Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults
Background: Major global economic and health burdens due to norovirus gastroenteritis could be addressed by an effective vaccine. Methods: In this study, 428 adult recipients of various compositions of the norovirus vaccine candidate, HIL-214, were followed for 5 years, to assess immune responses to...
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MDPI AG
2025-01-01
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| author | Geert Leroux-Roels Robert L. Atmar Jakob P. Cramer Ian Escudero Astrid Borkowski |
| author_facet | Geert Leroux-Roels Robert L. Atmar Jakob P. Cramer Ian Escudero Astrid Borkowski |
| author_sort | Geert Leroux-Roels |
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| description | Background: Major global economic and health burdens due to norovirus gastroenteritis could be addressed by an effective vaccine. Methods: In this study, 428 adult recipients of various compositions of the norovirus vaccine candidate, HIL-214, were followed for 5 years, to assess immune responses to its virus-like particle antigens, GI.1 and GII.4c. Serum antibodies and peripheral-blood antibody-secreting cells (ASCs) were measured. This report focuses on the single-dose 15/50 (µg GI.1/GII.4c) composition, which had been selected for further clinical development. Results: For single-dose 15/50 recipients (N = 105), GI.1-specific and GII.4c-specific histoblood-group antigen-blocking (HBGA) antibodies appeared to have persisted to 5 years, waning from a peak at 4 to 8 weeks, and plateauing above baseline after 3 years. From 3 to 5 years, GI.1-specific GMTs ranged between 53 (95%CI, 40–71) and 60 (95%CI, 46–77; N = 69–97) and were approximately 2-fold above the baseline GMT (24 (95%CI, 20–28); N = 105). GII.4c-specific GMTs ranged between 103 (95%CI, 77–138) and 114 (95%CI, 86–152; N = 70–97) and were above baseline, but by less than 2-fold (70 (95%CI, 53–92); N = 105). Similar kinetics were observed for pan-Ig titers and ASCs in a subset. Similar kinetics were also observed for HBGA and pan-Ig titers in recipients of other 15/50 dosages. Conclusions: Immune responses to HIL-214 in adults appear to persist for five years. |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-7cc20c4d60d74bc7b29be701d32a01702025-01-24T13:51:53ZengMDPI AGVaccines2076-393X2025-01-011318210.3390/vaccines13010082Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in AdultsGeert Leroux-Roels0Robert L. Atmar1Jakob P. Cramer2Ian Escudero3Astrid Borkowski4Center for Vaccinology (CEVAC), Ghent University and University Hospital, 9000 Ghent, BelgiumDepartments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX 77030, USAClinical Development, Takeda Pharmaceuticals International AG, Farman Strasse 11, Opfikon, 8152 Zurich, SwitzerlandClinical Development, Takeda Pharmaceuticals International AG, Farman Strasse 11, Opfikon, 8152 Zurich, SwitzerlandClinical Development, Takeda Pharmaceuticals International AG, Farman Strasse 11, Opfikon, 8152 Zurich, SwitzerlandBackground: Major global economic and health burdens due to norovirus gastroenteritis could be addressed by an effective vaccine. Methods: In this study, 428 adult recipients of various compositions of the norovirus vaccine candidate, HIL-214, were followed for 5 years, to assess immune responses to its virus-like particle antigens, GI.1 and GII.4c. Serum antibodies and peripheral-blood antibody-secreting cells (ASCs) were measured. This report focuses on the single-dose 15/50 (µg GI.1/GII.4c) composition, which had been selected for further clinical development. Results: For single-dose 15/50 recipients (N = 105), GI.1-specific and GII.4c-specific histoblood-group antigen-blocking (HBGA) antibodies appeared to have persisted to 5 years, waning from a peak at 4 to 8 weeks, and plateauing above baseline after 3 years. From 3 to 5 years, GI.1-specific GMTs ranged between 53 (95%CI, 40–71) and 60 (95%CI, 46–77; N = 69–97) and were approximately 2-fold above the baseline GMT (24 (95%CI, 20–28); N = 105). GII.4c-specific GMTs ranged between 103 (95%CI, 77–138) and 114 (95%CI, 86–152; N = 70–97) and were above baseline, but by less than 2-fold (70 (95%CI, 53–92); N = 105). Similar kinetics were observed for pan-Ig titers and ASCs in a subset. Similar kinetics were also observed for HBGA and pan-Ig titers in recipients of other 15/50 dosages. Conclusions: Immune responses to HIL-214 in adults appear to persist for five years.https://www.mdpi.com/2076-393X/13/1/82norovirusvaccinestomach flugastroenteritisvirus-like particleimmunogenicity |
| spellingShingle | Geert Leroux-Roels Robert L. Atmar Jakob P. Cramer Ian Escudero Astrid Borkowski Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults Vaccines norovirus vaccine stomach flu gastroenteritis virus-like particle immunogenicity |
| title | Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults |
| title_full | Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults |
| title_fullStr | Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults |
| title_full_unstemmed | Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults |
| title_short | Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults |
| title_sort | persistence of the immune response to an intramuscular bivalent gi 1 gii 4 norovirus vaccine in adults |
| topic | norovirus vaccine stomach flu gastroenteritis virus-like particle immunogenicity |
| url | https://www.mdpi.com/2076-393X/13/1/82 |
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