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

NCT04798677 | Completed DMC

• 1 other identifier: HMDM/ABBC-1/v4
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunity; Vaccine Reaction; Influenza; Covid19; Cytokine Storm; Immunologic Deficiency Syndromes

Keywords

Trained immunity; Vaccine adjuvant; Influenza; Covid-19; beta-glucans; Saccharomyces cerevisiae; microbiota; ABBC1

Outcome Measures

Primary Outcomes (5)

• Change in the acute immune response to the influenza vaccine after supplementation (influenza vaccine groups)

  Generation of T-cells (TCD8, TCD3 and TCCD4)

  30 days (Days 1, 7 and 30)

• Change in the delayed immune response to the influenza vaccine after supplementation (influenza vaccine groups)

  Generation of influenza-specific antibodies (IgM, IgG influenza A and B)

  30 days (Days 1, 7 and 30)

• Change in the acute immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups)

  Generation of T-cells (TCD8, TCD3 and TCCD4)

  35 days (Days 1, 7, 21 and 35)

• Change in the delayed immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups)

  Generation of influenza-specific antibodies (IgM, IgG influenza A and B)

  35 days (Days 1, 7, 21 and 35)

• Change in blood levels of selenium and zinc

  Variation of selenium and zinc levels measured in plasma

  30 days (Days 1, 7 and 30) for influenza vaccine groups. 35 days (Days 1, 7, 21 and 35) for Covi-19 groups.

Secondary Outcomes (12)

• Incidence of influenza (only for influenza vaccine groups)

  30 days

• Incidence of Covid-19

  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 cough during the study

  30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups

Other Outcomes (2)

• Blood analysis (Influenza vaccine groups)

  30 days

• Blood analysis (Covid-19 vaccine groups)

  35 days

Study Arms (4)

Influenza vaccine + intervention with beta-glucan complex and Saccharomyces cerevisiae consortium

EXPERIMENTAL

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

Influenza vaccine + placebo

PLACEBO COMPARATOR

Influenza vaccine followed by 30 days of supplementation with a placebo, similar en aspect, flavor and odour to the intervention product

Dietary Supplement: Placebo

Covid-19 vaccine + intervention with beta-glucan complex and Saccharomyces cerevisiae consortium

EXPERIMENTAL

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

Covid-19 vaccine + placebo

PLACEBO COMPARATOR

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

Interventions

ABBC1 Immunoessential DIETARY_SUPPLEMENT

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

Covid-19 vaccine + intervention with beta-glucan complex and Saccharomyces cerevisiae consortium; Influenza vaccine + intervention with beta-glucan complex and Saccharomyces cerevisiae consortium

Placebo DIETARY_SUPPLEMENT

Powder for dissolution in water, excipents. Lemon flavor

Covid-19 vaccine + placebo; Influenza vaccine + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AB Biotek: lead

Study Sites (1)

Hospital Mare de Déu de la Mercè - Germanes Hospitalàries

Barcelona, 08042, Spain

Location

Related Publications (21)

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MeSH Terms

Conditions

Influenza, Human; COVID-19; Cytokine Release Syndrome; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Immune System Diseases

Study Officials

• Julián A. Mateus Rodríguez, MD, PhD

  Hospital Mare de Deu de la Mercè - Germanes Hositalàries

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Ramdomized, double-blinded and placebo-controlled
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 15, 2021
• Study Start: October 29, 2020
• Primary Completion: June 10, 2021
• Study Completion: September 24, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)