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

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Fluvax

PCC® (Lactobacillus fermentum VRI 003)

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, bioadjuvant, probiotic, HAI, immunity, vaccine, Immune response to influenza vaccine

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Good Health Solutions

Outcomes

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

Full Information

NCT ID

NCT00294788

First Posted

February 21, 2006

Last Updated

January 8, 2007

Sponsor

Probiomics Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00294788

Brief Title

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

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Probiomics Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, bioadjuvant, probiotic, HAI, immunity, vaccine, Immune response to influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Fluvax

Intervention Type

Drug

Intervention Name(s)

PCC® (Lactobacillus fermentum VRI 003)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Penny, DSc, MD, FRACP

Organizational Affiliation

Good Health Solutions

Official's Role

Principal Investigator

Facility Information:

Facility Name

Good Health Solutions

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2000

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

15710900

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.

Results Reference

background

PubMed Identifier

16393321

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.

Results Reference

background

PubMed Identifier

15863468

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.

Results Reference

background

PubMed Identifier

12761116

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.

Results Reference

background

Influenza

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial