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Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers

2014-08-27 03:18:02 | BioPortfolio

Summary

Vaccines induce protective immunity against numerous infectious diseases. However, current vaccines have limited efficacy against challenging infections like tuberculosis, malaria and HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when administered alone. Therefore, special attention is being given to adjuvants, which are enhancers of immunity, that mature antigen presenting immunostimulatory dendritic cells (DCs). Our goal is to study in humans the mechanism whereby synthetic adjuvants, acting on defined pattern recognition receptors (PRR), enhance T and B cell immunity. In preclinical studies, the investigators' laboratory has found in mice that poly IC and its analog poly ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR. In this study the investigators propose to study the safety and the innate immune responses to poly ICLC in multiple blood cell types, including three different subsets of DCs when administered subcutaneously or intranasally to healthy volunteers. Poly ICLC is a stabilized double stranded RNA which has been extensively studied in humans with a favorable safety profile.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Conditions

Healthy Volunteers

Intervention

Hiltonol (poly ICLC)

Location

The Rockefeller University
New York
New York
United States
10065

Status

Completed

Source

Rockefeller University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:02-0400

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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.

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