[HTML][HTML] A novel peptide-based pan-influenza A vaccine: a double blind, randomised clinical trial of immunogenicity and safety
JN Francis, CJ Bunce, C Horlock, JM Watson… - Vaccine, 2015 - Elsevier
JN Francis, CJ Bunce, C Horlock, JM Watson, SJ Warrington, B Georges, CB Brown
Vaccine, 2015•ElsevierAbstract 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 …
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 …
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.
Elsevier
