Oral vaccine comprising antigen surface-associated with red bloo

Details Oral vaccine comprising antigen surface-associated with red bloo Oral vaccine comprising antigen surface-associated with red bloo

1992-10-23

1997-07-01

Smith, Lynette F.

Drug, bio-affecting and body treating compositions

Antigen, epitope, or other immunospecific immunoeffector

Virus or component thereof

42419611, 4241941, 4241931, 4242041, A61K 39145, A61K 3912, A61K 39385

Patent

active

056435770

DESCRIPTION:

BRIEF SUMMARY
This invention relates generally to vaccines and in particular, although not limited to, influenza vaccines appropriate for oral administration.
Currently, most vaccines are administered parenterally with consequent problems arising from the invasive nature of the administration route. For instance, it has been proposed, in U.S. Pat. No. 4,157,390 to use red blood cells as vehicles for the presentation of enteropathogenic antigens in a parenteral vaccine administered to prepartum sows. A further disadvantage of parenteral administration is that, in general, it induces a better blood borne immune response than a mucosal one, yet the prophylaxis or treatment of some infective agents is more appropriately dealt with by a strong mucosal immunity. The parenteral nature of prior art vaccines has not in general resulted in a strong mucosal response.
To redress some of these problems, orally administered vaccines have been proposed against various infective agents. Unfortunately as the alimentary tract provides a hostile environment, it is only fortuitously, such as in the Sabin vaccine, that these have been effective.
It is an object of the present invention to provide a vaccine which redresses some of the disadvantages experienced in the past.
It has now been found that red blood cells and their derivatives can provide a potent orally administered vehicle for the presentation of antigens to the mucosal immune system. Therefore in accordance with a first aspect of the invention there is provided an oral vaccine comprising antigen surface-associated with red blood cells or derivatives thereof.
A second aspect of the invention provides a method of eliciting an immunoresponse, particularly a mucosal immune response, in a mammal the method comprising the oral administration of a vaccine as defined immediately above.
In general, the antigen will derive from an infectious agent. Such an infectious agent may be a virus, in particular those viruses in which a mucosal immunoresponse appears important in prophylaxis or acute infection. Examples of these include respiratory viruses such as influenza or rhinovirus, polio and certain gastrointestinal infections such as rotavirus. Other infections of mucosal like tissue include E. coli infections of the urinary tract and chlamydia infection of the eye in trachoma. The present invention can also invoke a systemic immunity suggesting uses in systemic infections such as hepatitis or tetanus. Other immunizing applications such as those intended for anti-allergy or contraceptive treatment may also be appropriate. The antigen may comprise a plurality of antigens to produce a multivalent vaccine for all strains of, for instance, influenza, present in a season. Alternatively or additionally, the antigen may comprise a plurality of antigens from different organisms thus leading to a single vaccine effective against more than one disease or condition.
The invention is not limited to the use of whole red blood cells in the vaccine, because derivatives thereof, such as ghosts or membrane preparations, can also yield the desired enhanced mucosal immunogenicity. One observation has been that the use of red blood cells provides extremely uniform size particles within the optimal 5 to 10 .mu.m range optimally taken up by Peyers patches, see, for instance Jones et al. (1988) Scand. J. Immunol., 27, 645. Thus, by the use of the invention, an antigen can be effectively targeted to the Peyers patches, the "mucosal motor" for the activation of the common mucosal system. Previous attempts to target Peyers patches have failed due to difficulties in creating discrete uniform size particles, as shown by Kreuter et al. (1981) J. Pharmaceutical Sci., 70, 367.
An advantage of the orally administered red blood cell (or derivative) system of the present invention is that due to previous dietary exposure, the red blood cells are immunologically well tolerated by most individuals. It is therefore desirable that the red blood cells should originate from farm animals such as chickens, ducks, cows or sheep. Alt

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