Immunogenicity of trivalent subunit versus virosome-formulated influenza vaccines in geriatric patients

P, Conne; Gauthey, Laurent; Vernet, Philippe; Althaus, Beat; Que, John U.; Finkel, Beatriz; Glück, Reinhard; Cryz, Stanley J.

doi:10.1016/s0264-410x(97)00087-x

Cited by 99 publications

(31 citation statements)

References 26 publications

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“…This finding was also observed for a subset of patients who had nonprotective antibody titers at baseline. These good results were confirmed in a second clinical trial (5).…”

Section: Discussionsupporting

confidence: 54%

“…The stimulation of B lymphocytes also occurs through direct contact with the antigen-virosome complex (14,18). When tested for safety and immunogenicity in elderly nursing home residents in comparison to whole-virion and subunit vaccines, the virosome-formulated influenza vaccine was found to be superior with regard to reactogenicity and immunogenicity (5,15). This trivalent virosome influenza vaccine (Inflexal Berna V) is currently licensed in several European countries (e.g., Switzerland since 1997 and Italy since 1998).…”

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confidence: 99%

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Comparison of Immunogenicity and Safety of a Virosome Influenza Vaccine with Those of a Subunit Influenza Vaccine in Pediatric Patients with Cystic Fibrosis

Schaad

Buhlmann

Burger

et al. 2000

Antimicrob Agents Chemother

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The objective of this study was to compare the immunogenicity and safety of a single-dose regimen and a two-dose regimen of a trivalent virosome influenza vaccine (Inflexal Berna V) with those of a trivalent subunit influenza vaccine (Influvac) in children and adolescents with cystic fibrosis (CF). In an open, randomized, multicenter study with parallel groups, 11 young children with CF (1 to 6 years old) and 53 older children and adolescents with CF (>6 years old) were randomly assigned to one of the following immunization regimens: virosome vaccine at 0.5 ml on study day 0 or 0.25 ml on days 0 and 28 or a standard regimen of subunit vaccine, i.e., 0.5 ml on day 0 for older children and 0.25 ml on days 0 and 28 for younger children. Safety assessments, i.e., recording of systemic and local adverse events (AEs) and vital signs, were made for a 5-day observation period after each immunization. Hemagglutination inhibition (HI) titers were determined at baseline and 4 weeks after the single-dose and the two-dose immunizations, respectively. Immunogenicity was assessed according to the criteria of the European Agency for the Evaluation of Medicinal Products (EMEA). Both vaccines induced comparable HI antibody titers. Seroconversion (>4-fold rise in HI antibody titers, reaching a titer of >1:40) was achieved in 41 to 100% of the participants. Seroprotection (HI titer, >1:40) and a >2.5-fold increase in geometric mean titers were achieved in 100% of the participants. Thus, all three EMEA requirements for influenza vaccine efficacy were met by all treatment groups and for both vaccines. The virosome vaccine, when administered as a single dose, seemed to induce superior immunogenicity compared with the standard pediatric two-dose regimen. Totals of 42 and 57% of vaccinees receiving virosome and subunit vaccines, respectively, reported at least one local AE (predominantly pain). Totals of 84 and 71% of subjects receiving virosome and subunit vaccines, respectively, complained in response to questions of at least one systemic AE (mainly cough, fatigue, coryza, or headache). The majority of events were mild or moderate and lasted 1 or 2 days only. No obvious relationship was found between AE reporting rate and vaccine formulation, age group, or dose regimen. The relatively high AE reporting rate seemed to be partly related to the symptomatology of the underlying CF disease. In summary, the virosome and subunit vaccines induced in both age groups and against all three influenza strains an efficient immune response and were well tolerated by the children and adolescents with CF.

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“…This finding was also observed for a subset of patients who had nonprotective antibody titers at baseline. These good results were confirmed in a second clinical trial (5).…”

Section: Discussionsupporting

confidence: 54%

mentioning

confidence: 99%

Comparison of Immunogenicity and Safety of a Virosome Influenza Vaccine with Those of a Subunit Influenza Vaccine in Pediatric Patients with Cystic Fibrosis

Schaad

Buhlmann

Burger

et al. 2000

Antimicrob Agents Chemother

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“…We identified 60 eligible articles published between 1987 and 2006 describing inactivated seasonal influenza vaccine immunogenicity studies conducted in the United States, Canada, Europe, Israel, and Russia 10 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 . We included 129 independent study arms of which 119 reported data on response to A/H1N1, 109 on influenza B, and 108 on A/H3N2 vaccine strains (Table 1).…”

Section: Resultsmentioning

confidence: 99%

Quantitative review of antibody response to inactivated seasonal influenza vaccines

Seidman

Richard

Viboud

et al. 2011

Influenza Resp Viruses

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Please cite this paper as: Seidman et al. (2012) Quantitative review of antibody response to inactivated seasonal influenza vaccines. Influenza and Other Respiratory Viruses 6(1), 52–62. Background Seasonal influenza epidemics are associated with significant morbidity and mortality each year, particularly amongst young children and the elderly. Seasonal influenza vaccines have been available for decades, yet influenza remains a major public health threat in the US, sparking interest in studies evaluating the effectiveness of vaccination. Objectives We sought to identify determinants of serological responses to inactivated seasonal influenza vaccines including number of doses, adjuvant, and subject characteristics. Methods We reviewed 60 articles published between 1987 and 2006. We used weighted multiple logistic regression and random‐effects models to evaluate how seroconversion and seroprotection rates varied with host and vaccine factors. Results Both children and seniors tended to have poorer immune responses compared to adults whereas use of adjuvant and a second vaccine dose tended to improve immune response. Pre‐vaccination serological status had a large impact on the immune response to vaccination. We found substantial heterogeneity among studies, even with similar population settings and vaccination regimen. Conclusions Future studies should stratify their results by pre‐vaccination serological status in an effort to produce more precise summary estimates of vaccine response.

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“…with or without addition of extra lipids [13,17,28,29]. The safety and efficacy of virosomal influenza vaccines has been demonstrated to be as good as or even better than that of split or subunit vaccines in children, adults and healthy elderly or those with a medical condition [19,[30][31][32][33][34]. Importantly, due to their membranous nature, virosomal vaccines provide a platform for the incorporation of lipophilic or amphiphilic adjuvants [35][36][37][38][39][40].…”

Section: Discussionmentioning

confidence: 99%

Influenza virosomes supplemented with GPI-0100 adjuvant: a potent vaccine formulation for antigen dose sparing

Liu

Vries-Idema

Veer

et al. 2013

Med Microbiol Immunol

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Immunogenicity of trivalent subunit versus virosome-formulated influenza vaccines in geriatric patients

Cited by 99 publications

References 26 publications

Comparison of Immunogenicity and Safety of a Virosome Influenza Vaccine with Those of a Subunit Influenza Vaccine in Pediatric Patients with Cystic Fibrosis

Comparison of Immunogenicity and Safety of a Virosome Influenza Vaccine with Those of a Subunit Influenza Vaccine in Pediatric Patients with Cystic Fibrosis

Quantitative review of antibody response to inactivated seasonal influenza vaccines

Influenza virosomes supplemented with GPI-0100 adjuvant: a potent vaccine formulation for antigen dose sparing

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