Forty-eight healthy males aged 18-40 were recruited for this single-centre, randomised, double blind study. Volunteers received one single low (250 渭g) or high (500 渭g) dose of FLU-v, either alone or adjuvanted. Safety, tolerability and basic immunogenicity (IgG and IFN-纬 responses) parameters were assessed pre-vaccination and for 21 days post-vaccination.
FLU-v was found to be safe and well tolerated with no vaccine associated severe adverse events. Dose-dependent IFN-纬 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.
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.