Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

NCT00620412 | Completed Phase 1 DMC

• 1 other identifier: 7142
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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

Keywords

influenza; vaccines; probiotics; LGG

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (1)

• To assess time course of antibody response after administration of influenza vaccine (LAIV) and to compare responses in subjects receiving LGG versus placebo

  2 weeks

Study Arms (2)

treatment

ACTIVE COMPARATOR

Dietary Supplement: Lactobacillus rhamnosus; Biological: Influenza Virus Vaccine Live, Intranasal

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo control; Biological: Influenza Virus Vaccine Live, Intranasal

Interventions

Lactobacillus rhamnosus DIETARY_SUPPLEMENT

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

Also known as: Culturelle

treatment

placebo control DIETARY_SUPPLEMENT

2 capsules by mouth twice a day for 28 days

placebo

Influenza Virus Vaccine Live, Intranasal BIOLOGICAL

intranasal spray, 0.1ml per nostril, one time dose

Also known as: FluMist

placebo; treatment

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• hemoglobin \>=11.5g/dL for women; \>=13.5 g/dL for men
• WBC 3,300-12,000 cells/mm\^3
• Differential within normal range
• Platelets 125,000-550,000 /mm\^3
• ALT \<= upper limit of normal
• Serum creatinine \<= upper limit of normal
• Normal urinalysis (negative glucose, negative or trace protein, and negative or trace hemoglobin)

Sponsors & Collaborators

• Tufts Medical Center: lead
• Amerifit Brands Inc: collaborator

Related Publications (1)

• 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.

  PMID: 21285968 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Patricia L Hibberd, MD, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2009
• Last Updated: January 19, 2011

Record last verified: 2011-01