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Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine

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ClinicalTrials.gov Identifier: NCT04798677
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
AB Biotek

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-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.


Condition or disease Intervention/treatment Phase
Immunity Vaccine Reaction Influenza Covid19 Cytokine Storm Immunologic Deficiency Syndromes Dietary Supplement: ABBC1 Immunoessential Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, randomized, double-blinded, placebo-controlled clinical study. Multicomponent intervention (clinical and nutritional) resulting from the administration of influenza or Covid-19 vaccine and supplementation with ABBC-1.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Ramdomized, double-blinded and placebo-controlled
Primary Purpose: Other
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
Actual Study Start Date : October 29, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Influenza vaccine + intervention with beta-glucan complex and Saccharomyces cerevisiae consortium
Influenza vaccine followed by 30 days of supplementation with a beta-glucan complex and Saccharomyces consortium rich in selenium and zinc
Dietary Supplement: ABBC1 Immunoessential
Powder for dissolution in water, based on a yeast beta-glucan complex and a consortium of Saccharomyces cerevisiae rich in selenium and zinc + excipents. Lemon flavor

Placebo Comparator: Influenza vaccine + placebo
Influenza vaccine followed by 30 days of supplementation with a placebo, similar en aspect, flavor and odour to the intervention product
Dietary Supplement: Placebo
Powder for dissolution in water, excipents. Lemon flavor

Experimental: Covid-19 vaccine + intervention with beta-glucan complex and Saccharomyces cerevisiae consortium
Covid-19 vaccine followed by 35 days of supplementation with a beta-glucan complex and Saccharomyces consortium rich in selenium and zinc
Dietary Supplement: ABBC1 Immunoessential
Powder for dissolution in water, based on a yeast beta-glucan complex and a consortium of Saccharomyces cerevisiae rich in selenium and zinc + excipents. Lemon flavor

Placebo Comparator: Covid-19 vaccine + placebo
Covid-19 vaccine followed by 30 days of supplementation with a placebo, similar en aspect, flavor and odour to the intervention product
Dietary Supplement: Placebo
Powder for dissolution in water, excipents. Lemon flavor




Primary Outcome Measures :
  1. Change in the acute immune response to the influenza vaccine after supplementation (influenza vaccine groups) [ Time Frame: 30 days (Days 1, 7 and 30) ]
    Generation of T-cells (TCD8, TCD3 and TCCD4)

  2. Change in the delayed immune response to the influenza vaccine after supplementation (influenza vaccine groups) [ Time Frame: 30 days (Days 1, 7 and 30) ]
    Generation of influenza-specific antibodies (IgM, IgG influenza A and B)

  3. Change in the acute immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups) [ Time Frame: 35 days (Days 1, 7, 21 and 35) ]
    Generation of T-cells (TCD8, TCD3 and TCCD4)

  4. Change in the delayed immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups) [ Time Frame: 35 days (Days 1, 7, 21 and 35) ]
    Generation of influenza-specific antibodies (IgM, IgG influenza A and B)

  5. Change in blood levels of selenium and zinc [ Time Frame: 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


Secondary Outcome Measures :
  1. Incidence of influenza (only for influenza vaccine groups) [ Time Frame: 30 days ]
    Number of volunteers presenting influenza as measured by clinical diagnostic

  2. Incidence of Covid-19 [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    Number of volunteers presenting Covid-19 as measured by clinical diagnostic and/or PCR or antigen test

  3. Mean Change in the Ordinal Scale WHO R&D Blueprint novel Coronavirus [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.

  4. Number of subjects with fever during the study [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    Variation on body temperature (ºC)

  5. Number of subjects with cough during the study [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    Clinical assessment

  6. Number of subjects with myalgia during the study [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    Clinical assessment

  7. Number of subjects with dyspnea during the study [ Time Frame: 30 days for influenza groups, 35 days for Covid-19 groups ]
    Clinical assessment

  8. Number of subjects with anosmia / ageusia during the study [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    Clinical assessment

  9. Hospital readmission rate during the study and the additional follow-up period [ Time Frame: 60 days ]
    percentage of patients readmitted to the hospital during the study and the addition follow-up period

  10. Changes in blood glucose [ Time Frame: 30 days for influenza groups, 35 days for Covid-19 groups ]
    measured in blood samples

  11. Incidence of adverse effects of the study product [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    reporting of adverse events (if any)

  12. Dietary history [ Time Frame: 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups ]
    Record of the dietary history during the study


Other Outcome Measures:
  1. Blood analysis (Influenza vaccine groups) [ Time Frame: 30 days ]
    Alterations in the blood count and in inflammatory or immune function markers

  2. Blood analysis (Covid-19 vaccine groups) [ Time Frame: 35 days ]
    Alterations in the blood count and in inflammatory or immune function markers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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:
  • Groups:

    • 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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798677


Contacts
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Contact: Julián A. Mateus Rodríguez, MD, PhD +34 634 80 12 17 JAMATEUS.merced@hospitalarias.es
Contact: Mónica Bifano, MD MBIFANO.merced@hospitalarias.es

Locations
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Spain
Hospital Mare de Déu de la Mercè - Germanes Hospitalàries Recruiting
Barcelona, Spain, 08042
Contact: Julián A. Mateus Rodríguez, MD, PhD    +34 634 80 12 17    JAMATEUS.merced@hospitalarias.es   
Contact: Mónica Bifano, MD       MBIFANO.merced@hospitalarias.es   
Sponsors and Collaborators
AB Biotek
Investigators
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Principal Investigator: Julián A. Mateus Rodríguez, MD, PhD Hospital Mare de Deu de la Mercè - Germanes Hositalàries
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: AB Biotek
ClinicalTrials.gov Identifier: NCT04798677    
Other Study ID Numbers: HMDM/ABBC-1/v4
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be available upon request (blood analysis results and clinical assessment outcomes)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Biotek:
Trained immunity
Vaccine adjuvant
Influenza
Covid-19
beta-glucans
Saccharomyces cerevisiae
microbiota
ABBC1
Additional relevant MeSH terms:
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Influenza, Human
Immunologic Deficiency Syndromes
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases