Influenza Vaccine Clinical Trial
— FLUVAC21Official title:
Efficacy and Safety of a Multistrain Probiotic Formula to Boost the Immune Response to Influenza Virus Vaccination
Verified date | July 2022 |
Source | AB Biotics, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | May 31, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | 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 Exclusion criteria during the study: - Withdrawal from the study as per study investigator criteria, in case that study procedures are not followed by the participant - In case of adverse event that prevents them from following study procedures or complying with the treatments under study. - Failure to comply with study procedures: Complete less than 70% of the days in the patient's diary and/or take less than 80% of the days of the study products. - Receive any of the unauthorized treatments indicated in the selection criteria, with the exception of antibiotics that will be allowed under medical prescription. |
Country | Name | City | State |
---|---|---|---|
Spain | FIBAO- Fundación para la Investigación Biosanitaria de Andalucia Oriental | Granada | |
Spain | Hospital General de Granollers | Granollers | Barcelona |
Spain | Hospital Parc Tauli | Sabadell | Barcelona |
Spain | IDIAP Jordi Gol-Centro de Atención Primaria La Mina | Sant Adrià De Besòs | Barcelona |
Spain | Mutua de Terrassa | Terrassa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
AB Biotics, SA |
Spain,
Darbandi A, Asadi A, Ghanavati R, Afifirad R, Darb Emamie A, Kakanj M, Talebi M. The effect of probiotics on respiratory tract infection with special emphasis on COVID-19: Systemic review 2010-20. Int J Infect Dis. 2021 Apr;105:91-104. doi: 10.1016/j.ijid — View Citation
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Yeh TL, Shih PC, Liu SJ, Lin CH, Liu JM, Lei WT, Lin CY. The influence of prebiotic or probiotic supplementation on antibody titers after influenza vaccination: a systematic review and meta-analysis of randomized controlled trials. Drug Des Devel Ther. 20 — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IgG antibodies against vaccine influenza antigens | Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28 | 4 weeks (day 1 and day 28) | |
Secondary | IgG antibodies against vaccine influenza antigens | Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 56 | 8 weeks (day 1 and day 56) | |
Secondary | IgM antibodies against vaccine influenza antigens | Titer of specific total IgM antibodies against vaccine influenza A and B antigens at day 28 and 56 | 8 weeks (day 1 and day 56) | |
Secondary | Seroconversion | Percentage of patients with seroconversion (defined as 4 fold change in influenza IgG antibodies concentration compared to baseline) at day 28 and 56 | 8 weeks (day 1,day 28 and 56) | |
Secondary | Incidence of influenza like infections (ILI) | Cumulative incidence of influenza like infection (ILI), according to the European Diseases Prevention and Control Center (ECDC) criteria | 16 weeks (day 1, day 56) | |
Secondary | Incidence of any other respiratory infections (including COVID-19) | Cumulative incidence of any other respiratory infections | 16 weeks (day 1, day 56) | |
Secondary | Incidence of fever | Cumulative number of days with fever (> 37.5ÂșC) | 16 weeks (day 1, day 56) | |
Secondary | Use of analgesics and antibiotics | Cumulative number of days using analgesics and antibiotics | 16 weeks (day 1, day 56) | |
Secondary | Duration of vaccine-related symptoms: injection-site pain, swelling, redness | Duration (in days) of symptoms after receiving the flu vaccine. | 1 week (day 1, day 7) | |
Secondary | Severity of vaccine-related symptoms: injection-site pain, swelling, redness | Severity of symptoms after receiving the flu vaccine. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe | 1 week (day 1, day 7) | |
Secondary | Gastrointestinal symptoms | Gastrointestinal manifestations documented through questionnaire in participants diary. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe. | 4 weeks (day 1, day 28) | |
Secondary | Adverse events | Frequency of adverse events reported in medical visits or patient diary | 8 weeks (day 56) | |
Secondary | Albumin | Albumin concentration in blood | 4 weeks (day 1, day 28) | |
Secondary | Alkaline phosphatase (ALP) | Alkaline phosphatase (ALP) concentration in blood | 4 weeks (day 1, day 28) | |
Secondary | Gamma-glutamil transpeptidase (GGT) | Gamma-glutamil transpeptidase (GGT) concentration in blood | 4 weeks (day 1, day 28) | |
Secondary | Aspartate aminotransferase (GOT) | Aspartate aminotransferase (AST) concentration in blood | 4 weeks (day 1, day 28) | |
Secondary | Alanine aminotransferase (AST) | Aspartate aminotransferase (AST) concentration in blood | 4 weeks (day 1, day 28) | |
Secondary | Basic hemogram | Blood cell count | 4 weeks (day 1, day 28) |
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