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NCT05074303: M-Unity

Beta-glucan and Immune Response to Influenza Vaccine

Completed Phase 2 Results posted Last updated 6 November 2025
What this trial tests

Phase 2 trial testing Influenza Vaccine in Healthy Aging in 78 participants. Completed in 28 August 2024.

Timeline
18 July 2022
Primary endpoint
1 March 2024
28 August 2024

Quick facts

Lead sponsorUniversity of Florida
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment78
Start date18 July 2022
Primary completion1 March 2024
Estimated completion28 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Florida

Who can join

Adults 50 to 100, any sex, with Healthy Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Antibody Titer Primary · 42 days (mean of Day -14 and 0 compared to Day 28)

Change in influenza-specific antibody influenza A titer to the influenza vaccine after beta-glucan supplementation. Titer from 0 to 1024; higher titer indicates stronger immune response.

Baseline (Mean of Day -14 and Day 0)
GroupValue95% CI
Beta-glucan127± 105
Placebo143± 172
Intervention (Day 28)
GroupValue95% CI
Beta-glucan241± 272
Placebo160± 165
Inflammatory Cytokine Profile Secondary · 28 days (Day 0, Day 1, and Day 28)

Change in IFN-γ

Day 0
GroupValue95% CI
Beta-glucan2.3± 0.1
Placebo2.4± 0.4
Day 1
GroupValue95% CI
Beta-glucan8.2± 1.7
Placebo8.3± 2.9
Day 28
GroupValue95% CI
Beta-glucan3.3± 0.5
Placebo2.3± 0.4
Incidence of Influenza and Covid-19 Secondary · 28 days

Self-reported incidence of influenza and Covid-19

GroupValue95% CI
Beta-glucan0
Placebo0
Fever Secondary · 28 days

Number of subjects with self-reported fever

GroupValue95% CI
Beta-glucan1
Placebo1
Cold and Flu Symptoms Secondary · 28 days

Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).

GroupValue95% CI
Beta-glucan0.92± 0.07
Placebo0.70± 0.06

Sponsor's own description

This trial in healthy adults will determine the effects of beta-glucan, a dietary fiber supplement isolated from baker's yeast, on immune response to the influenza vaccine.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Yeast Beta-Glucan Enhances Antibody Response Following Influenza Vaccination - A Double-Blind, Randomized, Placebo-Controlled Pilot Trial.
    Moreno ML, Nieves CJ, Hebert K, Vivas CA, et al · · 2025 · cited 2× · PMID 40746014 · DOI 10.1080/19390211.2025.2539876

Verify or expand the search:

Other trials of Influenza Vaccine

Trials testing the same drug.

Other recruiting trials for Healthy Aging

Currently open trials in the same condition.

Other University of Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05074303.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing