Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
This trial is active, not recruiting.
|Treatments||fluvax, pcc® (lactobacillus fermentum vri 003)|
|Phase||phase 1/phase 2|
|Start date||March 2006|
|End date||January 2007|
|Trial size||300 participants|
|Trial identifier||NCT00294788, H05/123, ProFlu2006|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
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
Male or female participants from 18 years up to 49 years old.
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
|Official title||Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects|
|Principal investigator||Ronald Penny, DSc, MD, FRACP|
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