Objective: To study the safety, immunogenicity on the enterotoxige Escherichia coli (E. coli) recombinant active vaccine FE3 and FE16.

Methods: Toxicity and immunogenicity of the vaccine were determined by experiments on enterotoxigenic E. coli toxicity and immunological experiments on rabbits and mice.

Results: The results of an toxicological experiments were negative. The agglutination titer of antibodies against the S. flexneri 2a and enterotoxigenic E. coli plamid antigen were all higher than 1:640 and 1:1280 in the sera of rabbits. IgG in the serum went up remarkably, while sIgA against CFA/I was also decteted in the dejecta of mice immunized with active bacteria either orogastrically or intranasally. Simultaneously, sIgA was not detected in the dejecta of mice immunized with inactive bacteria either orogastrically or intranasally.

Conclusion: The enterotoxigenic E. coli recombinant active vaccine showed good safety and immunogenicity, inducing both humoral and mucosal immunity in mice.

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