Trial | NCT00294788  Report issue

Title

Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    300
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.
Study Started
Mar 31
2006
Study Completion
Jan 31
2007
Last Update
Jan 09
2007
Estimate

Biological Fluvax

Drug PCC® (Lactobacillus fermentum VRI 003)

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
No Results Posted