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Bioconjugation technology, exploited here for an\n                    <jats:named-content content-type=\"genus-species\">Shigella flexneri<\/jats:named-content>\n                    2a candidate vaccine, offers a novel and potentially cost-effective way to develop and produce vaccines against a major pathogen of global health importance. Flexyn2a, a novel\n                    <jats:named-content content-type=\"genus-species\">S. flexneri<\/jats:named-content>\n                    2a bioconjugate vaccine made of the polysaccharide component of the\n                    <jats:named-content content-type=\"genus-species\">S. flexneri<\/jats:named-content>\n                    2a O-antigen, conjugated to the exotoxin protein A of\n                    <jats:named-content content-type=\"genus-species\">Pseudomonas aeruginosa<\/jats:named-content>\n                    (EPA), was evaluated for safety and immunogenicity among healthy adults in a single-blind, phase I study with a staggered randomization approach. Thirty subjects (12 receiving 10 \u03bcg Flexyn2a, 12 receiving Flexyn2a with aluminum adjuvant, and 6 receiving placebo) were administered two injections 4 weeks apart and were followed for 168 days. Flexyn2a was well-tolerated, independently of the adjuvant and number of injections. The Flexyn2a vaccine elicited statistically significant\n                    <jats:named-content content-type=\"genus-species\">S. flexneri<\/jats:named-content>\n                    2a lipopolysaccharide (LPS)-specific humoral responses at all time points postimmunization in all groups that received the vaccine. Elicited serum antibodies were functional, as evidenced by bactericidal activity against\n                    <jats:named-content content-type=\"genus-species\">S. flexneri<\/jats:named-content>\n                    2a. The bioconjugate candidate vaccine Flexyn2a has a satisfactory safety profile and elicited a robust humoral response to\n                    <jats:named-content content-type=\"genus-species\">S. flexneri<\/jats:named-content>\n                    2a LPS with or without inclusion of an adjuvant. Moreover, the bioconjugate also induced functional antibodies, showing the technology's features in producing a promising candidate vaccine. (This study has been registered at ClinicalTrials.gov under registration no. NCT02388009.)\n                  <\/jats:p>","DOI":"10.1128\/cvi.00224-16","type":"journal-article","created":{"date-parts":[[2016,8,31]],"date-time":"2016-08-31T20:22:21Z","timestamp":1472674941000},"page":"908-917","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":140,"title":["Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study"],"prefix":"10.1128","volume":"23","author":[{"given":"Mark S.","family":"Riddle","sequence":"first","affiliation":[{"name":"Naval Medical Research Center, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert W.","family":"Kaminski","sequence":"additional","affiliation":[{"name":"Walter Reed Army Institute of Research, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Di Paolo","sequence":"additional","affiliation":[{"name":"LimmaTech Biologics, Schlieren, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chad K.","family":"Porter","sequence":"additional","affiliation":[{"name":"Naval Medical Research Center, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramiro L.","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Naval Medical Research Center, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen A.","family":"Clarkson","sequence":"additional","affiliation":[{"name":"Walter Reed Army Institute of Research, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hailey E.","family":"Weerts","sequence":"additional","affiliation":[{"name":"Walter Reed Army Institute of Research, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Duplessis","sequence":"additional","affiliation":[{"name":"Naval Medical Research Center, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Castellano","sequence":"additional","affiliation":[{"name":"Walter Reed Army Institute of Research, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Alaimo","sequence":"additional","affiliation":[{"name":"LimmaTech Biologics, Schlieren, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristopher","family":"Paolino","sequence":"additional","affiliation":[{"name":"Walter Reed Army Institute of Research, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Gormley","sequence":"additional","affiliation":[{"name":"Naval Medical Research Center, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronica","family":"Gambillara Fonck","sequence":"additional","affiliation":[{"name":"LimmaTech Biologics, Schlieren, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61728-0"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2006.74.891"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2009.80.609"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60844-2"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(15)00151-5"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268814003446"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1207777"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2015.1011578"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu468"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02713-12"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31529-X"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2014.11.049"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/QCO.0000000000000096"},{"key":"e_1_3_3_15_2","first-page":"88","article-title":"New developments in traveler's diarrhea","volume":"7","author":"de la Cabada Bauche J","year":"2011","unstructured":"de la Cabada Bauche J, Dupont HL. 2011. 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