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.

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 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 (250 μg) or high (500 μg) 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.

Trial registration: ClinicalTrials.gov NCT01181336.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood
  • Dose-Response Relationship, Immunologic
  • Double-Blind Method
  • Humans
  • Immunity, Cellular*
  • Immunoglobulin G / blood
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / immunology*
  • Influenza, Human / prevention & control*
  • Interferon-gamma / immunology
  • Male
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / immunology
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Influenza Vaccines
  • Vaccines, Synthetic
  • Interferon-gamma

Associated data

  • ClinicalTrials.gov/NCT01181336