tetano
Editor, Senior Moderator
Vaccine. 2012 May 7. [Epub ahead of print]
Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial.
Pleguezuelos O, Robinson S, Stoloff GA, Caparr?s-Wanderley W.
Source
SEEK, Central Point, 45 Beech Street, London EC2Y 8AD, United Kingdom.
Abstract
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 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.
Copyright ? 2012. Published by Elsevier Ltd.
PMID:
22575166
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22575166
Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial.
Pleguezuelos O, Robinson S, Stoloff GA, Caparr?s-Wanderley W.
Source
SEEK, Central Point, 45 Beech Street, London EC2Y 8AD, United Kingdom.
Abstract
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 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.
Copyright ? 2012. Published by Elsevier Ltd.
PMID:
22575166
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22575166