Clinical trial NCT02962908 - References

Influenza — A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine

Citation(s)

•   Pleguezuelos O, Dille J, de Groen S, Oftung F, Niesters HGM, Islam MA, Næss LM, Hungnes O, Aldarij N, Idema DL, Perez AF, James E, Frijlink HW, Stoloff G, Groeneveld P, Hak E
  Immunogenicity, Safety, and Efficacy of a Standalone Universal Influenza Vaccin
•   Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Caparrós-Wanderley W
  Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans. Clin Vaccine Immunol. 2015 Aug;22(8):949-56. doi: 10.1128/CVI.00101-15. Epub 2015 Jun 17.
•   Pleguezuelos O, Robinson S, Fernández A, Stoloff GA, Mann A, Gilbert A, Balaratnam G, Wilkinson T, Lambkin-Williams R, Oxford J, Caparrós-Wanderley W
  A Synthetic Influenza Virus Vaccine Induces a Cellular Immune Response That Correlates with Reduction in Symptomatology and Virus Shedding in a Randomized Phase Ib Live-Virus Challenge in Humans. Clin Vaccine Immunol. 2015 Jul;22(7):828-35. doi: 10.1128/CVI.00098-15. Epub 2015 May 20.
•   Pleguezuelos O, Robinson S, Stoloff GA, Caparrós-Wanderley W
  Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial. Vaccine. 2012 Jun 29;30(31):4655-60. doi: 10.1016/j.vaccine.2012.04.089. Epub 2012 May 8.
•   Stoloff GA, Caparros-Wanderley W
  Synthetic multi-epitope peptides identified in silico induce protective immunity against multiple influenza serotypes. Eur J Immunol. 2007 Sep;37(9):2441-9.
•   van Doorn E, Pleguezuelos O, Liu H, Fernandez A, Bannister R, Stoloff G, Oftung F, Norley S, Huckriede A, Frijlink HW, Hak E
  Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial. BMC Infect Dis. 2017 Apr 4;17(1):241. doi: 10.1186/s12879-017-2341-9.

A Randomised, Double-blind, Placebo-controlled, Single-centre Phase IIb Trial as Part of the EU-funded UNISEC Project to Assess the Immunogenicity and Safety of Different Formulations and Dosing Regimens of FLU-v Vaccine in Healthy Adults

Details for clinical trial NCT02962908