Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Amerifit Brands Inc
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00620412
First received: February 11, 2008
Last updated: January 16, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine whether the food supplement called Lactobacillus rhamnosus GG (LGG) may help boost the effectiveness of the nasal flu vaccine. Preliminary data from several studies of healthy volunteers suggest that LGG boosts the immune response to vaccines. Fifty-two subjects will be recruited into the study, all will receive the nasal flu vaccine. Twenty-six will receive capsules that contain LGG, 26 will receive placebo capsules. Blood and nasal specimens will be collected weekly for four weeks and at eight weeks to evaluate the initial mucosal and systemic immune response to the immunization. This study will provide preliminary data on whether the immune response of healthy adults to the nasal influenza vaccine can be boosted by LGG.


Condition Intervention Phase
Healthy
Dietary Supplement: Lactobacillus rhamnosus
Dietary Supplement: placebo control
Biological: Influenza Virus Vaccine Live, Intranasal
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lactobacillus GG to Enhance the Immunogenicity of Influenza Vaccine in Healthy Adults - Proof of Concept Study

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • To measure anti-influenza systemic and mucosal antibody responses 4 weeks after administration of influenza vaccine (LAIV) to healthy subjects aged 18-49 and to compare responses in subjects receiving Lactobacillus GG (LGG) versus placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess time course of antibody response after administration of influenza vaccine (LAIV) and to compare responses in subjects receiving LGG versus placebo [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment Dietary Supplement: Lactobacillus rhamnosus
2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10^10 LGG organisms.
Other Name: Culturelle
Biological: Influenza Virus Vaccine Live, Intranasal
intranasal spray, 0.1ml per nostril, one time dose
Other Name: FluMist
Placebo Comparator: placebo Dietary Supplement: placebo control
2 capsules by mouth twice a day for 28 days
Biological: Influenza Virus Vaccine Live, Intranasal
intranasal spray, 0.1ml per nostril, one time dose
Other Name: FluMist

  Eligibility

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

Inclusion Criteria:

  • Age 18-49 years
  • Available for clinic visits at Tufts-New England Medical Center
  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) obtained
  • Ability of participant to understand and comply with the requirements of the protocol

Exclusion Criteria:

  • History of any medical conditions for which the CDC states should not be vaccinated with LAIV (asthma, reactive airways disease, other chronic disorders of the pulmonary or cardiovascular systems; metabolic diseases such as diabetes, renal dysfunction, and hemoglobinopathies; or persons with known or suspected immunodeficiency diseases)
  • Self-reported vaccination with the influenza vaccine for the current influenza season (2007-8); vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period; hypersensitivity to any influenza vaccine components including thimersol or egg or Guillain-Barre syndrome
  • Self-reported treatment with immunomodulator/immunosuppressor drugs (interleukins, corticosteriods (oral or inhaled)), G(M)-CSF in 4 weeks before enrollment or self-reported history of IL-2 administration within 5 years; use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination; medication use that might affect the immune response to a vaccine or effects of LGG (no antibiotics during the previous 4 weeks)
  • Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits
  • Health care or day care workers or close contacts with immunosuppressed persons because of the theoretical risk that LAIV could be transmitted to the immunosuppressed person and cause disease, per CDC recommendations
  • Use of LGG or other probiotics in 4 weeks before enrollment. Yogurt consumption is not an exclusion criteria, but subjects will be asked to avoid consumption of other lactobacilli and probiotic organisms during the study period
  • Abnormalities upon physical examination
  • Acute febrile illness on day of intended immunization - immunization deferred until illness resolved
  • Routine laboratory tests outside the limits outlined for this study:

    1. hemoglobin >=11.5g/dL for women; >=13.5 g/dL for men
    2. WBC 3,300-12,000 cells/mm^3
    3. Differential within normal range
    4. Platelets 125,000-550,000 /mm^3
    5. ALT <= upper limit of normal
    6. Serum creatinine <= upper limit of normal
    7. Normal urinalysis (negative glucose, negative or trace protein, and negative or trace hemoglobin)
    8. Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential because LAIV is contraindicated in pregnant women
    9. negative HIV test
    10. negative hepatitis B surface antigen
    11. negative anti-HCV
  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: NCT00620412

Sponsors and Collaborators
Tufts Medical Center
Amerifit Brands Inc
Investigators
Principal Investigator: Patricia L Hibberd, MD, PhD Tufts Medical Center
  More Information

No publications provided by Tufts Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia L. Hibberd, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00620412     History of Changes
Other Study ID Numbers: 7142
Study First Received: February 11, 2008
Last Updated: January 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
influenza
vaccines
probiotics
LGG

ClinicalTrials.gov processed this record on September 18, 2014