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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014