-11-27T00:00:00Z","timestamp":1543276800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP48805"],"award-info":[{"award-number":["OPP48805"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,8,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>We evaluated a Russian-backbone, live, attenuated influenza vaccine (LAIV) for immunogenicity and viral shedding in a randomized, placebo-controlled trial among Bangladeshi children.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Healthy children received a single, intranasal dose of LAIV containing the 2011\u20132012 recommended formulation or placebo. Nasopharyngeal wash (NPW) specimens were collected on days 0, 2, 4, and 7. Reverse transcription polymerase chain reactions and sequencing identified the influenza virus (vaccine or wild-type). On days 0 and 21, blood specimens were collected to assess immunogenicity using hemagglutination inhibition, microneutralization, and immunoglobulin A (IgA) and G enzyme-linked immunosorbent assays (ELISAs); NPW specimens were also collected to assess mucosal immunogenicity using kinetic IgA ELISA.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We enrolled 300 children aged 24 through 59 months in the immunogenicity and viral shedding analyses. Among children receiving LAIV, 45% and 67% shed A\/H3N2 and B vaccine strains, respectively. No child shed A\/H1N1 vaccine strain. There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV, as compared to the placebo groups, in all immunoassays for A\/H3N2 and B (log10 titer P &lt; .0001; GMT Ratio &gt;2.0). Among immunoassays for A\/H1N1, only the mucosal IgA GMT was significantly higher than placebo at day 21 (log10 titer P = .0465).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Children vaccinated with LAIV had serum and mucosal antibody responses to A\/H3N2 and B, but only a mucosal IgA response to A\/H1N1. Many children shed A\/H3N2 and B vaccine strains, but none shed A\/H1N1. More research is needed to determine the reason for decreased LAIV A\/H1N1 immunogenicity and virus shedding.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT01625689.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciy1003","type":"journal-article","created":{"date-parts":[[2018,11,23]],"date-time":"2018-11-23T15:10:34Z","timestamp":1542985834000},"page":"777-785","source":"Crossref","is-referenced-by-count":23,"title":["Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial Among Preschool-Aged Children in Urban Bangladesh"],"prefix":"10.1093","volume":"69","author":[{"given":"Kristen D C","family":"Lewis","sequence":"first","affiliation":[{"name":"Pharmaceutical Product Development, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3138-5965","authenticated-orcid":false,"given":"Justin R","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed Z","family":"Rahman","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min Z","family":"Levine","sequence":"additional","affiliation":[{"name":"Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larisa","family":"Rudenko","sequence":"additional","affiliation":[{"name":"Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter F","family":"Wright","sequence":"additional","affiliation":[{"name":"Dartmouth College, Hanover, New Hampshire"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline M","family":"Katz","sequence":"additional","affiliation":[{"name":"Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Len","family":"Dally","sequence":"additional","affiliation":[{"name":"The Emmes Corporation, Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6876-0191","authenticated-orcid":false,"given":"Mustafizur","family":"Rahman","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Isakova-Sivak","sequence":"additional","affiliation":[{"name":"Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalia A","family":"Ilyushina","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Matyushenko","sequence":"additional","affiliation":[{"name":"Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia M","family":"Fry","sequence":"additional","affiliation":[{"name":"Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen E","family":"Lindstrom","sequence":"additional","affiliation":[{"name":"Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph S","family":"Bresee","sequence":"additional","affiliation":[{"name":"Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W Abdullah","family":"Brooks","sequence":"additional","affiliation":[{"name":"International Health, Johns Hopkins University, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen M","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2018,11,27]]},"reference":[{"key":"2019081601551252100_CIT0001","doi-asserted-by":"crossref","first-page":"5734","DOI":"10.1016\/j.vaccine.2017.08.088","article-title":"Data and product needs for influenza immunization programs in low- and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation influenza vaccines","volume":"35","author":"Neuzil","year":"2017","journal-title":"Vaccine"},{"key":"2019081601551252100_CIT0002","unstructured":"World Health Organization. Preferred product characteristics for next-generation influenza vaccines. Available at: http:\/\/apps.who.int\/iris\/bitstream\/10665\/258767\/1\/9789241512466-eng.pdf. 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