Adjuvanted Intranasal Norwalk Virus-Like Particle Vaccine Elicits Antibodies and Antibody-Secreting Cells That Express Homing Receptors for Mucosal and Peripheral Lymphoid Tissues
Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods.We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A...
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| Published in | The Journal of infectious diseases Vol. 202; no. 11; pp. 1649 - 1658 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford
The University of Chicago Press
01.12.2010
University of Chicago Press Oxford University Press |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods.We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18–49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50-and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. Results. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8-and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50-or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. Conclusions. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Trial Registration. ClinicalTrials.gov identifier: NCT00806962. |
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| AbstractList | Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide.BACKGROUNDNoroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide.We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50- and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors.METHODSWe conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50- and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors.The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50- or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues.RESULTSThe most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50- or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues.The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study.CONCLUSIONSThe intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50- and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. Results. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50- or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. Conclusions. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Trial Registration. ClinicalTrials.gov identifier: NCT00806962. Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50-and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. Results. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8-and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50-or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. Conclusions. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Trial Registration. ClinicalTrials.gov identifier: NCT00806962. Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-[mu]g dosages of Norwalk antigen, and study 2 evaluated 50- and 100-[mu]g dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. Results. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-[mu]g dosage level. All subjects tested who received the 50- or 100-[mu]g vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. Conclusions. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50- and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50- or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Background . Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18–49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50-and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. Results. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8-and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50-or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. Conclusions. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Trial Registration. ClinicalTrials.gov identifier: NCT00806962. |
| Author | Sztein, Marcelo B. Tacket, Carol O. Ferreira, Jennifer Mendelman, Paul M. El-Kamary, Samer S. Richardson, Charles Bernstein, David I. Bargatze, Robert F. Frey, Sharon E. Chen, Wilbur H. Treanor, John J. Pasetti, Marcela F. Sublett, Richard |
| Author_xml | – sequence: 1 givenname: Samer S. surname: El-Kamary fullname: El-Kamary, Samer S. email: selkamar@epi.umaryland.edu organization: Department of Epidemiology and Public Health – sequence: 2 givenname: Marcela F. surname: Pasetti fullname: Pasetti, Marcela F. organization: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore – sequence: 3 givenname: Paul M. surname: Mendelman fullname: Mendelman, Paul M. organization: LigoCyte Pharmaceuticals, Inc, Bozeman, Montana – sequence: 4 givenname: Sharon E. surname: Frey fullname: Frey, Sharon E. organization: Saint Louis University School of Medicine, St Louis, Missouri – sequence: 5 givenname: David I. surname: Bernstein fullname: Bernstein, David I. organization: Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio – sequence: 6 givenname: John J. surname: Treanor fullname: Treanor, John J. organization: University of Rochester Medical Center, Rochester, New York – sequence: 7 givenname: Jennifer surname: Ferreira fullname: Ferreira, Jennifer organization: University of Rochester Medical Center, Rochester, New York – sequence: 8 givenname: Wilbur H. surname: Chen fullname: Chen, Wilbur H. organization: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore – sequence: 9 givenname: Richard surname: Sublett fullname: Sublett, Richard organization: LigoCyte Pharmaceuticals, Inc, Bozeman, Montana – sequence: 10 givenname: Charles surname: Richardson fullname: Richardson, Charles organization: LigoCyte Pharmaceuticals, Inc, Bozeman, Montana – sequence: 11 givenname: Robert F. surname: Bargatze fullname: Bargatze, Robert F. organization: LigoCyte Pharmaceuticals, Inc, Bozeman, Montana – sequence: 12 givenname: Marcelo B. surname: Sztein fullname: Sztein, Marcelo B. organization: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore – sequence: 13 givenname: Carol O. surname: Tacket fullname: Tacket, Carol O. organization: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23436199$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20979455$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2010 Infectious Diseases Society of America 2010 by the Infectious Diseases Society of America 2010 2015 INIST-CNRS |
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| Issue | 11 |
| Keywords | Virus Infection Calicivirus Antibody Norwalk like virus Caliciviridae Immunological adjuvant Mucosa Virus like particle Vaccine Intranasal administration Lymphoid tissue |
| Language | English |
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| Notes | ark:/67375/HXZ-RZNG1388-L S.S.E.-K. and M.F.P. contributed equally to this work. istex:E5EE03A60141036F1300350AA942ABD32123F0D7 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
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| PublicationTitle | The Journal of infectious diseases |
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| PublicationYear | 2010 |
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| References | J Infect Dis. 2011 Apr 1;203(7):1036 20979457 - J Infect Dis. 2010 Dec 1;202(11):1623-5 |
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| Snippet | Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods.We conducted 2 phase 1... Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1... Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1... Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. We conducted 2 phase 1 double-blind, controlled... Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide.BACKGROUNDNoroviruses cause significant morbidity... Background . Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods. We conducted 2 phase 1... |
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| SubjectTerms | Adjuvants, Immunologic - administration & dosage Administration, Intranasal Adolescent Adult Antibodies Antibodies, Viral - biosynthesis Antibodies, Viral - blood Antibody-Producing Cells - immunology Antibody-Producing Cells - metabolism Antigens Applied microbiology Biological and medical sciences Caliciviridae Infections - prevention & control Caliciviridae Infections - virology Chitosan - administration & dosage Chitosan - immunology Dosage Double-Blind Method Fundamental and applied biological sciences. Psychology Gastroenteritis - prevention & control Gastroenteritis - virology Geometric mean Hemagglutination Inhibition Tests Homing Humans Immunoglobulins Infectious diseases Integrins Lipid A - administration & dosage Lipid A - analogs & derivatives Lipid A - immunology Lymphoid Tissue - metabolism Lymphoid Tissue - virology Major and Brief Reports Medical sciences Microbiology Middle Aged Miscellaneous Mucous Membrane - metabolism Mucous Membrane - virology Norovirus Norwalk virus Norwalk virus - immunology Receptors, Lymphocyte Homing - metabolism Vaccination Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Viral Vaccines - administration & dosage Viral Vaccines - adverse effects Viral Vaccines - immunology Viral Vaccines - standards Virology Viruses Young Adult |
| Title | Adjuvanted Intranasal Norwalk Virus-Like Particle Vaccine Elicits Antibodies and Antibody-Secreting Cells That Express Homing Receptors for Mucosal and Peripheral Lymphoid Tissues |
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