Clinical trial NCT00294788: Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
Official title: Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza
bioadjuvant
probiotic
HAI
immunity
vaccine
Immune response to influenza vaccine
Lead sponsor: Probiomics Ltd
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Good Health Solutions
state: New South Wales
Study officials:
affiliation: Good Health Solutions
name: Ronald Penny, DSc, MD, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamadzadeh M, Olson S, Kalina WV, Ruthel G, Demmin GL, Warfield KL, Bavari S, Klaenhammer TR. Lactobacilli activate human dendritic cells that skew T cells toward T helper 1 polarization. Proc Natl Acad Sci U S A. 2005 Feb 22;102(8):2880-5. doi: 10.1073/pnas.0500098102. Epub 2005 Feb 14.
citation: Prescott SL, Dunstan JA, Hale J, Breckler L, Lehmann H, Weston S, Richmond P. Clinical effects of probiotics are associated with increased interferon-gamma responses in very young children with atopic dermatitis. Clin Exp Allergy. 2005 Dec;35(12):1557-64. doi: 10.1111/j.1365-2222.2005.02376.x.
citation: Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. doi: 10.1136/adc.2004.060673. Epub 2005 Apr 29.
citation: Qi H, Denning TL, Soong L. Differential induction of interleukin-10 and interleukin-12 in dendritic cells by microbial toll-like receptor activators and skewing of T-cell cytokine profiles. Infect Immun. 2003 Jun;71(6):3337-42. doi: 10.1128/IAI.71.6.3337-3342.2003.