NCT01591473

Safety Study of FluMist With and Without Ampligen

A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist® Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen®.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: AIM ImmunoTech Inc. · Industry
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.

Detailed description

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	Poly I:Poly C12U 50 ug	Poly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days
DRUG	Poly I:Poly C12U 200 ug	Poly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days
DRUG	Poly I:Poly C12U 500 ug	Poly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days
DRUG	Poly I:Poly C12U 1250 ug	Poly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days
DRUG	Placebo	Placebo; 3 doses; nasal administration every 28 days
DRUG	FluMist	FluMist 0.2 ml; 3 doses; nasal administration every 28 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-09-01
• Completion: 2015-08-01
• First posted: 2012-05-04
• Last updated: 2018-07-26

Locations

1 site across 1 country: United States