Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection
In this trial, the safety and efficacy of a recombinant chimpanzee adenovirus 3 vector priming vaccination and a recombinant modified vaccinia Ankara boost was assessed in adults who were at risk for HCV infection because of injection drug use. The vaccine did not cause serious adverse events and di...
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Veröffentlicht in: | The New England journal of medicine 2021-02, Vol.384 (6), p.541-549 |
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creator | Page, Kimberly Melia, Michael T Veenhuis, Rebecca T Winter, Matthew Rousseau, Kimberly E Massaccesi, Guido Osburn, William O Forman, Michael Thomas, Elaine Thornton, Karla Wagner, Katherine Vassilev, Ventzislav Lin, Lan Lum, Paula J Giudice, Linda C Stein, Ellen Asher, Alice Chang, Soju Gorman, Richard Ghany, Marc G Liang, T. Jake Wierzbicki, Michael R Scarselli, Elisa Nicosia, Alfredo Folgori, Antonella Capone, Stefania Cox, Andrea L |
description | In this trial, the safety and efficacy of a recombinant chimpanzee adenovirus 3 vector priming vaccination and a recombinant modified vaccinia Ankara boost was assessed in adults who were at risk for HCV infection because of injection drug use. The vaccine did not cause serious adverse events and did elicit HCV-specific T-cell responses, but it did not prevent chronic HCV infection. |
doi_str_mv | 10.1056/NEJMoa2023345 |
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Jake ; Wierzbicki, Michael R ; Scarselli, Elisa ; Nicosia, Alfredo ; Folgori, Antonella ; Capone, Stefania ; Cox, Andrea L</creator><creatorcontrib>Page, Kimberly ; Melia, Michael T ; Veenhuis, Rebecca T ; Winter, Matthew ; Rousseau, Kimberly E ; Massaccesi, Guido ; Osburn, William O ; Forman, Michael ; Thomas, Elaine ; Thornton, Karla ; Wagner, Katherine ; Vassilev, Ventzislav ; Lin, Lan ; Lum, Paula J ; Giudice, Linda C ; Stein, Ellen ; Asher, Alice ; Chang, Soju ; Gorman, Richard ; Ghany, Marc G ; Liang, T. Jake ; Wierzbicki, Michael R ; Scarselli, Elisa ; Nicosia, Alfredo ; Folgori, Antonella ; Capone, Stefania ; Cox, Andrea L</creatorcontrib><description>In this trial, the safety and efficacy of a recombinant chimpanzee adenovirus 3 vector priming vaccination and a recombinant modified vaccinia Ankara boost was assessed in adults who were at risk for HCV infection because of injection drug use. The vaccine did not cause serious adverse events and did elicit HCV-specific T-cell responses, but it did not prevent chronic HCV infection.</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa2023345</identifier><identifier>PMID: 33567193</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Adenoviruses, Simian - genetics ; Adolescent ; Adult ; Adverse events ; Allergies ; Animals ; Chronic infection ; Double-Blind Method ; Double-blind studies ; Enrollments ; Female ; Genetic Vectors ; Genotype & phenotype ; Hepatitis C ; Hepatitis C Antibodies - blood ; Hepatitis C, Chronic - epidemiology ; Hepatitis C, Chronic - immunology ; Hepatitis C, Chronic - prevention & control ; Humans ; Immunogenicity, Vaccine ; Incidence ; Infections ; Infectious diseases ; Laboratories ; Lymphocytes T ; Male ; Middle Aged ; Nonstructural proteins ; Pan troglodytes ; Peptides ; Placebos ; Ribonucleic acid ; RNA ; Substance Abuse, Intravenous ; T-Lymphocytes - immunology ; Vaccine efficacy ; Vaccines ; Vaccines, Synthetic - immunology ; Vaccinia ; Viral Hepatitis Vaccines - adverse effects ; Viral Hepatitis Vaccines - immunology ; Viral infections ; Viremia ; Young Adult</subject><ispartof>The New England journal of medicine, 2021-02, Vol.384 (6), p.541-549</ispartof><rights>Copyright © 2021 Massachusetts Medical Society. All rights reserved.</rights><rights>Copyright © 2021 Massachusetts Medical Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c511t-6e5052fd4d75fff5dd7ed17137cb3747bf3c6a3ffec249331c4463a2886ed55b3</citedby><cites>FETCH-LOGICAL-c511t-6e5052fd4d75fff5dd7ed17137cb3747bf3c6a3ffec249331c4463a2886ed55b3</cites><orcidid>0000-0003-3097-0289</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa2023345$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMoa2023345$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>230,314,776,780,881,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33567193$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Page, Kimberly</creatorcontrib><creatorcontrib>Melia, Michael T</creatorcontrib><creatorcontrib>Veenhuis, Rebecca T</creatorcontrib><creatorcontrib>Winter, Matthew</creatorcontrib><creatorcontrib>Rousseau, Kimberly E</creatorcontrib><creatorcontrib>Massaccesi, Guido</creatorcontrib><creatorcontrib>Osburn, William O</creatorcontrib><creatorcontrib>Forman, Michael</creatorcontrib><creatorcontrib>Thomas, Elaine</creatorcontrib><creatorcontrib>Thornton, Karla</creatorcontrib><creatorcontrib>Wagner, Katherine</creatorcontrib><creatorcontrib>Vassilev, Ventzislav</creatorcontrib><creatorcontrib>Lin, Lan</creatorcontrib><creatorcontrib>Lum, Paula J</creatorcontrib><creatorcontrib>Giudice, Linda C</creatorcontrib><creatorcontrib>Stein, Ellen</creatorcontrib><creatorcontrib>Asher, Alice</creatorcontrib><creatorcontrib>Chang, Soju</creatorcontrib><creatorcontrib>Gorman, Richard</creatorcontrib><creatorcontrib>Ghany, Marc G</creatorcontrib><creatorcontrib>Liang, T. Jake</creatorcontrib><creatorcontrib>Wierzbicki, Michael R</creatorcontrib><creatorcontrib>Scarselli, Elisa</creatorcontrib><creatorcontrib>Nicosia, Alfredo</creatorcontrib><creatorcontrib>Folgori, Antonella</creatorcontrib><creatorcontrib>Capone, Stefania</creatorcontrib><creatorcontrib>Cox, Andrea L</creatorcontrib><title>Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>In this trial, the safety and efficacy of a recombinant chimpanzee adenovirus 3 vector priming vaccination and a recombinant modified vaccinia Ankara boost was assessed in adults who were at risk for HCV infection because of injection drug use. The vaccine did not cause serious adverse events and did elicit HCV-specific T-cell responses, but it did not prevent chronic HCV infection.</description><subject>Adenoviruses, Simian - genetics</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Adverse events</subject><subject>Allergies</subject><subject>Animals</subject><subject>Chronic infection</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Enrollments</subject><subject>Female</subject><subject>Genetic Vectors</subject><subject>Genotype & phenotype</subject><subject>Hepatitis C</subject><subject>Hepatitis C Antibodies - blood</subject><subject>Hepatitis C, Chronic - epidemiology</subject><subject>Hepatitis C, Chronic - immunology</subject><subject>Hepatitis C, Chronic - prevention & control</subject><subject>Humans</subject><subject>Immunogenicity, Vaccine</subject><subject>Incidence</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Laboratories</subject><subject>Lymphocytes T</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nonstructural proteins</subject><subject>Pan troglodytes</subject><subject>Peptides</subject><subject>Placebos</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Substance Abuse, Intravenous</subject><subject>T-Lymphocytes - immunology</subject><subject>Vaccine efficacy</subject><subject>Vaccines</subject><subject>Vaccines, Synthetic - immunology</subject><subject>Vaccinia</subject><subject>Viral Hepatitis Vaccines - adverse effects</subject><subject>Viral Hepatitis Vaccines - immunology</subject><subject>Viral infections</subject><subject>Viremia</subject><subject>Young Adult</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kE1LAzEQhoMotlaPXiUgHleTnWSzvQhSWqvUD0S9hjQfNqWbaHZb0F_vSqvowbnMYR6eeXkROqTklBJenN0Or2-iykkOwPgW6lIOkDFGim3UJSQvMyb60EF7dT0n7VDW30UdAF4I2ocuGj2oYGLlP6zBj8mrBY4OK_ystPbB4gf74isbcBPxfbIrGxo8mKUYvMbjwTO-Cs7qxsewj3acWtT2YLN76Gk0fByMs8nd5dXgYpJpTmmTFZYTnjvDjODOOW6MsIYKCkJPQTAxdaALBa615qwPQDVjBai8LAtrOJ9CD52vva_LaWWNbgMltZCvyVcqvcuovPx7CX4mX-JKllAI0hp76HgjSPFtaetGzuMyhTazzFlZ5hSoYC2VrSmdYl0n634-UCK_apd_am_5o9-xfujvnlvgZA1UVS2DnVf_iD4BRTmI2Q</recordid><startdate>20210211</startdate><enddate>20210211</enddate><creator>Page, Kimberly</creator><creator>Melia, Michael T</creator><creator>Veenhuis, Rebecca T</creator><creator>Winter, Matthew</creator><creator>Rousseau, Kimberly E</creator><creator>Massaccesi, Guido</creator><creator>Osburn, William O</creator><creator>Forman, Michael</creator><creator>Thomas, Elaine</creator><creator>Thornton, Karla</creator><creator>Wagner, Katherine</creator><creator>Vassilev, Ventzislav</creator><creator>Lin, Lan</creator><creator>Lum, Paula J</creator><creator>Giudice, Linda C</creator><creator>Stein, Ellen</creator><creator>Asher, Alice</creator><creator>Chang, Soju</creator><creator>Gorman, Richard</creator><creator>Ghany, Marc G</creator><creator>Liang, T. 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subjects | Adenoviruses, Simian - genetics Adolescent Adult Adverse events Allergies Animals Chronic infection Double-Blind Method Double-blind studies Enrollments Female Genetic Vectors Genotype & phenotype Hepatitis C Hepatitis C Antibodies - blood Hepatitis C, Chronic - epidemiology Hepatitis C, Chronic - immunology Hepatitis C, Chronic - prevention & control Humans Immunogenicity, Vaccine Incidence Infections Infectious diseases Laboratories Lymphocytes T Male Middle Aged Nonstructural proteins Pan troglodytes Peptides Placebos Ribonucleic acid RNA Substance Abuse, Intravenous T-Lymphocytes - immunology Vaccine efficacy Vaccines Vaccines, Synthetic - immunology Vaccinia Viral Hepatitis Vaccines - adverse effects Viral Hepatitis Vaccines - immunology Viral infections Viremia Young Adult |
title | Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection |
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