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Safety Study of FluMist With and Without Ampligen

2014-12-16 14:23:23 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza, Human

Intervention

FluMist + Poly I:Poly C12U 50 ug, FluMist + Poly I:Poly C12U 200 ug, FluMist + Poly I:Poly C12U 500 ug, FluMist + Poly I:Poly C12U 1250 ug, FluMist + Placebo

Location

The University of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Recruiting

Source

Hemispherx Biopharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-12-16T14:23:23-0500

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Medical and Biotech [MESH] Definitions

A poly(A) binding protein that is involved in promoting the extension of the poly A tails of MRNA. The protein requires a minimum of ten ADENOSINE nucleotides in order for binding to mRNA. Once bound it works in conjunction with CLEAVAGE AND POLYADENYLATION SPECIFICITY FACTOR to stimulate the rate of poly A synthesis by POLY A POLYMERASE. Once poly-A tails reach around 250 nucleotides in length poly(A) binding protein II no longer stimulates POLYADENYLATION. Mutations within a GCG repeat region in the gene for poly(A) binding protein II have been shown to cause the disease MUSCULAR DYSTROPHY, OCULOPHARYNGEAL.

A poly(ADP-ribose) polymerase that contains two ZINC FINGERS in its N-terminal DNA-binding region. It modifies NUCLEAR PROTEINS involved in chromatin architecture and BASE EXCISION REPAIR with POLY ADENOSINE DIPHOSPHATE RIBOSE.

A poly(A) binding protein that has a variety of functions such as mRNA stabilization and protection of RNA from nuclease activity. Although poly(A) binding protein I is considered a major cytoplasmic RNA-binding protein it is also found in the CELL NUCLEUS and may be involved in transport of mRNP particles.

Post-translational modification of proteins with POLY ADENOSINE DIPHOSPHATE RIBOSE.

The addition of a tail of polyadenylic acid (POLY A) to the 3' end of mRNA (RNA, MESSENGER). Polyadenylation involves recognizing the processing site signal, (AAUAAA), and cleaving of the mRNA to create a 3' OH terminal end to which poly A polymerase (POLYNUCLEOTIDE ADENYLYLTRANSFERASE) adds 60-200 adenylate residues. The 3' end processing of some messenger RNAs, such as histone mRNA, is carried out by a different process that does not include the addition of poly A as described here.

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