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2 results on '"Fluoropeptides"'

1. A novel peptide-based pan-influenza A vaccine: a double blind, randomised clinical trial of immunogenicity and safety.

Author

Francis JN, Bunce CJ, Horlock C, Watson JM, Warrington SJ, Georges B, and Brown CB

Subjects
Adult, Antibodies, Viral immunology, CD4-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes immunology, Cross Reactions, Double-Blind Method, Enzyme-Linked Immunospot Assay, Epitopes, T-Lymphocyte immunology, Flow Cytometry, Humans, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Interferon-gamma biosynthesis, Interferon-gamma immunology, Leukocytes, Mononuclear immunology, Male, Middle Aged, Vaccination, Vaccines, Subunit administration & dosage, Vaccines, Subunit adverse effects, Vaccines, Subunit immunology, Young Adult, Influenza Vaccines adverse effects, Influenza Vaccines immunology, T-Lymphocytes immunology
Abstract

Background: FP-01.1 is a novel synthetic influenza A vaccine consisting of six fluorocarbon-modified 35-mer peptides that encapsulate multiple CD4+ and CD8+ T-cell epitopes and is designed to induce an immune response across a broad population., Methods: FP-01.1 was evaluated for safety and immunogenicity in a randomised, double-blind, placebo-controlled, dose-escalation, phase I clinical study in healthy adult volunteers (n=49). IFNγ ELISpot assays and multicolour flow cytometry were used to characterise the immune response., Results: FP-01.1 was safe and well tolerated at all doses tested with a similar adverse event profile in actively vaccinated subjects compared with controls. Maximum immunogenicity was in the 150 μg/peptide dose group where a robust response (243 spots/million PBMC) was demonstrated in 75% subjects compared with 0% in placebo controls. All six peptides were immunogenic. FP-01.1 induced dual CD4+ and CD8+ T cell responses and vaccine-specific T cells cross-recognise divergent influenza strains., Conclusions: This first-in-human study showed that FP-01.1 has an acceptable safety and tolerability profile and generated robust anti-viral T cell responses in a high proportion of subjects tested. The results support the further clinical testing of FP-01.1 prior to clinical, proof-of-concept, live viral challenge studies., (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2015
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2. A novel peptide-based pan-influenza A vaccine: a double blind, randomised clinical trial of immunogenicity and safety

Author

James N. Francis, Campbell J. Bunce, Bertrand Georges, Jeannette M. Watson, Carlton B. Brown, Claire Horlock, and Steven J. Warrington

Subjects
Adult, CD4-Positive T-Lymphocytes, Male, Enzyme-Linked Immunospot Assay, T cell, T-Lymphocytes, Population, T cells, Epitopes, T-Lymphocyte, Cross immunity, CD8-Positive T-Lymphocytes, Cross Reactions, Fluoropeptides, Antibodies, Viral, Interferon-gamma, Young Adult, Immune system, Double-Blind Method, Immunology and Microbiology(all), Influenza, Human, Medicine, Humans, education, education.field_of_study, General Veterinary, General Immunology and Microbiology, business.industry, Immunogenicity, ELISPOT, Vaccination, Public Health, Environmental and Occupational Health, Middle Aged, Flow Cytometry, veterinary(all), Influenza, Infectious Diseases, medicine.anatomical_structure, Tolerability, Influenza Vaccines, Immunology, Vaccines, Subunit, Leukocytes, Mononuclear, Molecular Medicine, Safety, Peptides, business, Vaccine
Abstract

Background FP-01.1 is a novel synthetic influenza A vaccine consisting of six fluorocarbon-modified 35-mer peptides that encapsulate multiple CD4+ and CD8+ T-cell epitopes and is designed to induce an immune response across a broad population. Methods FP-01.1 was evaluated for safety and immunogenicity in a randomised, double-blind, placebo-controlled, dose-escalation, phase I clinical study in healthy adult volunteers ( n = 49). IFNγ ELISpot assays and multicolour flow cytometry were used to characterise the immune response. Results FP-01.1 was safe and well tolerated at all doses tested with a similar adverse event profile in actively vaccinated subjects compared with controls. Maximum immunogenicity was in the 150 μg/peptide dose group where a robust response (243 spots/million PBMC) was demonstrated in 75% subjects compared with 0% in placebo controls. All six peptides were immunogenic. FP-01.1 induced dual CD4+ and CD8+ T cell responses and vaccine-specific T cells cross-recognise divergent influenza strains. Conclusions This first-in-human study showed that FP-01.1 has an acceptable safety and tolerability profile and generated robust anti-viral T cell responses in a high proportion of subjects tested. The results support the further clinical testing of FP-01.1 prior to clinical, proof-of-concept, live viral challenge studies.

Published
2014

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