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

Probiomics

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Influenza

Treatments

Drug: PCC® (Lactobacillus fermentum VRI 003)

Biological: Fluvax

Study type

Interventional

Funder types

Industry

Identifiers

NCT00294788

H05/123

ProFlu2006

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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