Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

Summary

The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine.

Timeline

Start

2015-02-26

Primary completion

2015-04-07

Completion

2015-09-09

Publications

• Atmar RL, Ettayebi K, Neill FH, Braun RP, Sherwood J, Ramani S, Estes MK. Correlation of Genogroup I, Genotype 1 (GI.1) Norovirus Neutralizing Antibody Levels With GI.1 Histo-Blood Group Antigen-Blocking Antibody Levels. J Infect Dis. 2024 Dec 16;230(6):1376-1379. doi: 10.1093/infdis/jiae311.
• Atmar RL, Ettayebi K, Ayyar BV, Neill FH, Braun RP, Ramani S, Estes MK. Comparison of Microneutralization and Histo-Blood Group Antigen-Blocking Assays for Functional Norovirus Antibody Detection. J Infect Dis. 2020 Feb 18;221(5):739-743. doi: 10.1093/infdis/jiz526.
• Atmar RL, Cramer JP, Baehner F, Han C, Borkowski A, Mendelman PM. An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults. J Infect Dis. 2019 Jan 9;219(3):410-414. doi: 10.1093/infdis/jiy529.

Drugs

Indications