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

Influenza Clinical Trial

Official title:

Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00294788
• Other study ID #: ProFlu2006
• Secondary ID: H05/123
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 21, 2006
• Last updated: January 8, 2007
• Start date: March 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: Probiomics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluvax

Drug:
• PCC® (Lactobacillus fermentum VRI 003)

Locations

Country	Name	City	State
Australia	Good Health Solutions	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Probiomics Ltd

Country where clinical trial is conducted

Australia, 

References & Publications (4)

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. Epub 2005 Feb 14. — View 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. — View 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. — View 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. Epub 2005 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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