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We evaluated a novel mucosal adjuvant that consists of a nontoxic, water-in-oil nanoemulsion (NE). This material does not contain a proinflammatory component but penetrates mucosal surfaces to load antigens into dendritic cells. Mice and guinea pigs were intranasally immunized with recombinant<jats:italic>Bacillus anthracis<\/jats:italic>protective antigen (rPA) mixed in NE as an adjuvant. rPA-NE immunization was effective in inducing both serum anti-PA immunoglobulin G (IgG) and bronchial anti-PA IgA and IgG antibodies after either one or two mucosal administrations. Serum anti-PA IgG2a and IgG2b antibodies and PA-specific cytokine induction after immunization indicate a Th1-polarized immune response. rPA-NE immunization also produced high titers of lethal-toxin-neutralizing serum antibodies in both mice and guinea pigs. Guinea pigs nasally immunized with rPA-NE vaccine were protected against an intradermal challenge with \u223c1,000 times the 50% lethal dose (\u223c1,000\u00d7 LD<jats:sub>50<\/jats:sub>) of<jats:italic>B. anthracis<\/jats:italic>Ames strain spores (1.38 \u00d7 10<jats:sup>3<\/jats:sup>spores), which killed control animals within 96 h. Nasal immunization also resulted in 70% and 40% survival rates against intranasal challenge with 10\u00d7 LD<jats:sub>50<\/jats:sub>and 100\u00d7 LD<jats:sub>50<\/jats:sub>(1.2 \u00d7 10<jats:sup>6<\/jats:sup>and 1.2 \u00d7 10<jats:sup>7<\/jats:sup>) Ames strain spores. Our results indicate that NE can effectively adjuvant rPA for intranasal immunization. This potentially could lead to a needle-free anthrax vaccine requiring fewer doses and having fewer side effects than the currently available human vaccine.<\/jats:p>","DOI":"10.1128\/iai.00070-07","type":"journal-article","created":{"date-parts":[[2007,5,15]],"date-time":"2007-05-15T00:58:35Z","timestamp":1179190715000},"page":"4020-4029","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":123,"title":["Mucosal Immunization with a Novel Nanoemulsion-Based Recombinant Anthrax Protective Antigen Vaccine Protects against<i>Bacillus anthracis<\/i>Spore Challenge"],"prefix":"10.1128","volume":"75","author":[{"given":"Anna U.","family":"Bielinska","sequence":"first","affiliation":[{"name":"Michigan Nanotechnology Institute for Medicine and Biological Sciences, University of Michigan, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katarzyna W.","family":"Janczak","sequence":"additional","affiliation":[{"name":"Michigan Nanotechnology Institute for Medicine and Biological Sciences, University of Michigan, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey J.","family":"Landers","sequence":"additional","affiliation":[{"name":"Michigan Nanotechnology Institute for Medicine and Biological Sciences, University of Michigan, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Makidon","sequence":"additional","affiliation":[{"name":"Michigan Nanotechnology Institute for Medicine and Biological Sciences, University of Michigan, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurie E.","family":"Sower","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, University of Texas Medical Branch, Galveston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johnny W.","family":"Peterson","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, University of Texas Medical Branch, Galveston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"James R.","family":"Baker","sequence":"additional","affiliation":[{"name":"Michigan Nanotechnology Institute for Medicine and Biological Sciences, University of Michigan, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0014-5793(02)03609-8"},{"key":"e_1_3_2_3_2","first-page":"609","volume":"9","year":"2001","unstructured":"Baillie, L. 2001. 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