PMID: 9554282Apr 29, 1998Paper

Development of an animal model to assess the immunogenicity of single-dose tetanus and diphtheria vaccines based on controlled release from biodegradable polymer microspheres

Developments in Biological Standardization
R K GuptaG R Siber

Abstract

We have determined threshold doses of aluminium phosphate (AlPO4) adsorbed tetanus toxoid (TT) and diphtheria toxoid (DT) in mice and guinea pigs with a view to developing an animal model to assess the immunogenicity of controlled release vaccines. A dose was sought (threshold dose) which produces little antibody after primary injection and a moderate response after a booster injection, thus mimicking the adult human response to TT and DT vaccines adsorbed on to aluminium adjuvants. After the first injection, mice and guinea pigs showed a dose response for both tetanus toxin IgG antibodies and tetanus antitoxin over a wide range of doses of AlPO4-adsorbed TT (0.01 to 0.2 Lf). After the second and third injections, there was no clear dose response for doses between 0.05 and 0.2 Lf However, doses between 0.01 and 0.04 Lf still showed a dose response after the second injection. Dilution of AlPO4-adsorbed TT in saline just before injection did not alter immunogenicity after the first injection, but stronger booster responses were seen in mice to diluted versus undiluted vaccine after the second and third injections. The threshold dose of AlPO4-adsorbed TT for both mice and guinea pigs was 0.01 Lf given in 100 microliters. For AlPO4...Continue Reading

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