Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60: Evaluation of immunogenicity, cross-protection, safety and tolerability

I.R.C.C.S. "A.O.U. San Martino-IST"
Human Vaccines & Immunotherapeutics (Impact Factor: 2.37). 01/2013; 9(3). DOI: 10.4161/hv.23240
Source: PubMed


In the present study we first compare immunogenicity against vaccine and heterologous circulating A(H1N1)pdm09 strains, tolerability and safety of intradermal Intanza® 15 µg and of virosomal adjuvanted, intramuscularly delivered influenza vaccine, Inflexal® V, in healthy elderly volunteers. Five-hundred participants were enrolled in the study and randomly assigned to the two vaccine groups to receive either one dose of Intanza® 15 µg or Inflexal® V vaccine. All subjects reported solicited local and systemic reactions occurred within 7 d after vaccination and unsolicited adverse events up to 21 d post-immunization and any serious adverse event appeared during the study. A subset of 55 participants was randomly selected for immunogenicity and cross-protection evaluations. Serum samples were collected before and 1 and 3 mo after immunization. Antibody responses were measured using hemagglutination inhibition (HI) against all viruses used in the study and neutralization (NT) assays against A(H1N1)pdm09 strains. At least one of the CHMP criteria for influenza vaccine approval in the elderly was met by virosomal vaccine against all the tested viruses; intradermal vaccine met all criteria against all strains. Several parameters of immune response against strains with a different antigenic pattern from that of vaccine A/California/04/09(H1N1)pdm09 were significantly higher in the intradermal vaccine group compared with the virosomal group. Safety and systemic tolerability of both vaccines were excellent, but injection site reactions occurred significantly more frequently in the intradermal vaccination group. Immunogenicity of Intanza® 15 µg intradermal vaccine tended to be higher than that of Inflexal® V against heterologous strains in healthy elderly.

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    • "We also report that the intradermal vaccination showed significantly superior effectiveness compared with the virosomal vaccination. This observation is in agreement with the findings of a recent head-to-head randomized phase IV clinical trial of healthy elderly volunteers in which an intradermal-TIV 15 ␮g vaccine was associated with consistently higher seroprotection rates against homologous and heterologous strains when compared with a virosomal-TIV vaccine [23]. Other clinical studies have shown that in elderly volunteers the immunogenicity of intradermal-TIV 15 ␮g is comparable with that of an intramuscular subunit vaccine adjuvanted with MF59 [24]. "
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