Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector
Reexamination Certificate
2001-02-28
2003-10-21
Housel, James (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
C424S203100, C424S204100, C424S278100
Reexamination Certificate
active
06635253
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition for enhancing the immunological effects of a vaccine for viruses, bacteria and/or infectious disease pathogens, containing “a stable activity provitamin such as an L-ascorbic acid-2-phosphate and/or &agr;-tocopheryl phosphate” (hereinafter referred to as a “provitamin”) as an active ingredient. The present invention also relates to a method for enhancing the immunological effects of a vaccine for viruses, bacteria and/or infectious disease pathogens by administering the composition and to a method of employing the composition.
BACKGROUND OF THE INVENTION
By virtue of the development of a vaccine or an antibiotic, humans and animals under feeding, such as cattle, pet and bleeding marine animal, have been protected from infectious diseases caused by various viruses or bacteria. In other words, the discovery of antibiotics for specific bacterial infectious diseases has already succeeded in greatly mitigating the fear of bacterial diseases. However, antibiotics or chemotherapics effective for virally infectious diseases are small in number and the predominating prophylaxis is a vaccine inoculation represented by poliomyelitis and vaccination.
Vaccines in general include an “inactivated vaccine” obtained by the inactivation of a pathogenesis virus and a “live vaccine” obtained by the attenuation thereof. Presently, examples of the vaccine practically used for humans include vaccines of poliomyelitis, measles, rubella, mumps, influenza, Japanese B encephalitis, varicella, icterus and hepatitis B. Among these, vaccines of influenza, Japanese B encephalitis and hepatitis B belong to the “inactivated vaccine” and others belong to the “live vaccine”.
As compared to the inactivated vaccine, the live vaccine is generally advantageous in that immunity acquisition is close to that obtained by natural infection and the immunological effects are high. However, the live vaccine is said to have problems, such as toxicity may recover or the quality is unstable. On the other hand, the inactivated vaccine, which is lower in toxicity than the live vaccine, is not completely free of toxicity, and aggressive studies are being made with an attempt to develop more safe and effective component vaccines using genetic engineering means. However, these vaccines have some problems in practical use.
As described above, many vaccines are being used in practice; however, their prophylactic effect is not sufficiently high and various methods for enhancing the immunological effects of vaccine are being studied. For example, use of an adjuvant is one means for enhancing the effect of vaccine. A long known synthetic Freund's adjuvant has also been attempted, but this adjuvant disadvantageously causes a strong adverse reaction, having a problem in safety.
In general, when a vaccine is inoculated to an organism, the immunological effects thereof can be determined by measuring the amount of specific antibody in blood.
In the case of an antigen having hemagglutination activity, such as influenza, the amount of specific antibody in blood can be measured by hemagglutination inhibition. More specifically, 2-fold step dilution series of a virus solution are prepared, a constant amount of erythrocytes are added to each dilution and after the passing of a predetermined amount of time, the agglutination images are examined. The HA unit (HAU) of the virus is the reciprocal of the highest dilution number in a test tube showing agglutination positive. Thereafter, 2-fold step dilution series of a serum to be measured on the antibody unit are similarly prepared, an equivalent virus solution diluted to 4 HAU is added to each dilution, and the dilutions are left standing for a predetermined amount of time. To each of these solutions, a constant amount of erythrocytes are added and after the passing of a predetermined amount of time, the agglutination images are examined. The antibody unit (HI unit, HIU) of the serum is the reciprocal of the highest dilution number in a test tube showing complete agglutination inhibition.
In the case of an antigen having no hemagglutination activity, the amount of specific antibody in blood can be measured by passive hemagglutination (PHA) or the like. In this method, an antigen is previously conjugated to erythrocytes by employing tannic acid or chromium chloride and the antibody unit of antiserum is quantitated as HA unit.
As described above, with respect to the live vaccine, there is a fear of occurrence of mutation of the attenuated toxicity strain in vivo into a strongly toxic strain. In addition, with respect to the inactivated vaccine, there is a fear of a latent danger in essence such that the antigenicity is distorted during the inactivation operation and this gives rise to an unexpected adverse reaction.
Apart from this, group administration of a vaccine is being performed at present for the young. Therefore, in order to prevent the adverse reaction ascribable to the dispersion of the sensitivity in the host side, a more safe and effective vaccine is being demanded.
Furthermore, in the case of a virus which causes infection and proliferates on the surface of respiratory tract, such as influenza virus, unless the local secretory antibody (IgA antibody) of the respiratory tract is present in a sufficiently high concentration, the virus infection cannot be prevented even if the antibody concentration in blood is high. At present, subcutaneous inoculation of an inactivated vaccine is employed for the prophylaxis of influenza. Although this method is effective for increasing the antibody in blood, the IgA antibody is not increased. Accordingly, for preventing the infection not only by the influenza but also by viruses which cause infection and proliferate on the surface of respiratory tract or on the mucosa of digestive tract, it is important to increase the IgA antibody in addition to the antibody in blood.
In order to solve the above-described problems, the present inventors have made extensive investigations on a method for enhancing the immunological effects of a vaccine based on the estimation that when the immunological effects of a vaccine are enhanced, the dose can be reduced and in turn, the frequency of generation of an adverse reaction can be reduced. As a result, it has been found that the above-described problems can be overcome by using a specific provitamin, namely, a specific antioxidant provitamin in combination with a vaccine. The present invention has been accomplished based on this finding.
SUMMARY OF THE INVENTION
More specifically, the present invention provides the following embodiments.
(1) A composition for enhancing the immunological effects of a vaccine for viruses, bacteria and/or infectious disease pathogens, comprising a stable activity-type antioxidant provitamin.
(2) The composition for enhancing the immunological effects as described in (1) above, wherein the provitamin is at least one phosphoric acid ester selected from L-ascorbic acid-2-phosphate, &agr;-tocopheryl phosphate and salts thereof.
(3) The composition for enhancing the immunological effects as described in (1) or (2) above, wherein the provitamin is selected from alkali metal salts and alkaline earth metal salts.
(4) The composition for enhancing the immunological effects as described in any one of (1) to (3) above, wherein the immunological effects of a vaccine is increased to 2 times or more in terms of the serum antibody unit.
(5) The composition for enhancing the immunological effects as described in (4) above, wherein the serum antibody unit is an antibody unit measured by hemagglutination inhibition (HAI) or passive hemagglutination (PHA).
(6) The composition for enhancing the immunological effects as described in any one of (1) to (3) above, wherein the action of enhancing immunological effects is an action of promoting the activation of macrophage.
(7) The composition for enhancing the immunological effects as described in any one of (1) to (3) above, wherein the action of enhancing the immunological effects is an ac
Ito Shinobu
Ogata Eiji
Foley Shanon
Housel James
Showa Denko Kabushiki Kaisha
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