Influenza Vaccine
Conditions
Keywords
influenza vaccination, probiotic
Brief summary
Randomized clinical trial to determine whether a probiotic formulation containing 4 probiotic strains which belong to Lactiplantibacillus plantarum and Pediococcus acidilactici species can boost the immune response to influenza vaccination evaluated at 4 weeks in a population between 50 and 80 years of age. Secondary outcomes comprise evaluation of immune response at 8 weeks after vaccination, percentage of patients with seroconversion, incidence and duration of influenza-like infections and respiratory infections throughout a 4-month period and safety.
Detailed description
Double blind, randomized, placebo-controlled clinical trial to determine whether supplementation with a probiotic formulation containing 4 probiotic strains (L. plantarum CECT 30292, CECT7484, CECT7485 and P. acidilactici CECT7483) can improve immune response to seasonal influenza vaccination. Subjects with age comprised between 50 and 80 years who meet inclusion and exclusion criteria will be randomized 1:1 to one of the following study groups: one will receive probiotic formulation for 28 days (1 capsule/day) and the other will receive placebo, starting the same day of the influenza vaccination. Main study outcome will be immune response at 4 weeks after vaccination, which will be determined by analysis of specific IgG antibodies in serum against influenza A and B. Secondary outcomes comprise serum titers of specific IgG at 8 weeks after vaccination, percentage of patients with seroconversion at 4 and 8 weeks, evaluation of influenza-like infections or respiratory infections throughout a 4-month period and adverse events.
Interventions
DIETARY_SUPPLEMENTFood Supplement
Probiotic multistrain formulation containing Lactiplantibacillus plantarum CECT30292, CECT7484, CECT7485 and P. acidilactici CECT7483 for 28 days, starting the same day of influenza vaccination
DIETARY_SUPPLEMENTPlacebo
One maltodextrin-containing capsule/day for 28 days, starting the same day of influenza vaccination
Sponsors
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both placebo and active product will be provided in identical packaging.
Intervention model description
Double blind, randomized controlled trial in 140 subjects 50-80 years old receiving influenza vaccination, who will be allocated to receive either an experimental product containing multi-strain probiotic formula or placebo for 28 days
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects 50 - 80 years old receiving seasonal Influenza vaccine in season 2021-2022 * Body mass index (BMI) 18.5-34.9 kg/m2 * Willing to provide informed consent * Able to follow study procedures, according to the criteria of study investigator
Exclusion criteria
* Hypersensitivity to any of the components of influenza vaccine * Previous influenza infection in the same season (from 01/09/2021) * Having received influenza vaccination in the previous season less than 9 months before study entry (from 01/01/2021) * Having received another vaccine -different from COVID19 vaccine- up to 1 month before study inclusion or planning to receive it 1 month after study inclusion * Active infection at the moment of study entry as diagnosed by study physician * History of severe allergic reactions (food and non-food), including severe asthma. * Receiving immunosuppressant therapy, displaying neutropenia, lymphopenia, AIDS, immunoglobulin deficiency, active oncological disease. * Daily ingestion of any food complement or food added with probiotics (including Actimel o similar products) 2 weeks before inclusion in the study * Acute pancreatitis, short bowel syndrome or active inflammatory bowel disease * Diagnosed from other pathologies that according to study physician may compromise the immunological function of the individual (such as immunodeficiencies, lupus, multiple sclerosis, among others) * Having received antibiotic treatment in the previous month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgG antibodies against vaccine influenza antigens | 4 weeks (day 1 and day 28) | Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IgM antibodies against vaccine influenza antigens | 8 weeks (day 1 and day 56) | Titer of specific total IgM antibodies against vaccine influenza A and B antigens at day 28 and 56 |
| Seroconversion | 8 weeks (day 1,day 28 and 56) | Percentage of patients with seroconversion (defined as 4 fold change in influenza IgG antibodies concentration compared to baseline) at day 28 and 56 |
| Incidence of influenza like infections (ILI) | 16 weeks (day 1, day 56) | Cumulative incidence of influenza like infection (ILI), according to the European Diseases Prevention and Control Center (ECDC) criteria |
| Incidence of any other respiratory infections (including COVID-19) | 16 weeks (day 1, day 56) | Cumulative incidence of any other respiratory infections |
| Incidence of fever | 16 weeks (day 1, day 56) | Cumulative number of days with fever (\> 37.5ºC) |
| Use of analgesics and antibiotics | 16 weeks (day 1, day 56) | Cumulative number of days using analgesics and antibiotics |
| Duration of vaccine-related symptoms: injection-site pain, swelling, redness | 1 week (day 1, day 7) | Duration (in days) of symptoms after receiving the flu vaccine. |
| Severity of vaccine-related symptoms: injection-site pain, swelling, redness | 1 week (day 1, day 7) | Severity of symptoms after receiving the flu vaccine. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe |
| IgG antibodies against vaccine influenza antigens | 8 weeks (day 1 and day 56) | Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 56 |
| Adverse events | 8 weeks (day 56) | Frequency of adverse events reported in medical visits or patient diary |
| Albumin | 4 weeks (day 1, day 28) | Albumin concentration in blood |
| Alkaline phosphatase (ALP) | 4 weeks (day 1, day 28) | Alkaline phosphatase (ALP) concentration in blood |
| Gamma-glutamil transpeptidase (GGT) | 4 weeks (day 1, day 28) | Gamma-glutamil transpeptidase (GGT) concentration in blood |
| Aspartate aminotransferase (GOT) | 4 weeks (day 1, day 28) | Aspartate aminotransferase (AST) concentration in blood |
| Alanine aminotransferase (AST) | 4 weeks (day 1, day 28) | Aspartate aminotransferase (AST) concentration in blood |
| Basic hemogram | 4 weeks (day 1, day 28) | Blood cell count |
| Gastrointestinal symptoms | 4 weeks (day 1, day 28) | Gastrointestinal manifestations documented through questionnaire in participants diary. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe. |
Countries
Spain
Outcome results
None listed