Broad Blockade Antibody Responses in Human Volunteers after Immunization with a Multivalent Norovirus VLP Candidate Vaccine: Immunological Analyses from a Phase I Clinical Trial

PLoS Medicine - Tập 12 Số 3 - Trang e1001807
Lisa C. Lindesmith1, Martin T. Ferris2, Clancy W. Mullan2, Jennifer Ferreira3, Kari Debbink1, Jesica Swanstrom1, Charles C. Richardson4, Robert R. Goodwin4, Frank Baehner5, Paul M. Mendelman4, Robert F. Bargatze4, Ralph S. Baric1
1Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, United States of America.
2Department of Genetics, University of North Carolina, Chapel Hill, North Carolina, United States of America
3The EMMES Corporation, Rockville, Maryland, United States of America.
4Takeda Vaccines, Deerfield, Illinois, United States of America.
5Takeda Pharmaceutical International, Zurich, Switzerland.

Tóm tắt

Từ khóa


Tài liệu tham khảo

2013

2011, Updated norovirus outbreak management and disease prevention guidelines, MMWR Recomm Rep, 60, 1

TK Trivedi, 2013, Clinical characteristics of norovirus-associated deaths: a systematic literature review, Am J Infect Control, 41, 654, 10.1016/j.ajic.2012.08.002

K Bok, 2012, Norovirus gastroenteritis in immunocompromised patients, N Engl J Med, 367, 2126, 10.1056/NEJMra1207742

TK Trivedi, 2012, Hospitalizations and mortality associated with norovirus outbreaks in nursing homes, 2009–2010, JAMA, 308, 1668, 10.1001/jama.2012.14023

AM Hutson, 2004, Norovirus disease: changing epidemiology and host susceptibility factors, Trends Microbiol, 12, 279, 10.1016/j.tim.2004.04.005

MK Estes, 2006, Noroviruses everywhere: has something changed?, Curr Opin Infect Dis, 19, 467, 10.1097/01.qco.0000244053.69253.3d

M Koopmans, 2000, Molecular epidemiology of human enteric caliciviruses in The Netherlands, J Infect Dis, 181, S262, 10.1086/315573

2007, Norovirus activity—United States, 2006–2007, MMWR Morb Mortal Wekly Rep, 56, 842

M Okada, 2006, Genetic analysis of noroviruses associated with fatalities in healthcare facilities, Arch Virol, 151, 1635, 10.1007/s00705-006-0739-6

JP Harris, 2008, Deaths from norovirus among the elderly, England and Wales, Emerg Infect Dis, 14, 1546, 10.3201/eid1410.080188

R Schorn, 2010, Chronic norovirus infection after kidney transplantation: molecular evidence for immune-driven viral evolution, Clin Infect Dis, 51, 307, 10.1086/653939

AJ Hall, 2012, Epidemiology of foodborne norovirus outbreaks, United States, 2001–2008, Emerg Infect Dis, 18, 1566, 10.3201/eid1810.120833

A Kroneman, 2008, Data quality of 5 years of central norovirus outbreak reporting in the European Network for food-borne viruses, J Public Health (Oxf), 30, 82, 10.1093/pubmed/fdm080

DP Zheng, 2006, Norovirus classification and proposed strain nomenclature, Virology, 346, 312, 10.1016/j.virol.2005.11.015

KY Green, 1993, Comparison of the reactivities of baculovirus-expressed recombinant Norwalk virus capsid antigen with those of the native Norwalk virus antigen in serologic assays and some epidemiologic observations, J Clin Microbiol, 31, 2185, 10.1128/JCM.31.8.2185-2191.1993

BV Prasad, 1999, X-ray crystallographic structure of the Norwalk virus capsid, Science, 286, 287, 10.1126/science.286.5438.287

L Lindesmith, 2003, Human susceptibility and resistance to Norwalk virus infection, Nat Med, 9, 548, 10.1038/nm860

LC Lindesmith, 2008, Mechanisms of GII.4 norovirus persistence in human populations, PLoS Med, 5, e0050031, 10.1371/journal.pmed.0050031

LC Lindesmith, 2013, Emergence of a norovirus GII.4 strain correlates with changes in evolving blockade epitopes, J Virol, 87, 2803, 10.1128/JVI.03106-12

K Bok, 2011, Chimpanzees as an animal model for human norovirus infection and vaccine development, Proc Natl Acad Sci U S A, 108, 325, 10.1073/pnas.1014577107

A Reeck, 2010, Serological correlate of protection against norovirus-induced gastroenteritis, J Infect Dis, 202, 1212, 10.1086/656364

RL Atmar, 2011, Norovirus vaccine against experimental human Norwalk Virus illness, N Engl J Med, 365, 2178, 10.1056/NEJMoa1101245

JJ Siebenga, 2007, Epochal evolution of GGII.4 norovirus capsid proteins from 1995 to 2006, J Virol, 81, 9932, 10.1128/JVI.00674-07

LC Lindesmith, 2012, Immunogenetic mechanisms driving norovirus GII.4 antigenic variation, PLoS Pathog, 8, e1002705, 10.1371/journal.ppat.1002705

LC Lindesmith, 2011, Norovirus GII.4 strain antigenic variation, J Virol, 85, 231, 10.1128/JVI.01364-10

K Debbink, 2012, Genetic mapping of a highly variable norovirus GII.4 blockade epitope: potential role in escape from human herd immunity, J Virol, 86, 1214, 10.1128/JVI.06189-11

JL Cannon, 2009, Herd immunity to GII.4 noroviruses is supported by outbreak patient sera, J Virol, 83, 5363, 10.1128/JVI.02518-08

K Debbink, 2013, Emergence of new pandemic GII.4 Sydney norovirus strain correlates with escape from herd immunity, J Infect Dis, 208, 1877, 10.1093/infdis/jit370

EF Donaldson, 2008, Norovirus pathogenesis: mechanisms of persistence and immune evasion in human populations, Immunol Rev, 225, 190, 10.1111/j.1600-065X.2008.00680.x

LC Lindesmith, 2012, Monoclonal antibody-based antigenic mapping of norovirus GII.4-2002, J Virol, 86, 873, 10.1128/JVI.06200-11

LC Lindesmith, 2014, Particle conformation regulates antibody access to a conserved GII.4 norovirus blockade epitope, J Virol, 88, 8826, 10.1128/JVI.01192-14

JS Eden, 2013, Recombination within the pandemic norovirus GII.4 lineage, J Virol, 87, 6270, 10.1128/JVI.03464-12

RA Bull, 2010, Rapid evolution of pandemic noroviruses of the GII.4 lineage, PLoS Pathog, 6, e1000831, 10.1371/journal.ppat.1000831

JJ Siebenga, 2010, Phylodynamic reconstruction reveals norovirus GII.4 epidemic expansions and their molecular determinants, PLoS Pathog, 6, e1000884, 10.1371/journal.ppat.1000884

C Richardson, 2013, Norovirus virus-like particle vaccines for the prevention of acute gastroenteritis, Expert Rev Vaccines, 12, 155, 10.1586/erv.12.145

JJ Treanor, 2014, A novel intramuscular bivalent norovirus virus-like particle vaccine candidate-reactogenicity, safety, and immunogenicity in a phase 1 trial in healthy adults, J Infect Dis, 210, 1763, 10.1093/infdis/jiu337

EF Donaldson, 2010, Viral shape-shifting: norovirus evasion of the human immune system, Nat Rev Microbiol, 8, 231, 10.1038/nrmicro2296

J Nordgren, 2010, Norovirus gastroenteritis outbreak with a secretor-independent susceptibility pattern, Sweden, Emerg Infect Dis, 16, 81, 10.3201/eid1601.090633

R Frenck, 2012, Predicting susceptibility to norovirus GII.4 by use of a challenge model involving humans, J Infect Dis, 206, 1386, 10.1093/infdis/jis514

L Lindesmith, 2005, Cellular and humoral immunity following Snow Mountain virus challenge, J Virol, 79, 2900, 10.1128/JVI.79.5.2900-2909.2005

Bernstein DI, Atmar RL, Lyon GM, Treanor JJ, Chen WH, et al. (2014) Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults. J Infect Dis. E-pub ahead of print. <comment>doi: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://dx.doi.org/10.1093/infdis/jiu497" xlink:type="simple">10.1093/infdis/jiu497</ext-link></comment>

J Swanstrom, 2014, Characterization of blockade antibody responses in GII.2.1976 Snow Mountain virus-infected subjects, J Virol, 88, 829, 10.1128/JVI.02793-13

AD LoBue, 2006, Multivalent norovirus vaccines induce strong mucosal and systemic blocking antibodies against multiple strains, Vaccine, 24, 5220, 10.1016/j.vaccine.2006.03.080

K Debbink, 2014, Within-host evolution results in antigenically distinct GII.4 noroviruses, J Virol, 88, 7244, 10.1128/JVI.00203-14

Z Cai, 2010, A computational framework for influenza antigenic cartography, PLoS Comput Biol, 6, e1000949, 10.1371/journal.pcbi.1000949

F Wang, 2013, Somatic hypermutation maintains antibody thermodynamic stability during affinity maturation, Proc Natl Acad Sci U S A, 110, 4261, 10.1073/pnas.1301810110

D Hoffmann, 2012, Norovirus GII.4 and GII.7 capsid sequences undergo positive selection in chronically infected patients, Infect Genet Evol, 12, 461, 10.1016/j.meegid.2012.01.020

JL Barnett, 2012, AntigenMap 3D: an online antigenic cartography resource, Bioinformatics, 28, 1292, 10.1093/bioinformatics/bts105

K Debbink, 2012, Norovirus immunity and the great escape, PLoS Pathog, 8, e1002921, 10.1371/journal.ppat.1002921

LC Lindesmith, 2010, Heterotypic humoral and cellular immune responses following Norwalk virus infection, J Virol, 84, 1800, 10.1128/JVI.02179-09

AG Schmidt, 2013, Preconfiguration of the antigen-binding site during affinity maturation of a broadly neutralizing influenza virus antibody, Proc Natl Acad Sci U S A, 110, 264, 10.1073/pnas.1218256109

GM Li, 2012, Pandemic H1N1 influenza vaccine induces a recall response in humans that favors broadly cross-reactive memory B cells, Proc Natl Acad Sci U S A, 109, 9047, 10.1073/pnas.1118979109

M Kobayashi, 2012, Immunogenicity and reactogenicity of a monovalent inactivated 2009 influenza A vaccine in adolescents: with special reference to pre-existing antibody, J Pediatr, 160, 632, 10.1016/j.jpeds.2011.09.055

MC Knuchel, 2013, Relevance of a pre-existing measles immunity prior immunization with a recombinant measles virus vector, Hum Vaccin Immunother, 9, 599, 10.4161/hv.23241

XF Liang, 2010, Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial, Lancet, 375, 56, 10.1016/S0140-6736(09)62003-1

FC Zhu, 2009, A novel influenza A (H1N1) vaccine in various age groups, N Engl J Med, 361, 2414, 10.1056/NEJMoa0908535

J Wrammert, 2008, Rapid cloning of high-affinity human monoclonal antibodies against influenza virus, Nature, 453, 667, 10.1038/nature06890

JR Mora, 2008, Homing imprinting and immunomodulation in the gut: role of dendritic cells and retinoids, Inflamm Bowel Dis, 14, 275, 10.1002/ibd.20280

NA Kuklin, 2001, Protective intestinal anti-rotavirus B cell immunity is dependent on alpha 4 beta 7 integrin expression but does not require IgA antibody production, J Immunol, 166, 1894, 10.4049/jimmunol.166.3.1894

DJ Smith, 2004, Mapping the antigenic and genetic evolution of influenza virus, Science, 305, 371, 10.1126/science.1097211

SW Huang, 2009, Reemergence of enterovirus 71 in 2008 in taiwan: dynamics of genetic and antigenic evolution from 1998 to 2008, J Clin Microbiol, 47, 3653, 10.1128/JCM.00630-09

K Debbink, 2014, Chimeric GII.4 norovirus virus-like-particle-based vaccines induce broadly blocking immune responses, J Virol, 88, 7256, 10.1128/JVI.00785-14

D Corti, 2010, Heterosubtypic neutralizing antibodies are produced by individuals immunized with a seasonal influenza vaccine, J Clin Invest, 120, 1663, 10.1172/JCI41902

J Lessler, 2012, Evidence for antigenic seniority in influenza A (H3N2) antibody responses in southern China, PLoS Pathog, 8, e1002802, 10.1371/journal.ppat.1002802