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.
RCT Entities:
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.
Authors: Lei Deng; Timothy Z Chang; Ye Wang; Song Li; Shelly Wang; Shingo Matsuyama; Guoying Yu; Richard W Compans; Jian-Dong Li; Mark R Prausnitz; Julie A Champion; Bao-Zhong Wang Journal: Proc Natl Acad Sci U S A Date: 2018-07-31 Impact factor: 11.205
Authors: Christof C Smith; Kelly S Olsen; Benjamin G Vincent; Alex Rubinsteyn; Kaylee M Gentry; Maria Sambade; Wolfgang Beck; Jason Garness; Sarah Entwistle; Caryn Willis; Steven Vensko; Allison Woods; Misha Fini; Brandon Carpenter; Eric Routh; Julia Kodysh; Timothy O'Donnell; Carsten Haber; Kirsten Heiss; Volker Stadler; Erik Garrison; Adam M Sandor; Jenny P Y Ting; Jared Weiss; Krzysztof Krajewski; Oliver C Grant; Robert J Woods; Mark Heise Journal: Genome Med Date: 2021-06-14 Impact factor: 15.266