Influenza
Conditions
Keywords
Influenza, bioadjuvant, probiotic, HAI, immunity, vaccine, Immune response to influenza vaccine
Brief summary
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.
Interventions
BIOLOGICALFluvax
DRUGPCC® (Lactobacillus fermentum VRI 003)
Sponsors
Probiomics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
Australia
Outcome results
None listed