The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.
Influenza epidemics continue to represent a significant medical problem in the developed as well as the developing world. Even with existing vaccines, annual influenza epidemics typically results in 20-50 million cases, resulting in 30,000-40,000 deaths in the U.S. alone. A possible pandemic could have even more devastating consequences. Current vaccines have a number of disadvantages including slow and expensive manufacturing, and a relative lack of efficacy in elderly, children and immune-compromised populations. These disadvantages would be multiplied during a pandemic. Use of Ampligen® as an adjuvant combined with FluMist® has a number of potential advantages as compared to traditional inactivated vaccines: it is simpler to administer (intranasally), generation of a broader immunity at the natural site of entry of the influenza virus as well as systemic immunity (and hence should be more efficacious than traditional vaccines) and may stimulate cross-protection against pre-pandemic H5N1 and/or H7N9 avian influenza strains. As FluMist®, due to its intranasal administration, imitates the natural entry of the influenza virus, it will generate local 'first-line' immunity as well as the traditional systemic immunity; therefore, at least theoretically provide greater protection than injectable vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
55
Poly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days
Poly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days
Poly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Evaluate safety and tolerability
Reactogenicity; other adverse events, serious adverse events, new onset of chronic illnesses, and adverse events of special interest
Time frame: Every 28 days
Evaluation of immune response
Evaluated by measurements of serum antibody HI titers against the seasonal viral strains contained in vaccine and various H5N1 and/or H7N9 clades. Immunogenicity will be evaluated by comparing the titer levels in each of the treatment groups.
Time frame: Every 28 days
Immunogenicity Assessments
Micro-neutralization assay and IgA (nasal wash and parotid saliva)
Time frame: Every 28 days
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Poly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days
Placebo; 3 doses; nasal administration every 28 days
FluMist 0.2 ml; 3 doses; nasal administration every 28 days