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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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Probiomics Ltd.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294788
First Posted: February 22, 2006
Last Update Posted: January 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Probiomics Ltd
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00294788     History of Changes
Other Study ID Numbers: ProFlu2006
H05/123
First Submitted: February 21, 2006
First Posted: February 22, 2006
Last Update Posted: January 9, 2007
Last Verified: January 2007

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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