Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
Phase 1
- Conditions
- Influenza
- Registration Number
- NCT00294788
- Lead Sponsor
- Probiomics Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Good Health Solutions
🇦🇺Sydney, New South Wales, Australia