Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798677
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2021-03-12
Brief Title:
Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
Sponsor:
AB Biotek
Organization:
AB Biotek
Study Overview
Official Title:
Efficacy and Tolerability of a Nutritional Supplementation With ABBC-1 a Symbiotic Combination of Beta-glucans and Selenium and Zinc Enriched Probiotics in Volunteers Receiving the Influenza or the Covid-19 Vaccines
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions Innate immunity can adapt and respond more efficiently to secondary exposures thanks to epigenetic and metabolic reprogramming namely trained immunity
ABBC1 is a combination of beta-1316-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity ABBC1 includes repurposed synergistic yeast-based ingredients a unique ß-1316-glucan complex and a consortium of probiotic Saccharomyces cerevisiae rich in Selenium and Zinc ABBC1 induces trained immunity due to its specific chemical and tridimensional structure its ß-glucan complex interacts with specific receptors in immune cells provoking a release of cytokines and priming phagocytosis Simultaneous activation of these pathways activates innate immunity and counteracts cytokine storm
ABBC1 provides highly bioavailable selenium and zinc micronutrients with a critical role in an optimal immune responsiveness to allergy infection and vaccines ABBC1 possesses proven microbiome modulating properties which revert in immune training Due to its high tolerance safety and immediate availability ABBC1 is an ideal candidate for complementary management of geriatric patients with seasonal influenza viruses or COVID-19 or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients including the elderly who are frequently polymedicated and allows adding an additional therapeutic tool in the fight against the pandemic
This study assesses the benefits of a nutritional supplementation with ABBC1 in volunteers receiving the influenza vaccine during autumn 2020 and the Covid-10 vaccine during winter 2021
ABBC1 is a combination of beta-1316-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity ABBC1 includes repurposed synergistic yeast-based ingredients a unique ß-1316-glucan complex and a consortium of probiotic Saccharomyces cerevisiae rich in Selenium and Zinc ABBC1 induces trained immunity due to its specific chemical and tridimensional structure its ß-glucan complex interacts with specific receptors in immune cells provoking a release of cytokines and priming phagocytosis Simultaneous activation of these pathways activates innate immunity and counteracts cytokine storm
ABBC1 provides highly bioavailable selenium and zinc micronutrients with a critical role in an optimal immune responsiveness to allergy infection and vaccines ABBC1 possesses proven microbiome modulating properties which revert in immune training Due to its high tolerance safety and immediate availability ABBC1 is an ideal candidate for complementary management of geriatric patients with seasonal influenza viruses or COVID-19 or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients including the elderly who are frequently polymedicated and allows adding an additional therapeutic tool in the fight against the pandemic
This study assesses the benefits of a nutritional supplementation with ABBC1 in volunteers receiving the influenza vaccine during autumn 2020 and the Covid-10 vaccine during winter 2021
Detailed Description:
On March 11 2020 the World Health Organization WHO declared the COVID-19 disease caused by SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2 as a pandemic The Covid-19 pandemic is evolving throughout the world and is associated with high mortality and morbidity According to Salem ML et al 2020 the influenza vaccine may have an adjuvant effect to minimize the severity of COVID-19 since the correlation of Covid-19-related mortality and morbidity and the influenza vaccination situation appears to be protective The trend of the correlation could be explained in parameters of incidence and recovery of cases
Vaccination against influenza H1N1 is cost-effective and safe Given that the influenza virus shares some common epitopes and mechanisms with the SARS-CoV-2 virus there is the possibility of partial protection for reduce severity related to Covid-19 through flu vaccination The influenza viruses and the SARS-CoV-2 viruses have an evolutionary proximity Since this vaccination is not mandatory for routine clinical practice various countries adopt different policies and vaccination rates differ considerably among them For this reason the WHO in February 2020 published a recommendation on the composition of vaccines against influenza virus for use in the 2020-2021 northern hemisphere influenza season
Under this situation it has been identified that older adults and people suffering from serious chronic conditions such as heart disease lung disease or kidney disease have a higher risk of suffering from severe COVID-19 Older people are twice as likely to have severe COVID-19 This is probably because as people age their immune systems change making it harder to fight off disease and infection and for this reason age is considered a risk factor for the disease
After several months of the global impact of the pandemic specific vaccines for Covid-19 will begin to be available by end 2020 In Spain the Ministry of Health designed a vaccination plan that will begin immediately Specifically in Catalonia this plan foresees classifying the population into various risk groups based on highest priority and immediacy Older adults make up one of the groups that will receive the vaccine as a priority At the same time they represent a population group whose immune response after the administration of other vaccines has been found to be less effective or optimal than in healthy adults under 65 years of age For example the influenza vaccine has an efficacy of 70-90 in the general population while this efficacy is reduced to 17-53 in adults older than 65 years In the same line preliminary results with Covid-19 vaccines observe a better efficacy 90 in groups of people under 55 years of age compared to those over 55 years of age 62 results that suggest that the efficacy could decrease with age
The reduced efficacy of vaccines in the elderly may be because the geriatric population frequently presents immunosenescence or a decline in immune function due to aging but also to a possible poor nutritional status in which it is not achieved to reach an optimal supply of essential oligonutrients for an effective antiviral immune response
Specifically the efficacy data for the BNT162b2 vaccine in people older than 65 years considered a risk population point to a slightly lower efficacy 917 versus 948 in the general population However the results point to less protection after the administration of a single dose of the vaccine 820 efficacy just after the administration of the first dose and 524 between doses 1 and 2 compared to 948 7 Days after the second dose regardless of age This requires a long administration schedule that does not make protection effective until a month after the first administration slowing down access to the vaccine to a greater part of the population and leaving around 18-48 of unprotected vaccinated population until the administration of the second dose The benefits of increasing efficacy after the first dose could be of great importance for Public Health since it would allow a more immediate immunization of the vaccinated population even before the administration of the second dose
A higher and faster immune response to the vaccine could benefit not only the elderly population but also any other type of sub-population to be vaccinated The group of medical staff workers represents a population subject to constant exposure to the virus and for this reason it is considered another priority group to receive the vaccine This group will be exposed to infection during the window of time that passes between the administration of the first and the second dose so the possibility of improving the immune response immediately could have a huge benefit
Over the past 10 years a wide range of pleiotropic effects of selenium have been discovered ranging from antioxidant and anti-inflammatory effects to the production of active thyroid hormone which has drawn attention to the relevance of selenoproteins for health Low selenium level has been associated with an increased risk of mortality poor immune function and cognitive decline An increased level of selenium or selenium supplementation has antiviral effects is essential for the success of male and female reproduction and reduces the risk of autoimmune thyroid diseases Older adults with insufficient selenium intake are at increased risk for a poorer clinical outcome after viral exposure due to a response sub-optimal antiviral response Results from an intervention clinical trials have shown that daily supplementation of older adults with 100 ug of high selenium yeast can raise plasma selenium levels to 150 ug L which is within the proposed target range of selenium status High selenium yeast has demonstrated its safety and clinical efficacy in human supplementation trials
On the other hand the low to moderate zinc deficiency that is highly prevalent in elderly persons mimics many of the features of the immunosenescence of aging Therefore some of the deficits in immune regulation seen among the elderly could be ameliorated or reversed through daily zinc supplementation It has been demonstrated that low zinc status is associated with increased risk of respiratory disease including pneumonia and inflammation Research indicates that zinc supplementation can restore serum zinc levels in some elderly persons with low zinc status Zinc supplementation of 15 per day that may increase immune readiness and favor regulated immune response This protective approach may be particularly important in individuals who may be prone to cytokine-driven immune overreaction during the COVID-19 epidemic
Finally the immunostimulatory effect of beta-glucan is widely known Specifically yeast or fungal beta-1316-glucans interact with specific receptors dectin-1 TLR2 and 6 or CR3 in different cells of the immune system such as macrophages neutrophils granulocytes Natural Killer cells or dendritic cells This interaction stimulates the production of antibodies and primes phagocytosis strengthening defense mechanisms against infections It is important to note that not all beta-glucans have the same mechanisms of action while other linear beta-glucans only bind to Dectin-1 and promote a reduction of phagocytosis and cytokine secretion beta-1316-glucans branched polymers that simultaneously stimulate Dectin-1 and TLR4 receptors stimulate phagocytosis activate innate immunity and prevent or counteract exacerbated immune reactions allergy or inflammation In addition these effects are improved in combination with selenium
ABBC1 is a combination of beta-1316-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for immunity enhancement Due to its high tolerance safety and immediate availability ABBC1 is an ideal candidate for complementary management for geriatric patients with seasonal influenza viruses or COVID-19 or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients including the elderly who are frequently polymedicated and allows adding an additional therapeutic tool in the fight against the pandemic
In this study we propose to determine the benefits of supplementation with ABBC1 in volunteers receiving the influenza vaccine at a first stage and the Covid-19 vaccine when available to study if their immune response to the vaccine improves andor leads to a better clinical outcome
Vaccination against influenza H1N1 is cost-effective and safe Given that the influenza virus shares some common epitopes and mechanisms with the SARS-CoV-2 virus there is the possibility of partial protection for reduce severity related to Covid-19 through flu vaccination The influenza viruses and the SARS-CoV-2 viruses have an evolutionary proximity Since this vaccination is not mandatory for routine clinical practice various countries adopt different policies and vaccination rates differ considerably among them For this reason the WHO in February 2020 published a recommendation on the composition of vaccines against influenza virus for use in the 2020-2021 northern hemisphere influenza season
Under this situation it has been identified that older adults and people suffering from serious chronic conditions such as heart disease lung disease or kidney disease have a higher risk of suffering from severe COVID-19 Older people are twice as likely to have severe COVID-19 This is probably because as people age their immune systems change making it harder to fight off disease and infection and for this reason age is considered a risk factor for the disease
After several months of the global impact of the pandemic specific vaccines for Covid-19 will begin to be available by end 2020 In Spain the Ministry of Health designed a vaccination plan that will begin immediately Specifically in Catalonia this plan foresees classifying the population into various risk groups based on highest priority and immediacy Older adults make up one of the groups that will receive the vaccine as a priority At the same time they represent a population group whose immune response after the administration of other vaccines has been found to be less effective or optimal than in healthy adults under 65 years of age For example the influenza vaccine has an efficacy of 70-90 in the general population while this efficacy is reduced to 17-53 in adults older than 65 years In the same line preliminary results with Covid-19 vaccines observe a better efficacy 90 in groups of people under 55 years of age compared to those over 55 years of age 62 results that suggest that the efficacy could decrease with age
The reduced efficacy of vaccines in the elderly may be because the geriatric population frequently presents immunosenescence or a decline in immune function due to aging but also to a possible poor nutritional status in which it is not achieved to reach an optimal supply of essential oligonutrients for an effective antiviral immune response
Specifically the efficacy data for the BNT162b2 vaccine in people older than 65 years considered a risk population point to a slightly lower efficacy 917 versus 948 in the general population However the results point to less protection after the administration of a single dose of the vaccine 820 efficacy just after the administration of the first dose and 524 between doses 1 and 2 compared to 948 7 Days after the second dose regardless of age This requires a long administration schedule that does not make protection effective until a month after the first administration slowing down access to the vaccine to a greater part of the population and leaving around 18-48 of unprotected vaccinated population until the administration of the second dose The benefits of increasing efficacy after the first dose could be of great importance for Public Health since it would allow a more immediate immunization of the vaccinated population even before the administration of the second dose
A higher and faster immune response to the vaccine could benefit not only the elderly population but also any other type of sub-population to be vaccinated The group of medical staff workers represents a population subject to constant exposure to the virus and for this reason it is considered another priority group to receive the vaccine This group will be exposed to infection during the window of time that passes between the administration of the first and the second dose so the possibility of improving the immune response immediately could have a huge benefit
Over the past 10 years a wide range of pleiotropic effects of selenium have been discovered ranging from antioxidant and anti-inflammatory effects to the production of active thyroid hormone which has drawn attention to the relevance of selenoproteins for health Low selenium level has been associated with an increased risk of mortality poor immune function and cognitive decline An increased level of selenium or selenium supplementation has antiviral effects is essential for the success of male and female reproduction and reduces the risk of autoimmune thyroid diseases Older adults with insufficient selenium intake are at increased risk for a poorer clinical outcome after viral exposure due to a response sub-optimal antiviral response Results from an intervention clinical trials have shown that daily supplementation of older adults with 100 ug of high selenium yeast can raise plasma selenium levels to 150 ug L which is within the proposed target range of selenium status High selenium yeast has demonstrated its safety and clinical efficacy in human supplementation trials
On the other hand the low to moderate zinc deficiency that is highly prevalent in elderly persons mimics many of the features of the immunosenescence of aging Therefore some of the deficits in immune regulation seen among the elderly could be ameliorated or reversed through daily zinc supplementation It has been demonstrated that low zinc status is associated with increased risk of respiratory disease including pneumonia and inflammation Research indicates that zinc supplementation can restore serum zinc levels in some elderly persons with low zinc status Zinc supplementation of 15 per day that may increase immune readiness and favor regulated immune response This protective approach may be particularly important in individuals who may be prone to cytokine-driven immune overreaction during the COVID-19 epidemic
Finally the immunostimulatory effect of beta-glucan is widely known Specifically yeast or fungal beta-1316-glucans interact with specific receptors dectin-1 TLR2 and 6 or CR3 in different cells of the immune system such as macrophages neutrophils granulocytes Natural Killer cells or dendritic cells This interaction stimulates the production of antibodies and primes phagocytosis strengthening defense mechanisms against infections It is important to note that not all beta-glucans have the same mechanisms of action while other linear beta-glucans only bind to Dectin-1 and promote a reduction of phagocytosis and cytokine secretion beta-1316-glucans branched polymers that simultaneously stimulate Dectin-1 and TLR4 receptors stimulate phagocytosis activate innate immunity and prevent or counteract exacerbated immune reactions allergy or inflammation In addition these effects are improved in combination with selenium
ABBC1 is a combination of beta-1316-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for immunity enhancement Due to its high tolerance safety and immediate availability ABBC1 is an ideal candidate for complementary management for geriatric patients with seasonal influenza viruses or COVID-19 or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients including the elderly who are frequently polymedicated and allows adding an additional therapeutic tool in the fight against the pandemic
In this study we propose to determine the benefits of supplementation with ABBC1 in volunteers receiving the influenza vaccine at a first stage and the Covid-19 vaccine when available to study if their immune response to the vaccine improves andor leads to a better clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None