Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines

Study Overview
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Brief Summary
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This project aims to test the hypothesis that oral consumption of a specific strain of the probiotic bacterium Lactobacillus fermentum (trademarked PCC®) is able to significantly enhance the immune response to a vaccine for influenza.

Official Title
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Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluvax
* Drug: PCC® (Lactobacillus fermentum VRI 003)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons must be adult men and women aged 18-49 years (have not reached 50th birthday). Persons must be able and willing to provide informed consent. Persons must be willing to receive the influenza vaccine (Fluvax®) given as an intramuscular injection. Persons must be willing to consume one gelatin capsule per day containing either probiotic bacteria or placebo (inactive substance) for the duration (42 days) of the study. Persons must be willing to provide blood specimens, each of 10 ml, collected by venepuncture. Persons must be willing to notify study personnel of a range of health effects by questionnaire. Exclusion Criteria: Any health condition for which the influenza vaccine is not recommended including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency diseases (including HIV infection) or on-going immunosuppressive therapy. Currently pregnant; nursing mothers; or planning a pregnancy within one month of vaccination. Allergy to latex, egg, or egg protein, or the antibiotics neomycin or polymyxin. A prior serious reaction to a vaccine, or have had Guillain-Barre syndrome. Received an influenza vaccine in the past. Received any other vaccine within one month prior to enrolment Are participating in another research study involving any study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fluvax|nan|
|Drug: PCC® (Lactobacillus fermentum VRI 003)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage enhancement of the immune response to Fluvax vaccine by PCC® compared to placebo as measured by hemagglutination inhibition (HAI) titre in the serum of subjects 4 weeks after vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in T cell cytokine expression; Decrease in incidence of respiratory tract illness, an improvement in general intestinal health, and a reduction in the severity of adverse side effects of the injection |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, bioadjuvant, probiotic, HAI, immunity, vaccine, Immune response to influenza vaccine