Lack of immunogenicity of ice structuring protein type III HPLC12 preparation administered by the oral route to human volunteers.
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.
Crevel
R W R
RW
Safety and Environmental Assurance Centre, Sharnbrook, Unilever Colworth, Bedford MK44 1LQ, UK, and Allergy Center, Odense University Hospital, Denmark. rene.crevel@unilever.com
Cooper
K J
KJ
Poulsen
L K
LK
Hummelshoj
L
L
Bindslev-Jensen
C
C
Burks
A W
AW
Sampson
H A
HA
D000276:Adjuvants, Immunologic / Q000009:adverse effects* / Q000737:chemistry / Q000145:classification; D000284:Administration, Oral; D000328:Adult; D000485:Allergens / Q000009:adverse effects* / Q000737:chemistry / Q000276:immunology; D021343:Antifreeze Proteins, Type III / Q000009:adverse effects* / Q000737:chemistry / Q000276:immunology; D001491:Basophils / Q000187:drug effects / Q000378:metabolism; D004044:Dietary Proteins / Q000009:adverse effects* / Q000145:classification / Q000276:immunology; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005512:Food Hypersensitivity; D006632:Histamine / Q000378:metabolism; D006801:Humans; D015151:Immunoblotting; D007073:Immunoglobulin E / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D016037:Single-Blind Method; D012882:Skin Tests; D018675:Toxicity Tests
D000276:Adjuvants, Immunologic; D000485:Allergens; D021343:Antifreeze Proteins, Type III; D004044:Dietary Proteins; D007074:Immunoglobulin G; D007073:Immunoglobulin E; D006632:Histamine