Overview

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

Status:
Unknown status
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Probiomics Ltd
Treatments:
Vaccines
Criteria
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