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  • Title: Enhanced immunogenicity of microencapsulated tetanus toxoid with stabilizing agents.
    Author: Audran R, Men Y, Johansen P, Gander B, Corradin G.
    Journal: Pharm Res; 1998 Jul; 15(7):1111-6. PubMed ID: 9688068.
    Abstract:
    PURPOSE: Antigenic proteins encapsulated in biodegradable polyester microspheres (MS) can slowly denature or aggregate, which results in decreased antigenicity. In this study, we have evaluated the ability of co-encapsulated additives to protect against the loss of tetanus toxoid (TT) antigenicity. METHODS: Antibody responses were analyzed after immunization of mice with TT microencapsulated in the presence of additives (TT-MS-additive). RESULTS: Immunization with TT-MS-additives gave rise to higher responses than those obtained in the absence of additive. BSA, trehalose. Gamma-hydroxypropylcyclodextrin and calcium salts preserved the immunogenicity of the incorporated antigen with the highest efficacy. Sustained responses were obtained with mixtures of fast and slowly releasing TT-MS containing BSA plus trehalose or calcium salts. CONCLUSIONS: The selected additives may stabilize the antigen in MS during storage and rehydration in body fluids. Regulated antigen release from MS-based vaccines permits a reduction of the antigen dose and optimization of single-dose vaccine formulations.
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