Study to Assess the Effect of Multistrain Probiotic on the Immune Response to the Influenza Vaccination

NCT06103994 | Completed

• 1 other identifier: CTB2022TN107
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, triple-blinded, placebo-controlled, parallel group study, to assess the effect of multistrain probiotic on the immune response to the Influenza vaccination

Conditions

Influenza

Keywords

microbiome; probiotic; immune system; vaccine; influenza; flu

Outcome Measures

Primary Outcomes (1)

• Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition [HAI] tests)

  Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition \[HAI\] tests) specific for each of the 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine, between intervention and placebo from V2 to V3. Higher values mean better immune response.

  V2 (3 weeks), V3 (6 weeks)

Secondary Outcomes (11)

• Change in seroprotection rate (as measured by HAI tests)

  V2 (3 weeks), V3 (6 weeks)

• Change in seroconversion rate (as measured by HAI tests)

  V2 (3 weeks), V3 (6 weeks)

• Change in geometric mean neutralizing antibody (nAb) titers (as measured by microneutralization assays)

  V2 (3 weeks), V3 (6 weeks)

• Change in seroprotection rate (as measured by nAb titers in a microneutralization assay)

  V2 (3 weeks), V3 (6 weeks)

• Change in seroconversion rate (as measured by nAb titers in a microneutralization assay)

  V2 (3 weeks), V3 (6 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

Multistrain probiotic

Dietary Supplement: Multistrain probiotic

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Multistrain probiotic DIETARY_SUPPLEMENT

Multistrain Probiotic

Intervention

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female adults aged 18-65 years
• According to the clinical judgment of the physician, appropriate to be vaccinated against the influenza virus.
• Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AE/SAE.
• If sexually active, commitment to use contraception methods.
• Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

You may not qualify if:

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
• Participation in research involving a drug, biologic or device within 45 days before planned date of V2.
• History of a serious reaction to a prior influenza vaccination (any influenza vaccine, not exclusive to INFLUVAC TETRA).
• Hypersensitivity or allergy to INFLUVAC TETRA, its active substance, or components e.g. eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, gentamicin, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, water for injections.
• Hypersensitivity or allergy to any of the ingredients of the investigational product (IP) or placebo.
• Individuals with thrombocytopenia, any coagulation disorder or who are pharmacologically anticoagulated.
• History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
• Receipt of ANY non-influenza vaccine (e.g., hepatitis B vaccine, tetanus vaccine) in the 4 weeks preceding the trial vaccination, and ANY influenza vaccine within 6 months preceding the trial vaccination, or already received the 2023-2024 influenza vaccine (any brand).
• Planned receipt of any vaccine (other than the INFLUVAC TETRA at V2) during the study
• Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
• Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine or during the trial.
• Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C).
• Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
• Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• NEXT CRO: collaborator

Study Sites (1)

Leof. Mesogeion 264,

Athens, Cholargos, 155 62, Greece

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: October 27, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: April 10, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)