Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial
O Pleguezuelos, S Robinson, GA Stoloff… - Vaccine, 2012 - Elsevier
O Pleguezuelos, S Robinson, GA Stoloff, W Caparrós-Wanderley
Vaccine, 2012•ElsevierOBJECTIVES: Current Influenza vaccines elicit antibody mediated prophylactic immunity
targeted to viral capsid antigens. Despite their global use these vaccines must be
administered yearly to the population, cannot be manufactured until the circulating viral
strain (s) have been identified and have limited efficacy. A need remains for Influenza
vaccines addressing these issues and here we report the results of a Phase Ib trial of a
novel synthetic Influenza vaccine (FLU-v) targeting T cell responses to NP, M1 and M2 …
targeted to viral capsid antigens. Despite their global use these vaccines must be
administered yearly to the population, cannot be manufactured until the circulating viral
strain (s) have been identified and have limited efficacy. A need remains for Influenza
vaccines addressing these issues and here we report the results of a Phase Ib trial of a
novel synthetic Influenza vaccine (FLU-v) targeting T cell responses to NP, M1 and M2 …
OBJECTIVES
Current Influenza vaccines elicit antibody mediated prophylactic immunity targeted to viral capsid antigens. Despite their global use these vaccines must be administered yearly to the population, cannot be manufactured until the circulating viral strain(s) have been identified and have limited efficacy. A need remains for Influenza vaccines addressing these issues and here we report the results of a Phase Ib trial of a novel synthetic Influenza vaccine (FLU-v) targeting T cell responses to NP, M1 and M2.
METHODS
Forty-eight healthy males aged 18–40 were recruited for this single-centre, randomised, double blind study. Volunteers received one single low (250μg) or high (500μg) dose of FLU-v, either alone or adjuvanted. Safety, tolerability and basic immunogenicity (IgG and IFN-γ responses) parameters were assessed pre-vaccination and for 21 days post-vaccination.
RESULTS
FLU-v was found to be safe and well tolerated with no vaccine associated severe adverse events. Dose-dependent IFN-γ responses >2-fold the pre-vaccination level were detected in 80% and 100% of volunteers receiving, respectively, the low and high dose adjuvanted FLU-v formulations. No formulation tested induced any significant FLU-v antibody response.
CONCLUSION
FLU-v is safe and induces a vaccine-specific cellular immunity. Cellular immune responses are historically known to control and mitigate infection and illness during natural infection.
Elsevier
