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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in the delayed immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups)
研究概览
简要总结
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-1,3/1,6-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity. ABBC1 includes repurposed synergistic yeast-based ingredients: a unique ß-1,3/1,6-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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Ramdomized, double-blinded and placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COMMON CRITERIA:
- •Subjects with the ability to take the study product orally
- •Ability to understand the study, the information about the symptoms and to comply with the treatment shots.
- •Subject or legal guardian / representative willing to give informed consent in writing.
- •INFLUENZA VACCINE GROUPS:
- •Subjects who require hospitalization or external follow-up (outpatients or PADES)
- •Subjects over 60 years old who will receive the influenza vaccine
- •COVID-19 VACCINE GROUPS
- •Subjects from long-stay centres attached to the Hospital Mare de Déu de la Mercè, and meet the following inclusion criteria:
- •Subjects over 18 years of age who receive the Covid-19 vaccine, in a stable clinical situation, at the discretion of the researcher, or
- •Healthcare workers of the study centers, over 18 years of age who receive the Covid-19 vaccine
- •Availability to attend clinical visits.
排除标准
- •COMMON CRITERIA:
- •Need for assisted ventilation that makes oral consumption of the product under study impossible
- •History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
- •History or evidence of any medical conditions or medication use that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
- •Subjects in situation of last days
- •COVID-19 VACCINE GROUPS:
- •Subjects in whom the Covid-19 vaccine is contraindicated.
- •A history of frailty or comorbidity that indicates a situation of clinical instability.
- •History or evidence of any medical conditions or drug use that, in the opinion of the principal investigator, could affect the safety of subjects or interfere with study evaluations.
结局指标
主要结局
Change in the delayed immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups)
时间窗: 35 days (Days 1, 7, 21 and 35)
Generation of influenza-specific antibodies (IgM, IgG influenza A and B)
Change in the acute immune response to the influenza vaccine after supplementation (influenza vaccine groups)
时间窗: 30 days (Days 1, 7 and 30)
Generation of T-cells (TCD8, TCD3 and TCCD4)
Change in blood levels of selenium and zinc
时间窗: 30 days (Days 1, 7 and 30) for influenza vaccine groups. 35 days (Days 1, 7, 21 and 35) for Covi-19 groups.
Variation of selenium and zinc levels measured in plasma
Change in the acute immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups)
时间窗: 35 days (Days 1, 7, 21 and 35)
Generation of T-cells (TCD8, TCD3 and TCCD4)
Change in the delayed immune response to the influenza vaccine after supplementation (influenza vaccine groups)
时间窗: 30 days (Days 1, 7 and 30)
Generation of influenza-specific antibodies (IgM, IgG influenza A and B)
次要结局
- Incidence of Covid-19(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Changes in blood glucose(30 days for influenza groups, 35 days for Covid-19 groups)
- Incidence of influenza (only for influenza vaccine groups)(30 days)
- Hospital readmission rate during the study and the additional follow-up period(60 days)
- Number of subjects with anosmia / ageusia during the study(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Dietary history(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Number of subjects with cough during the study(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Number of subjects with myalgia during the study(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Mean Change in the Ordinal Scale WHO R&D Blueprint novel Coronavirus(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Number of subjects with fever during the study(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)
- Number of subjects with dyspnea during the study(30 days for influenza groups, 35 days for Covid-19 groups)
- Incidence of adverse effects of the study product(30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups)