DENDRITIC HUMAN UNIVERSAL NON-ANTIGEN EDUCAP VACCINE

Abstract

A non-antigenic microRNA exosomal vaccination that includes dendritic-derived exosomes resulting from the incubation of dendritic cells with Spike Protein of a COVID-19 virus so that the dendritic cells process the Spike Protein of the COVID-19 virus to enable education of naïve T-cells. The exosomes so-derived are then harvested and encapsulated for delayed release oral capsule delivery to selectively reach intestinal antigen-presenting cells in the terminal ileum for stimulating an acquired immune response to the Spike Protein of the COVID-19 virus. The intestinal antigen-presenting cells incorporate the dendritic-derived exosomes, and thereby learn to recognize the Spike Protein as a threat, even though no dangerous antigens, RNA, or DNA modifications of the antigen or Spike Protein of the COVID-19 virus were introduced by the non-antigenic microRNA exosomal vaccine, thereby avoiding creation of new pandemic viral emergencies, cytokine storms, mitochondrial aerobic failure, serious illnesses, and death via mutated strains of the COVID-19 virus.

Claims

1. A method of immunizing a subject against a molecule-caused disease without introducing an antigen associated with the molecule-caused disease, the method comprising: administering an effective amount of one or more exosomes to the subject, wherein each exosome is isolated from a dendritic culture of sigma one protein incubated with an immunogenic substance associated with the molecule-caused disease.

2. The method of claim 1, wherein said effective amount is encapsulated.

3. The method of claim 1, further comprising orally administering an encapsulated effective amount to target intestinal antigen-presenting cells.

4. A composition for immunizing against a molecule-caused disease, the composition comprising: one or more exosomes isolated from a dendritic culture of sigma one protein incubated with an immunogenic substance associated with the molecule-caused disease.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The invention will be more fully understood from the following detailed description, in conjunction with the following figures, wherein:

[0025] FIG. 1 is a flowchart of an exemplary embodiment of the present invention;

[0026] FIG. 2 is a flowchart of an exemplary embodiment of the present invention;

[0027] FIG. 3 is a diagrammatic view of pandemic-induced chaos which the present invention aims to avert;

[0028] FIG. 4 is a schematic view of the dendritic culture Sigma One receptor ACE2 protein;

[0029] FIG. 5A is a schematic view of an exemplary embodiment of the present Invention;

[0030] FIG. 5B is a schematic view of an exemplary embodiment of the present invention;

[0031] FIG. 6 is a schematic view of the trained Sigma One exosomes released in culture;

[0032] FIG. 7 is a schematic view of the Sigma One liposomes packages in micelles;

[0033] FIG. 8 is a schematic view of the exosomes neurological memory solid state immunity T-cells and B-cells;

[0034] FIG. 9 is a schematic view of an exemplary embodiment of the present invention;

[0035] FIG. 10 is a schematic view of an exemplary embodiment of the present invention;

[0036] FIG. 11 is a schematic view of a Delayed Release oral capsule;

[0037] FIG. 12 is a schematic view of the SAFE GI transfer EduCaps™ to acceptor T-cells and B-cells;

[0038] FIG. 13 is a schematic view of the exosome micro-vesicle's solid state immunity molecules;

[0039] FIG. 14 is a diagrammatic view of the systems dynamic memory immunity;

[0040] FIG. 15 is a diagrammatic view of the vaccine trail steps;

[0041] FIG. 16 is a diagrammatic view of an exemplary embodiment of the present invention;

[0042] FIG. 17 is a diagrammatic view of the return to an open world;

[0043] FIG. 18 is a diagrammatic view of the U.S. public private partnership;

[0044] FIG. 19 is a diagrammatic view of the post pandemic open safe world; and

[0045] FIG. 20 is a diagrammatic view of an exemplary embodiment of the present invention.

DETAILED DESCRIPTION

[0046] Broadly, the present invention provides a non-antigenic vaccination composition, method, and system that embodies dendritic-derived exosomes resulting from the incubation of dendritic cells with the Spike Protein of COVID-19, the Spike Protein including an RBD portion that is common to ALL variants of COVID-19 in such a way that the dendritic cells process the Spike Protein of COVID-19 for presentation so as to enable immune education of naïve T-cells and B-cells. The exosomes derived from those incubated dendritic cells are harvested and encapsulated for oral delivery so as to be released within the terminal ileum having exosome receptor cells. The exosome receptor cells transfer the exosomes to the splanchnic circulation to the liver sinusoids, spleen, and bone marrow, thereby conferring an acquired immune response to the COVID-19 virus, and all variants thereof. Acquiring an immune response to the COVID-19 virus (or any variant), in the manner according to the invention, does not expose the person to the COVID-19 virus, or any dangerous antigens thereof.

[0047] The EduCaps™ of the invention do not cause the person's cells to create Spike Proteins for immune education. Instead, EduCaps stimulates both cellular T-cell viral killing, and humoral B-cell viral identification immunity. By contrast, all known mRNA and DNA vaccines only generate partial B-cell viral identification (non-killing) immunity. For example, the partial B-cell viral immunity does not stop other sub-strains, such as the Delta variant and the Mu variant. Further, EduCap™ vaccination against COVID-19 does not create new viral strains that can evade EduCap™ immune identification and elimination. By contrast, known mRNA and DNA vaccines create new variants that selectively avoid the partial immunity provided by such vaccines.

[0048] EduCaps™ avoid the possibility of new pandemic viral emergencies, cytokine storms, mitochondria aerobic failure, serious illnesses, or death via variant strains of COVID-19. Thus, EduCaps™ provide a safe dendritic human non-antigenic encapsulated vaccine that transfers recognition of the immunogenic substance/virus to the human immune system.

[0049] The present invention blocks and terminates COVID-19 viruses (or variants) from attaching to the ACE2 receptor of the human Sigma One RBD antigen, thereby blocking viral entry into human cells by COVID-19 or any variant. Since the Sigma One RBD antigen is common to ALL COVID variants that can affect humans, EduCaps™ do not cause variants that can spread or become selectively dominant as a result of EduCap™ vaccination.

[0050] Referring now to FIGS. 1 through 20, the present invention includes a method and system of programming immune memory molecules for whole body protection. The process incorporates the following steps: step 1, immune dendritic culture of Sigma One protein of COVID-19; step 2, exosome miRNA memory molecule extraction (five to seven days); step 3, protection of trained memory (solution of) exosomes Sigma One protein recognition—e.g., including freeze-drying the exosomes, and then enclosing them in Delayed Release (DR) oralcapsules; step 4, taking the Delayed Release oral capsules containing the freeze-dried exosome-containing miRNA EduCaps™ via oral ingestion (e.g., swallowing) (EduCaps™ are stable at room temperature, taken with water, juice, or fluids) the exosomes containing miRNA to be micellized at the terminal ileum and then absorbed for entry into the splanchnic circulation to the liver sinusoids, the spleen, and the bone marrow to train the T-cells and B-cells residing therein; and step 5, monitor blood immune T-cell cellular and B-cell immunoglobulin response in 4 to 6 weeks (including blood labs immunological assay) for verification of immune transfer memory effectuation. This educates the immune system, particularly, IgG4 T-cell virus killing and B-cell viral tagging IgM antibodies. By performing lab testing at two to four weeks after consuming the oral EduCaps™, detectable antibodies can be measured that indicate successful immune memory transfer. Immune memory transfer includes transfer of miRNA (microRNA) that contain information that enables IgG4 T-cell viral killing capacity, and B-cell viral identification capacity. This creates long term T-cell and B-cell immunity, thereby providing complete viral illness protection.

[0051] Antigen transfer to dendritic cells creates exosomes that educate the immune system to recognize COVID-19 and variants, and to identify and kill the COVID-19 virus attaching to the ACE2 receptor.

[0052] Thus, immune memory molecules (microRNA) are contained within exosomes, which are dried and then encapsulated for pH protection from stomach acid and digestive enzymes (e.g., using Lonza® Capsugel® DR™ capsules). Dendritic exosomes transfer immune information to T-cells and Bells throughout the body, thereby providing to the person consuming the EduCaps™ cellular and humoral immune protection from COVID-19, and all variants thereof.

[0053] The present invention can be manufactured using a bioreactor with standardized universal human dendritic cells, and standardized Spike Protein antigen for incubation therewith. The standardized universal human dendritic cells and Spike Protein together after 5-7 days of incubation, generate immune-training exosomes effective against COVID-19 and variants. The immune-training exosomes are then freeze-dried, and then encapsulated within Delayed Release Capsules (such as LONZA® Capsugel® DR™ capsules) without any binders or adjuvants, thereby providing oral EduCaps™. The oral EduCaps™ of the invention provide symptom-free induction of immunity to COVID-19 and all variants thereof, without infection by COVID-19 or variants, and without symptoms of COVID-19 or variants.

[0054] A user can orally consume one EduCap™ capsule for each of seven days, with water or juice, thereby providing the user with immune education against COVID-19 or any variant thereof, without suffering any toxicity or side effects, and without experiencing any symptoms of COVID-19 or any variant thereof.

[0055] It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention, and that modifications can be made without departing from the spirit and scope of the invention as set forth in the following claims.