InfluenzaLUPINNCT06103994
Study to Assess the Effect of Multistrain Probiotic on the Immune Response to the Influenza Vaccination
A study testing Multistrain probiotic in people with Influenza, run by The Archer-Daniels-Midland Company at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Multistrain probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 27 Oct 2023to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Have been informed and have given written consent for the use of their data in accordance with local regulations before study inclusion.
- If sexually active, commitment to use contraception methods.
- Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
Who cannot join
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
- Asymptomatic chronic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this trial) in the opinion of the investigator.
- Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
- Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza infection (e.g., cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
- 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).
Show all 24Show fewer
- 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.
- Smoking individuals.
- Pregnant female, or individual who is planning on becoming pregnant during the course of the study.
- Breastfeeding females.
- Consumption of probiotic food supplements or use of antibiotics 1 month prior to study start.
- Planned significant change in dietary or exercise practices during the course of the study.
- Planned travel for more than 14 days during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blinded, Placebo-controlled, Parallel Group Study, to Assess the Effect of Multistrain Probiotic on the Immune Response to the Influenza Vaccination
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
- Being tested
- Multistrain probiotic, Placebo
- Keywords
- microbiome, probiotic, immune system, vaccine, influenza, flu
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multistrain probioticDietary supplement
Multistrain Probiotic
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Multistrain probiotic Receives: Dietary Supplement: Multistrain probiotic |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: V2 (3 weeks), V3 (6 weeks)
Secondary outcomes (11)
Change in seroprotection rate (as measured by HAI tests)
Change in seroprotection rate (as measured by HAI tests) between verum and placebo groups for each of 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine from V2 to V3. Seroprotection is defined as the proportion (percentage) of volunteers achieving an influenza antibody titer ≥1:40 by the HAI test. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
Change in seroconversion rate (as measured by HAI tests)
Change in seroconversion rate (as measured by HAI tests) between verum and placebo groups for each of 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine from V2 to V3. Seroconversion is defined as the proportion of subjects with a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or subjects with a pre-vaccination HAI titer >1:10 and at least a 4-fold increase at day 42. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
Change in geometric mean neutralizing antibody (nAb) titers (as measured by microneutralization assays)
Change in geometric mean neutralizing antibody (nAb) titers specific for each of 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine , as measured by a microneutralization assay from V2 to V3. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
Change in seroprotection rate (as measured by nAb titers in a microneutralization assay)
Change in seroprotection rate (as measured by nAb titers) specific for each of 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine, as measured by a microneutralization assay from V2 to V3. Seroprotection is defined as the proportion (percentage) of volunteers achieving an influenza nAb titer ≥1:40 in MN test. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
Change in seroconversion rate (as measured by nAb titers in a microneutralization assay)
Change in seroconversion rate (as measured by nAb titers) specific for each of 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine, as measured by a microneutralization assay from V2 to V3. Seroconversion is defined as the proportion of subjects with a pre-vaccination nAb titer <1:10 and a post-vaccination nAb titer ≥1:40 or subjects with a pre-vaccination MN titer >1:10 and at least a 4-fold increase at day 42. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
Change in the adaptive immune response
Change in the adaptive immune response, assessed by change in total plasma, strain A and B specific IgA, IgM, IgG from V2 to V3 between intervention and placebo. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
Change in innate immune response
Change in innate immune responses assessed by difference in plasma concentrations of interferon-gamma, TNF-alpha, IL-2, IL-10 from V2 to V3 between intervention and placebo. Higher values mean better immune response.
Measured: V2 (3 weeks), V3 (6 weeks)
VAPI (Vaccinees' Perception of Injection) Questionnaire
VAPI (Vaccinees' Perception of Injection) Questionnaire difference at V3 between intervention and placebo. Higher values mean worse perception of the vaccine.
Measured: V3 (6 weeks)
Change in GSRS (Gastrointestinal Symptom Rating Scale) questionnaire scoring
Change in GSRS (Gastrointestinal Symptom Rating Scale) questionnaire scoring from baseline to V2,V2 to V3 and baseline to V3 between intervention and placebo. Higher values mean more troublesome symptoms
Measured: V1 (Baseline), V2 (3 weeks), V3 (6 weeks)
Change in stool microbiome composition
Change in stool microbiome composition between verum and placebo between V1 and V3 in 40% of the cohort (40% of each study arm).
Measured: V1 (Baseline), V3 (6 weeks)
Adverse Events
The number of adverse events (AE)/serious adverse events (SAE) (related to the study IP) occurring during the study compared to placebo.
Measured: V3 (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start27 Oct 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NEXT CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103994
- Sponsor's protocol ID
- CTB2022TN107
- Acronym
- LUPIN
- Status last verified
- Apr 2024
- First submitted
- 23 Oct 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blinded, Placebo-controlled, Parallel Group Study, to Assess the Effect of Multistrain Probiotic on the Immune Response to the Influenza Vaccination
- ClinicalTrials.gov ID
- NCT06103994
- Acronym / sponsor ID
- LUPIN / CTB2022TN107
- Conditions
- Influenza
- Keywords
- microbiome, probiotic, immune system, vaccine, influenza, flu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- NEXT CRO
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, triple-blinded, placebo-controlled, parallel group study, to assess the effect of multistrain probiotic on the immune response to the Influenza vaccination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Multistrain probioticMultistrain probiotic |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Have been informed and have given written consent for the use of their data in accordance with local regulations before study inclusion.
- If sexually active, commitment to use contraception methods.
Key exclusion criteria (24 listed)
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
- Asymptomatic chronic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this trial) in the opinion of the investigator.
- Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
- Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza infection (e.g., cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
- Participation in research involving a drug, biologic or device within 45 days before planned date of V2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multistrain probioticMultistrain Probiotic | Dietary supplement | Intervention |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition [HAI] tests)
Time frame: V2 (3 weeks), V3 (6 weeks)
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.
11 secondary outcomes
Change in seroprotection rate (as measured by HAI tests)
Time frame: V2 (3 weeks), V3 (6 weeks)
Change in seroconversion rate (as measured by HAI tests)
Time frame: V2 (3 weeks), V3 (6 weeks)
Change in geometric mean neutralizing antibody (nAb) titers (as measured by microneutralization assays)
Time frame: V2 (3 weeks), V3 (6 weeks)
Change in seroprotection rate (as measured by nAb titers in a microneutralization assay)
Time frame: V2 (3 weeks), V3 (6 weeks)
Change in seroconversion rate (as measured by nAb titers in a microneutralization assay)
Time frame: V2 (3 weeks), V3 (6 weeks)
Change in the adaptive immune response
Time frame: V2 (3 weeks), V3 (6 weeks)
Change in innate immune response
Time frame: V2 (3 weeks), V3 (6 weeks)
VAPI (Vaccinees' Perception of Injection) Questionnaire
Time frame: V3 (6 weeks)
Change in GSRS (Gastrointestinal Symptom Rating Scale) questionnaire scoring
Time frame: V1 (Baseline), V2 (3 weeks), V3 (6 weeks)
Change in stool microbiome composition
Time frame: V1 (Baseline), V3 (6 weeks)
Adverse Events
Time frame: V3 (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multistrain probiotic in people with Influenza, run by The Archer-Daniels-Midland Company at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition [HAI] tests) (time frame: V2 (3 weeks), V3 (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.