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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-01-31

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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Fluvax

Intervention Type BIOLOGICAL

PCC® (Lactobacillus fermentum VRI 003)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes