Lack of immunogenicity of ice structuring protein type III HPLC12 preparation administered by the oral route to human volunteers

TY - JOUR

T1 - Lack of immunogenicity of ice structuring protein type III HPLC12 preparation administered by the oral route to human volunteers

AU - Crevel, R W R

AU - Cooper, K J

AU - Poulsen, Lars K.

AU - Hummelshoj, L

AU - Bindslev-Jensen, Carsten

AU - Burks, A W

AU - Sampson, H A

PY - 2007

Y1 - 2007

N2 - Before a novel protein can be used in foods, its potential allergenicity must be assessed. In this study, healthy volunteers consumed ice structuring protein (ISP) Type III preparation or a control material 5 days a week for a total of 8 weeks. General measures of health were recorded during the study, and the immunogenicity of the protein was assessed by monitoring the levels of IgG and IgE antibodies specific for ISP Type III. The participants remained in good health throughout the study and during the 4 week follow-up period. No IgG or IgE antibodies specific for ISP Type III were detected in the blood of the participants. Investigations of immunogenicity in man have not been previously applied in the context of safety evaluation and they do not form part of the regimens proposed for the evaluation of protein allergenicity. Consequently no standardised protocols exist for such studies, nor any background against which to interpret the results. Nevertheless, the absence of an immune response using a protocol which could have been expected to result in a response with a strongly immunogenic protein, confirms the conclusions of earlier published work, and attests to the lack of allergenicity of ISP Type III preparation.

AB - Before a novel protein can be used in foods, its potential allergenicity must be assessed. In this study, healthy volunteers consumed ice structuring protein (ISP) Type III preparation or a control material 5 days a week for a total of 8 weeks. General measures of health were recorded during the study, and the immunogenicity of the protein was assessed by monitoring the levels of IgG and IgE antibodies specific for ISP Type III. The participants remained in good health throughout the study and during the 4 week follow-up period. No IgG or IgE antibodies specific for ISP Type III were detected in the blood of the participants. Investigations of immunogenicity in man have not been previously applied in the context of safety evaluation and they do not form part of the regimens proposed for the evaluation of protein allergenicity. Consequently no standardised protocols exist for such studies, nor any background against which to interpret the results. Nevertheless, the absence of an immune response using a protocol which could have been expected to result in a response with a strongly immunogenic protein, confirms the conclusions of earlier published work, and attests to the lack of allergenicity of ISP Type III preparation.

KW - Adjuvants, Immunologic

KW - Administration, Oral

KW - Adult

KW - Allergens

KW - Antifreeze Proteins, Type III

KW - Basophils

KW - Dietary Proteins

KW - Electrophoresis, Polyacrylamide Gel

KW - Enzyme-Linked Immunosorbent Assay

KW - Female

KW - Food Hypersensitivity

KW - Histamine

KW - Humans

KW - Immunoblotting

KW - Immunoglobulin E

KW - Immunoglobulin G

KW - Male

KW - Middle Aged

KW - Random Allocation

KW - Single-Blind Method

KW - Skin Tests

KW - Toxicity Tests

U2 - 10.1016/j.fct.2006.07.020

DO - 10.1016/j.fct.2006.07.020

M3 - Journal article

C2 - 17027137

SN - 0278-6915

VL - 45

SP - 79

EP - 87

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

IS - 1

ER -