Immunopotentiation of trivalent influenza vaccine when given with VAX102, a recombinant influenza M2e vaccine fused to the TLR5 ligand flagellin
H Keipp Talbot, Michael T Rock, Casey Johnson, Lynda Tussey, Uma Kavita, Anita Shanker, Alan R Shaw, David N Taylor, H Keipp Talbot, Michael T Rock, Casey Johnson, Lynda Tussey, Uma Kavita, Anita Shanker, Alan R Shaw, David N Taylor
Abstract
Background: Currently controversy exists about the immunogenicity of seasonal trivalent influenza vaccine in certain populations, especially the elderly. STF2.4×M2e (VAX102) is a recombinant fusion protein that links four copies of the ectodomain of influenza virus matrix protein 2 (M2e) antigen to Salmonella typhimurium flagellin, a TLR5 ligand. The objectives of this study were to assess the feasibility of giving VAX102 and TIV in combination in an effort to achieve greater immunogenicity and to provide cross-protection.
Methodology/principal findings: Eighty healthy subjects, 18-49 years old, were enrolled in May and June 2009 in a double-blind, randomized, controlled trial at two clinical sites. Subjects were randomized to receive either TIV + VAX102 or TIV + placebo. Both arms tolerated the vaccines. Pain at the injection site was more severe with TIV + VAX102. Two weeks after immunization the HAI responses to the H1 and H3 antigens of TIV were higher in those that received TIV + VAX102 than in TIV + placebo (309 vs 200 and 269 vs 185, respectively), although statistically non-significant. There was no difference in the HAI of the B antigen. In the TIV + VAX102 arm, the geometric mean M2e antibody concentration was 0.5 µg/ml and 73% seroconverted.
Conclusions/significance: The combination of TIV + VAX102 has the potential to increase the immune response to the influenza A components of TIV and to provide M2e immunity which may protect against influenza A strains not contained in seasonal TIV.
Trial registration: ClinicalTrials.gov NCT00921973.
Conflict of interest statement
Competing Interests: HKBT has received research funding from Protein Sciences, VaxInnate, Sanofi Pasteur and Wyeth. MR has no conflicts of interest. Casey Johnson works for Johnson County Clin-Trials, which was hired by VaxInnate. Anita Shanker works for Health Decisions, which was hired by VaxInnate for data management. Lynda Tussey, Uma Kavita, Alan Shaw and David Taylor work for VaxInnate. This will not interfere with sharing data.
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Source: PubMed