Formulations that Provide Support During Vaccinations and Adaptive Immune System Response

Abstract

The present invention provides formulations that support an individual's body during routine vaccination and adaptive immune response. The individuals who can benefit from these formulations are infants, children and adults. The formulations comprise ingredients that can be administered prior to, concurrent with or subsequent to the vaccination. The formulations of the present invention preferably act by targeting enzymatic reactions an individual's various metabolic pathways, maintaining balance between oxidative stress and methylation, maintaining balance between Th1 and Th2 responses, or a combination thereof during vaccination and adaptive immune response.

What is claimed is: 
     
         1 . A method of supporting the healthy state of an individual's body in conjunction with receipt of vaccinations and during adaptive immune responses which target epigenetic regulation of gene expression, specific enzymatic reactions, cytokine differentiation, immune system homeostasis and proper functioning of various metabolic pathways thereby improving antibody response and decreasing vaccine side effects by positively affecting the balance between oxidative stress, methylation, transsulfuration and maintaining the balance between TH1 and Th2 response, comprising:
 administering a pharmacologically acceptable amount, to an individual, of the following formulation:   1 mg -10 mg of thiamin (Vitamin B1), 0.1 mg-500 mg of riboflavin (Vitamin B2) 0.5 mg-1 g of niacin (Vitamin B3), 0.5 mg-10 mg of pantothenic acid (Vitamin B5), 0.1 mg-25 mg of pyridoxine (Vitamin B6), 5 mcg-1 mg of folate (vitamin 139), 10 mcg-5,000 mcg of cobalamin (Vitamin B12), 10 mcg-1,000 mcg of Vitamin A, 50 IU-1,000 IU of Vitamin D, 1 mg-20 mg of Vitamin E, 5 mg-5,000 mg of Vitamin C, 0,5 mcg-300 mcg, of Vitamin K, 50 mg-800 mg of Calcium, 20 mcg-15 mg of Iodine, 5 mg-200 mg of Magnesium, 1 mg-15 mg of Zinc, 5 mcg-200 mcg of Selenium, 0.1 mg-5 mg of Manganese, 1 mcg-150 mcg of chromium, 1 mcg-100 mcg of molybdenum, 10 mg-1 g of trimethylglycine (betaine), 10 mg-1 g of choline, 50 mg-2 g of acetyl-L-carnitine, 20 mg-500 mg of N-acetyl cysteine, 50 mg-800 mg, of milk thistle and 20 mg-800 mg of creatinine or a combination thereof;   administering said formulation prior to the administration of a vaccine, concurrent with the administration of a vaccine or subsequent to the administration of a vaccine; and   administrating said formulation to said individual where the individual is an infant, a toddler, a teenager or an adult.   
     
     
         2 . The method of  claim 1 , wherein said administered formulation is administered orally, intramuscularly, intradermally, intravenously, nasally, subcutaneously, intraperitoneally or any other suitable route of administration. 
     
     
         3 . The method of  claim 1 , wherein said administered formulation is delivered via capsules, tablets, syrups, liquids, injectables or any suitable dosage forms. 
     
     
         4 . The method of  claim 1 , wherein said administered formulation further comprises:
 a pharmaceutically acceptable carrier or carriers; and   a pharmaceutically acceptable excipient or excipients including flavoring agents, coloring agents, stabilizing agents, binders, fillers, disintegrants, diluents and/or other well-accepted types of excipients that are safe and effective for human use and consumption.   
     
     
         5 . The method of  claim 1 , wherein said administered formulation beneficially targets metabolic pathways comprising trans-methylation, trans-sulfuration, the citric acid cycle, biopterin production, amino acid metabolism, mitochondrial function and/or a combination thereof. 
     
     
         6 . The method of  claim 1 , wherein administration of said formulation maintains the balance between the TH1 and Th2 responses by regulating methylation of specific CpG islands and by regulating the proper functioning of cytokines interferon gamma (IFN-γ), IL-4, IL-5, IL-13, IL-10, IL-25, IL-31, or IL-33. 
     
     
         7 . The method of  claim 1 , wherein administration of said formulation has beneficial effects on various metabolic and biochemical reactions and systems including the immune system, cell membrane integrity, detoxification, s-adenosylmethionine (SAM) production, DNA synthesis and repair, glutathione production, and maintenance, support and maintenance of a healthy nervous system. 
     
     
         8 . The method of  claim 1 , wherein the administered formulation contains:
 B vitamins beneficially involved in energy production and metabolism;   cysteine essential for glutathione production;   choline integral to cellular membrane stability;   milk thistle acting as hepatoprotective, an antioxidant, a toxin blocker, an immunomodulator, an anti-inflammatory and as an essential component for protein synthesis;   carnitine acting as an antioxidant and a support of proper mitochondrial function through regulation of fatty acid metabolism and energy production;   trimethylglycine acting to hydrate cells and to support methylation by providing reactive methyl donors, increasing S-adenosyl methionine levels and reducing homocysteine levels;   creatine to support energy metabolism and lighten the majority demand of methyltransferase activity by providing the end product of guanidinoacetate N-methyltransferase (GAMT); and   Vitamin A, Vitamin D, Vitamin E, Vitamin K, Calcium, Iodine, Magnesium, Zinc, Selenium, Manganese and Molybdenum for their roles as essential components to a properly functioning, healthy individual undergoing vaccination and/or an adaptive immune response.   
     
     
         9 . The method of  claim 1 , wherein levels of biologic biomarkers may be collected and measured, via samples at the DNA, RNA and/or protein level, in vitro or ex vivo, before and after the administration of said formulation, to provide accurate and reliable testing, analysis and measurement to determine the effectiveness of said formulation on immune system functioning and adaptive immune responses, specifically, and various metabolic and biochemical reactions and systems, generally. 
     
     
         10 . The method of  claim 1 , wherein biologic biomarkers may be measured and assessed through blood, serum or plasma samples, before, during and after formulation administration, to determine the effectiveness of said formulation on supporting an individual's body during vaccination, an individual's immune system function and adaptive immunity. 
     
     
         11 . The method of supplying supportive immunization protocols targeting epigenetic expression, enzymatic kinetics and immune system homeostasis to improve vaccine response and reduce vaccine side effects by beneficially maintaining the balance between oxidative stress and methylation, by targeting gene expression for proper enzymatic reactions involved in various metabolic pathways, thereby reducing the effects of oxidative stress through the reduction in reactive oxygen species, support of methylation, supporting trans-sulfuration and proper glutathione production and support comprising:
 collecting a preliminary biomarker sample from an individual;   assessing base levels of biomarkers, via a biochemical assay, to determine an individual's pre-administration biomarker status;   administering a pharmacologically acceptable amount, to an individual, of the following formulation:   1 mg -10 mg of thiamin (Vitamin B1), 0.1 mg-500 mg of riboflavin (Vitamin B2), 0.5 mg-1 g of niacin (Vitamin B3), 0.5 mg-10 mg of pantothenic acid (Vitamin B5), 0.1 mg-25 mg of pyridoxine (Vitamin B6), 5 mcg-1 mg of folate (vitamin B9), 10 mcg-5,000 mcg of cobalamin (Vitamin B12), 10 mcg-1,000 mcg of Vitamin A, 50 IU-1,000 IU of Vitamin D, 1 mg-20 mg of Vitamin E, 5 mg-5,000 mg of Vitamin C, 0.5 mcg-300 mcg, of Vitamin K, 50 mg-800 mg of Calcium, 20 mcg-15 mg of Iodine, 5 mg-200 mg of Magnesium, 1 mg-15 mg of Zinc, 5 mcg-200 meg of Selenium, 0.1 mg-5 mg of Manganese, 1 mcg-150 mcg of chromium, 1 mcg-100 mcg of molybdenum, 10 mg-1 g of trimethylglycine (betaine), 10 mg-1 g of choline, 50 mg-2 g of acetyl-L-carnitine, 20 mg-500 mg of N-acetyl cysteine, 50 mg-800 mg, of milk thistle and 20 mg-800 mg of creatinine or a combination thereof;   administering said formulation prior to the administration of a vaccine, concurrent with the administration of a vaccine or subsequent to the administration of a vaccine; and   measuring, by a biochemical assay, the subsequent levels of biomarkers.   
     
     
         12 . The method of  claim 11 , wherein the analysis of collected levels of biomarkers, before, during and/or after administration of said formulation, measures the effectiveness of said supportive immunization protocols by assessing the systemic degrees of individual and/or combinations or ratios of the following:
 methylation;   transmethylation;   trans-sulfuration;   creatine synthesis;   cytokines released by TH1 and Th2 cells including interferon gamma (IFN-γ), IL-4, IL-5, IL-10, IL-25, IL-31, or IL-33;   cytokine differentiation;   the ratio of reduced glutathione to oxidized glutathione;   glutathione synthesis and production;   mitochondrial function;   adenosine synthesis;   phospholipid synthesis;   serotonin and melatonin production;   biopterin (BH4) synthesis;   amino acid metabolism;   arginine metabolism;   s-adenosylmethionine production;   catecholamine production; and   CpG island methylation; and/or a combination thereof.   
     
     
         13 . The method of  claim 11 , wherein the effects of said supportive immunization protocols is ascertained by determining the levels of biomarkers by measuring the effects of said formulation, directly and indirectly, on an individual's vaccine response, immune system response and/or on an effectively operating adaptive immune response. 
     
     
         14 . The method of  claim 11 , wherein biomarker levels may be determined by intracellular cytokine staining, flow cytometry, Elispot assay, RNAse protection assay, Northern blot, ELISA and/or any other suitable detection and analysis techniques as may be required to determine said levels of biomarkers. 
     
     
         15 . The method of  claim 11 , wherein degree or percentage of methylation and transmethylation may be measured by Polymerase Chain Reaction (PCR), DNA sequencing or any other suitable means of determining methylation and transmethylation levels, degrees, combinations or ratios. 
     
     
         16 . The method of  claim 11 , wherein degree, percentage and rations of methylation and oxidation are measured by polymerase Chain Reaction (PCR), DNA, RNA sequencing or measured protein levels using appropriate bioassays. 
     
     
         17 . The method of  claim 11 , wherein levels of biomarkers can be measured via biomarker samples at the DNA, RNA and/or protein level, in vitro or ex vivo, before, during and after the administration of the formulation to provide for accurate and reliable testing, analysis and measurement to determine the effectiveness of said formulation at various stages on an individual's biological and metabolic functioning. 
     
     
         18 . The method of  claim 11 , wherein said supportive immunization and adaptive immunity protocols' effectiveness is measured directly or indirectly, before, during and/or after formulation administration, by collecting and analyzing samples of the following formulation ingredients:
 B vitamins including thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, folate, and cobalamin;   Vitamin A;   Vitamin D;   Vitamin E;   Vitamin C;   Vitamin K;   Calcium;   Iodine;   Magnesium;   Zinc;   Selenium;   Manganese;   Chromium;   Molybendum;   Trimethylglycine;   Choline;   Carnitine in the form of acetyl-1-carnitine;   N-acetyl cysteine, cysteine and homocysteine;   trimethyl glycine;   creatine;   cytokines released by TH1 and Th2 cells including interferon gamma (IFN-γ), IL-4, IL-5, IL-13, IL-10, IL-25, IL-31, or IL-33; and/or   combinations thereof.   
     
     
         19 . The method of  claim 11 , wherein collected biomarker samples are obtained through collected blood, plasma or serum. 
     
     
         20 . The method of  claim 18 , wherein samples are obtained through collected blood, plasma or serum.