title: Randomized, double-blinded clinical trial for human norovirus inactivation in oysters by high hydrostatic pressure processing.
abstract: Contamination of oysters with human noroviruses (HuNoV) constitutes a human health risk and may lead to severe economic losses in the shellfish industry. There is a need to identify a technology that can inactivate HuNoV in oysters. In this study, we conducted a randomized, double-blinded clinical trial to assess the effect of high hydrostatic pressure processing (HPP) on Norwalk virus (HuNoV genogroup I.1) inactivation in virus-seeded oysters ingested by subjects. Forty-four healthy, positive-secretor adults were divided into three study phases. Subjects in each phase were randomized into control and intervention groups. Subjects received Norwalk virus (8FIIb, 1.0 × 10(4) genomic equivalent copies) in artificially seeded oysters with or without HPP treatment (400 MPa at 25°C, 600 MPa at 6°C, or 400 MPa at 6°C for 5 min). HPP at 600 MPa, but not 400 MPa (at 6° or 25°C), completely inactivated HuNoV in seeded oysters and resulted in no HuNoV infection among these subjects, as determined by reverse transcription-PCR detection of HuNoV RNA in subjects' stool or vomitus samples. Interestingly, a white blood cell (granulocyte) shift was identified in 92% of the infected subjects and was significantly associated with infection (P = 0.0014). In summary, these data suggest that HPP is effective at inactivating HuNoV in contaminated whole oysters and suggest a potential intervention to inactivate infectious HuNoV in oysters for the commercial shellfish industry.
authors.affiliation: Hubert Department of Global Health, Rollins School of Public Health, Emory University, Room 6041 Claudia Nance Rollins Building, 1518 Clifton Rd. NE, Atlanta, GA 30322, USA.
authors.forename: Juan S
authors.initials: JS
authors.lastname: Leon
authors.forename: David H
authors.initials: DH
authors.lastname: Kingsley
authors.forename: Julia S
authors.initials: JS
authors.lastname: Montes
authors.forename: Gary P
authors.initials: GP
authors.lastname: Richards
authors.forename: G Marshall
authors.initials: GM
authors.lastname: Lyon
authors.forename: Gwen M
authors.initials: GM
authors.lastname: Abdulhafid
authors.forename: Scot R
authors.initials: SR
authors.lastname: Seitz
authors.forename: Marina L
authors.initials: ML
authors.lastname: Fernandez
authors.forename: Peter F
authors.initials: PF
authors.lastname: Teunis
authors.forename: George J
authors.initials: GJ
authors.lastname: Flick
authors.forename: Christine L
authors.initials: CL
authors.lastname: Moe
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D004311:Double-Blind Method; D005243:Feces / Q000821:virology; D005260:Female; D005511:Food Handling / Q000379:methods*; D019649:Food Industry; D005516:Food Microbiology; D006801:Humans; D006874:Hydrostatic Pressure; D008297:Male; D008875:Middle Aged; D029322:Norovirus / Q000302:isolation & purification* / Q000472:pathogenicity*; D010125:Ostreidae / Q000821:virology*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012758:Shellfish / Q000821:virology*