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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    ABSTRACT: Background: The use of intradermal vaccination or virosomal vaccines could increase protection against influenza among the vulnerable population of older adults. Studies assessing the comparative effectiveness of these two influenza vaccine types in this age group are lacking. Methods: We conducted a retrospective cohort study to estimate the comparative effectiveness of intradermal seasonal trivalent-influenza vaccine (TIV) delivered by a microneedle injection system and a virosomal-TIV intramuscularly delivered for prevention of influenza hospitalization in non-institutionalized adults aged ≥65 years. We obtained administrative data on immunization status and influenza hospitalization for the 2011-2012 influenza season, and used Cox regression models to assess comparative effectiveness. We estimated crude and adjusted (age, sex, comorbidity, pharmaceutical claims, recent pneumococcal vaccination and number of hospitalizations for all causes other than influenza between the previous and current influenza seasons) hazard ratios (HR). Results: Overall, 164,021 vaccinated subjects were evaluated. There were 127 hospitalizations for influenza among 62,058 subjects, contributing 914,740 person-weeks at risk in the virosomal-TIV group, and 133 hospitalizations for influenza among 101,963 subjects, contributing 1,504,570 person-weeks at risk in the intradermal-TIV group. The crude HR of intradermal-TIV relative to virosomal-TIV was 0.64 (95% confidence interval (CI): 0.50-0.81), and the adjusted Cox estimated HR was 0.67 (95% CI: 0.52-0.85). Conclusions: During the 2011-2012 influenza season the risk of hospitalization for influenza was reduced by 33% in non-institutionalized elderly adults who were vaccinated with intradermal-TIV compared with virosomal-TIV.
    Full-text · Article · Aug 2014 · Vaccine
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    ABSTRACT: The elderly population is more susceptible to infections with higher risks of morbidity and mortality. This is caused by the accumulation of immune defects with aging. The best way to protect people against infections is vaccination. Unfortunately, the same immune defects that render the elderly susceptible to infectious diseases also prevent the development of protective immunity following immunization. A good example of this is the influenza vaccine that only protects between 40 and 60% of the vaccinees over 65 years. In the past decade, tremendous efforts have been put toward improving the influenza vaccine for the elderly. We therefore use this example to present various strategies employed to overcome these age-associated immune defects and hence make vaccines more efficacious for the aged.
    No preview · Article · Jun 2013 · Current opinion in immunology
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    ABSTRACT: New and reemerging infectious diseases call for innovative and efficient control strategies of which fast vaccine design and development represent an important element. In emergency situations, when time is limited, identification and use of correlates of protection (COPs) may play a key role as a strategic tool for accelerated vaccine design, testing, and licensure. We propose that general rules for COP-based vaccine design can be extracted from the existing knowledge of protective immune responses against a large spectrum of relevant viral and bacterial pathogens. Herein, we focus on the applicability of this approach by reviewing the established and up-coming COPs for influenza in the context of traditional and a wide array of new vaccine concepts. The lessons learnt from this field may be applied more generally to COP-based accelerated vaccine design for emerging infections.
    Full-text · Article · Apr 2014 · Human Vaccines & Immunotherapeutics
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