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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by Probiomics Ltd.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Probiomics Ltd

ClinicalTrials.gov Identifier:

NCT00294788

First received: February 21, 2006

Last updated: January 8, 2007

Last verified: January 2007

History of Changes

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Fluvax Drug: PCC® (Lactobacillus fermentum VRI 003)	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Lactobacillus Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Probiomics Ltd:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	300
Study Start Date:	March 2006
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294788

Locations

Australia, New South Wales
Good Health Solutions
Sydney, New South Wales, Australia, 2000

Sponsors and Collaborators

Probiomics Ltd

Investigators

Principal Investigator:

Ronald Penny, DSc, MD, FRACP

Good Health Solutions

More Information

Publications:

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00294788 History of Changes
Other Study ID Numbers:	ProFlu2006, H05/123
Study First Received:	February 21, 2006
Last Updated:	January 8, 2007
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Probiomics Ltd:

Influenza
bioadjuvant
probiotic
HAI

immunity
vaccine
Immune response to influenza vaccine

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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