Compositions and methods for administering
View Patent ↗Mucosal administration of OspA and compositions therefor are disclosed and claimed. More particularly, oral administration of OspA and compositions therefor for eliciting an immunological response against Borrelia burgdorferi , such as a protective response preventive of Lyme disease are disclosed and claimed. Thus, oral Lyme disease vaccines or immunological compositions and methods of use are disclosed and claimed.
1. A method for inducing an immunological response, including OspA specific serum IgA antibodies in a mammalian host susceptible to Lyme disease or Borrelia burgdorferi infection comprising orally administering a composition comprising substantially pure outer surface protein A (OspA) and a carrier or diluent which is free of any immunogenicity-enhancing adjuvant.
2. The method of claim 1 wherein the OspA is lipidated OspA.
3. The method of claim 1 wherein the carrier or diluent is a liquid.
4. The method of claim 1 wherein the OspA is recombinant OspA.
5. The method of claim 4 wherein the OspA is lipidated.
6. The method of claim 5 wherein the OspA is obtained by: transforming a host organism by a plasmid containing a gene coding for a full-length wild-type Borrelia burgdorferi OspA lipoprotein and producing recombinant Borrelia burgdorferi OspA lipoprotein, and purifying the recombinant Borrelia burgdorferi OspA lipoprotein substantially free from other bacterial proteins, and from lipopolysaccharide, under non-denaturing conditions from a lysate of the host organism so as to obtain a purified recombinant Borrella burgdorferi OspA lipoprotein which remains lipidated and is in a form administrable to the host.
7. The method of claim 1 wherein the composition comprising substantially pure OspA and a carrier or diluent is a solution, suspension, emulsion, syrup, elixir, capsule, tablet, hard-candy-like preparation, or a solid food item.