Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v vaccine (Focetria™) in adult and elderly subjects

Gasparini, Roberto; Schioppa, F; Lattanzi, Maria; Barone, Michelangelo; Casula, D; Pellegrini, Michele; Veitch, Keith; Gaitatzis, N.

doi:10.1111/j.1742-1241.2009.02309.x

Cited by 35 publications

(24 citation statements)

References 9 publications

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“…Coinciding with the current influenza pandemic, caused by the new emergent A/H1N1 influenza viral strain, this characteristic has been demonstrated for the new MF59-adjuvanted A/H1N1 monovalent pandemic vaccine (Focetria ® , Novartis Vaccines, Italy), which has shown optimal immunogenicity in healthy adults, at a 7.5 μg antigen dosage. 40,41 The same is valid for another adjuvanted influenza vaccine, developed using an innovative adjuvant system, called AS03. This tocopherol oil-in-water emulsion-based adjuvant system has been tested, during the last few years, in a candidate H5N1 pre-pandemic influenza vaccine and has recently been adopted in the licensed formulation of a current A/H1N1 pandemic vaccine (Pandemrix ® , Glaxo Smith Kline, Germany): good Table 2.…”

Section: Critical Issues Desideratamentioning

confidence: 85%

“…Results showed that one dose of MF59-adjuvanted A/H1N1 monovalent vaccine, at a 7.5 μg antigen dosage, or even at the lower dose of 3.75 μg, with a half dose of MF59, provides protection for the majority of adults and elderly subjects, meeting the CHMP criteria for pandemic influenza vaccine licensure. 41 Although an exact evaluation of the effectiveness, offered by the influenza vaccines, is difficult to establish, some useful data concerning the clinical impact of the MF59-adjuvanted vaccine are available in the elderly. In particular, the effectiveness of the MF59-adjuvanted influenza vaccine has been demonstrated in older adults, thus avoiding emergency admissions for pneumonia including influenza B viruses of the B/Victoria and B/Yamagata lineages in future influenza vaccine preparations.…”

Section: -81mentioning

confidence: 99%

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Adjuvants and alternative routes of administration towards the development of the ideal influenza vaccine

Durando¹,

Iudici²,

Alicino³

et al. 2011

Human Vaccines

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Section: Critical Issues Desideratamentioning

confidence: 85%

Section: -81mentioning

confidence: 99%

Adjuvants and alternative routes of administration towards the development of the ideal influenza vaccine

Durando¹,

Iudici²,

Alicino³

et al. 2011

Human Vaccines

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“…Therefore seasonal TIV is generally not expected to confer a significant degree of cross-protection to pH1N1 [35]. Only older age by way of exposure to pre-1957 influenza strains has consistently been found to confer a relevant degree of cross-reactive antibodies to pH1N1 [17], [36]–[39]. In this respect it is interesting that we found that seasonal TIV was more likely to induce cross-reactive antibodies to pH1N1 in older than in younger subjects, which contradicts the conclusion of Hancock et al who found that seasonal TIV induces little to no cross-reactive antibody response to pH1N1 in any age group.…”

Section: Discussionmentioning

confidence: 99%

Response to 2009 Pandemic Influenza A (H1N1) Vaccine in HIV-Infected Patients and the Influence of Prior Seasonal Influenza Vaccination

et al. 2011

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BackgroundThe immunogenicity of 2009 pandemic influenza A(H1N1) (pH1N1) vaccines and the effect of previous influenza vaccination is a matter of current interest and debate. We measured the immune response to pH1N1 vaccine in HIV-infected patients and in healthy controls. In addition we tested whether recent vaccination with seasonal trivalent inactivated vaccine (TIV) induced cross-reactive antibodies to pH1N1. (clinicaltrials.gov Identifier:NCT01066169)Methods and FindingsIn this single-center prospective cohort study MF59-adjuvanted pH1N1 vaccine (Focetria®, Novartis) was administered twice to 58 adult HIV-infected patients and 44 healthy controls in November 2009 (day 0 and day 21). Antibody responses were measured at baseline, day 21 and day 56 with hemagglutination-inhibition (HI) assay. The seroprotection rate (defined as HI titers ≥1∶40) for HIV-infected patients was 88% after the first and 91% after the second vaccination. These rates were comparable to those in healthy controls. Post-vaccination GMT, a sensitive marker of the immune competence of a group, was lower in HIV-infected patients. We found a high seroprotection rate at baseline (31%). Seroprotective titers at baseline were much more common in those who had received 2009–2010 seasonal TIV three weeks prior to the first dose of pH1N1 vaccine. Using stored serum samples of 51 HIV-infected participants we measured the pH1N1 specific response to 2009–2010 seasonal TIV. The seroprotection rate to pH1N1 increased from 22% to 49% after vaccination with 2009–2010 seasonal TIV. Seasonal TIV induced higher levels of antibodies to pH1N1 in older than in younger subjects.ConclusionIn HIV-infected patients on combination antiretroviral therapy, with a median CD4+ T-lymphocyte count above 500 cells/mm3, one dose of MF59-adjuvanted pH1N1 vaccine induced a high seroprotection rate comparable to that in healthy controls. A second dose had a modest additional effect. Furthermore, seasonal TIV induced cross-reactive antibodies to pH1N1 and this effect was more pronounced in older subjects.

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“…Five vaccines were authorised by the European Medicines Agency (EMA) for use in the European Union [4]. Clinical trials reported high immunogenicity of the adjuvanted vaccines [5-10]; post-marketing studies [11-16] showed an effectiveness on preventing confirmed pH1N1 that was similar to that of seasonal influenza vaccines in well matched years [11,17]. So far, only limited and varying results have been reported on the effectiveness of the adjuvanted vaccines in preventing severe disease of pH1N1 that required hospitalisation [13,14,18].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of a MF-59™-adjuvanted pandemic influenza vaccine to prevent 2009 A/H1N1 influenza-related hospitalisation; a matched case-control study

Steens

Wijnans

Dieleman³

et al. 2011

BMC Infect Dis

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BackgroundDuring the 2009 influenza A/H1N1 pandemic, adjuvanted influenza vaccines were used for the first time on a large scale. Results on the effectiveness of the vaccines in preventing 2009 influenza A/H1N1-related hospitalisation are scanty and varying.MethodsWe conducted a matched case-control study in individuals with an indication for vaccination due to underlying medical conditions and/or age ≥ 60 years in the Netherlands. Cases were patients hospitalised with laboratory-confirmed 2009 A/H1N1 influenza infection between November 16, 2009 and January 15, 2010. Controls were matched to cases on age, sex and type of underlying medical condition(s) and drawn from an extensive general practitioner network. Conditional logistic regression was used to estimate the vaccine effectiveness (VE = 1 - OR). Different sensitivity analyses were used to assess confounding by severity of underlying medical condition(s) and the effect of different assumptions for missing dates of vaccination.Results149 cases and 28,238 matched controls were included. It was estimated that 22% of the cases and 28% of the controls received vaccination more than 7 days before the date of onset of symptoms in cases. A significant number of breakthrough infections were observed. The VE was estimated at 19% (95%CI -28-49). After restricting the analysis to cases with controls suffering from severe underlying medical conditions, the VE was 49% (95%CI 16-69).ConclusionsThe number of breakthrough infections, resulting in modest VE estimates, suggests that the MF-59™ adjuvanted vaccine may have had only a limited impact on preventing 2009 influenza A/H1N1-related hospitalisation in this setting. As the main aim of influenza vaccination programmes is to reduce severe influenza-related morbidity and mortality from influenza in persons at high risk of complications, a more effective vaccine, or additional preventive measures, are needed.

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Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v vaccine (Focetria™) in adult and elderly subjects

Cited by 35 publications

References 9 publications

Adjuvants and alternative routes of administration towards the development of the ideal influenza vaccine

Adjuvants and alternative routes of administration towards the development of the ideal influenza vaccine

Response to 2009 Pandemic Influenza A (H1N1) Vaccine in HIV-Infected Patients and the Influence of Prior Seasonal Influenza Vaccination

Effectiveness of a MF-59™-adjuvanted pandemic influenza vaccine to prevent 2009 A/H1N1 influenza-related hospitalisation; a matched case-control study

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