The Journal of infectious diseases · 2024
Correlation of Genogroup I, Genotype 1 (GI.1) Norovirus Neutralizing Antibody Levels With GI.1 Histo-Blood Group Antigen-Blocking Antibody Levels.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
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Atmar Robert L, Ettayebi Khalil, Neill Frederick H, Braun Ralph P, Sherwood James, Ramani Sasirekha, Estes Mary K
Аннотация
BACKGROUND: The in vitro cultivation of human noroviruses allows a comparison of antibody levels measured in neutralization and histo-blood group antigen (HBGA)-blocking assays.
METHODS: Serum samples collected during the evaluation of an investigational norovirus vaccine (HIL-214 [formerly TAK-214]) were assayed for neutralizing antibody levels against the vaccine's prototype Norwalk virus/genogroup I, genotype 1 (GI.1) (P1) virus strain. Results were compared with those previously determined using HBGA-blocking assays.
RESULTS: Neutralizing antibody seroresponses were observed in 83% of 24 vaccinated adults, and antibody levels were highly correlated (r = 0.81; P < .001) with those measured by HBGA blocking.
CONCLUSIONS: Genogroup I, genotype 1 (GI.1)-specific HBGA-blocking antibodies are a surrogate for neutralization of GI.1 norovirus. Clinical Trials Registration. Clinicaltrials.gov NCT02475278.
METHODS: Serum samples collected during the evaluation of an investigational norovirus vaccine (HIL-214 [formerly TAK-214]) were assayed for neutralizing antibody levels against the vaccine's prototype Norwalk virus/genogroup I, genotype 1 (GI.1) (P1) virus strain. Results were compared with those previously determined using HBGA-blocking assays.
RESULTS: Neutralizing antibody seroresponses were observed in 83% of 24 vaccinated adults, and antibody levels were highly correlated (r = 0.81; P < .001) with those measured by HBGA blocking.
CONCLUSIONS: Genogroup I, genotype 1 (GI.1)-specific HBGA-blocking antibodies are a surrogate for neutralization of GI.1 norovirus. Clinical Trials Registration. Clinicaltrials.gov NCT02475278.