Correlation of Genogroup I, Genotype 1 (GI.1) Norovirus Neutralizing Antibody Levels With GI.1 Histo-Blood Group Antigen–Blocking Antibody Levels

Author:

Atmar Robert L12ORCID,Ettayebi Khalil2ORCID,Neill Frederick H2,Braun Ralph P3,Sherwood James4,Ramani Sasirekha2ORCID,Estes Mary K12ORCID

Affiliation:

1. Department of Medicine, Baylor College of Medicine , Houston, Texas , USA

2. Department of Molecular Virology & Microbiology, Baylor College of Medicine , Houston, Texas , USA

3. Icosavax , Seattle, Washington , USA

4. Takeda Pharmaceuticals International , Zurich , Switzerland (former affiliation)

Abstract

Abstract 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

Funder

Takeda Vaccines Business Unit

Publisher

Oxford University Press (OUP)

Reference15 articles.

1. Serological correlate of protection against norovirus-induced gastroenteritis;Reeck;J Infect Dis,2010

2. Norovirus vaccine against experimental human Norwalk virus illness;Atmar;N Engl J Med,2011

3. High serum levels of norovirus genotype-specific blocking antibodies correlate with protection from infection in children;Malm;J Infect Dis,2014

4. Serological correlates of protection against a GII.4 norovirus;Atmar;Clin Vaccine Immunol,2015

5. Comparison of microneutralization and histo-blood group antigen-blocking assays for functional norovirus antibody detection;Atmar;J Infect Dis,2020

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