tetano
Editor, Senior Moderator
Vaccine. 2014 Jun 10. pii: S0264-410X(14)00795-6. doi: 10.1016/j.vaccine.2014.06.006. [Epub ahead of print]
A novel peptide-based pan-influenza A vaccine: A double blind, randomised clinical trial of immunogenicity and safety.
Francis JN1, Bunce CJ2, Horlock C1, Watson JM1, Warrington SJ3, Georges B1, Brown CB1.
Author information
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 the150μg/peptide dose group where a robust response (243 spots/million PBMC above baseline) 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 was shown to 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. Published by Elsevier Ltd.
KEYWORDS:
Fluoropeptides; Immunogenicity; Influenza; Peptides; Safety; T cells; Vaccine
PMID:
24928790
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24928790
A novel peptide-based pan-influenza A vaccine: A double blind, randomised clinical trial of immunogenicity and safety.
Francis JN1, Bunce CJ2, Horlock C1, Watson JM1, Warrington SJ3, Georges B1, Brown CB1.
Author information
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 the150μg/peptide dose group where a robust response (243 spots/million PBMC above baseline) 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 was shown to 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. Published by Elsevier Ltd.
KEYWORDS:
Fluoropeptides; Immunogenicity; Influenza; Peptides; Safety; T cells; Vaccine
PMID:
24928790
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24928790