Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

NCT ID: NCT00620412

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

treatment

Group Type: ACTIVE_COMPARATOR

Lactobacillus rhamnosus

Intervention Type: DIETARY_SUPPLEMENT

2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10\^10 LGG organisms.

Influenza Virus Vaccine Live, Intranasal

Intervention Type: BIOLOGICAL

intranasal spray, 0.1ml per nostril, one time dose

placebo

Group Type: PLACEBO_COMPARATOR

placebo control

Intervention Type: DIETARY_SUPPLEMENT

2 capsules by mouth twice a day for 28 days

Influenza Virus Vaccine Live, Intranasal

Intervention Type: BIOLOGICAL

intranasal spray, 0.1ml per nostril, one time dose

Interventions

Lactobacillus rhamnosus

2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10\^10 LGG organisms.

Intervention Type: DIETARY_SUPPLEMENT

placebo control

2 capsules by mouth twice a day for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Influenza Virus Vaccine Live, Intranasal

intranasal spray, 0.1ml per nostril, one time dose

Intervention Type: BIOLOGICAL

Other Intervention Names

Culturelle; FluMist

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amerifit Brands Inc

INDUSTRY

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tufts Medical Center

Principal Investigators

Patricia L Hibberd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

References

Davidson LE, Fiorino AM, Snydman DR, Hibberd PL. Lactobacillus GG as an immune adjuvant for live-attenuated influenza vaccine in healthy adults: a randomized double-blind placebo-controlled trial. Eur J Clin Nutr. 2011 Apr;65(4):501-7. doi: 10.1038/ejcn.2010.289. Epub 2011 Feb 2.

Reference Type: DERIVED

PMID: 21285968 (View on PubMed)

Other Identifiers

7142

Identifier Type: -

Identifier Source: org_study_id