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Leroux-Roels I.,Ghent University | Devaster J.-M.,Glaxosmithkline | Leroux-Roels G.,Ghent University | Verlant V.,Glaxosmithkline | And 9 more authors.
Vaccine | Year: 2015

Background: The protection elicited by polysaccharide pneumococcal vaccines against community-acquired pneumonia in older adults remains debatable. Alternative vaccine targets include well-conserved pneumococcal protein antigens, such as pneumococcal histidine triad protein D (PhtD). Objective: To evaluate humoral and cellular immune responses and safety/reactogenicity following immunisation with PhtD vaccine with or without adjuvant (alum or AS02V) in older (≥65 years) and young (18-45 years) healthy adults. Methods: Two phase I/II, single-blind, parallel-group studies were conducted in 150 older and 147 young adults. Participants were randomised to receive 2 doses (months 0 and 2) of PhtD 30μg, PhtD 10μg plus alum, PhtD 30μg plus alum, PhtD 10μg plus AS02V or PhtD 30μg plus AS02V, or the 23-valent polysaccharide pneumococcal vaccine (23PPV) at month 0 with placebo (saline solution) at month 2. Safety/reactogenicity was assessed. PhtD-specific antibody, T cell and memory B cell responses were evaluated. Results: Solicited adverse events were more common in young participants and with adjuvanted vaccines. No vaccine-related serious adverse events were reported. Although anti-PhtD geometric mean antibody concentrations (GMCs) were consistently lower in the older adult cohort than in young adults, GMCs in the older cohort following PhtD 30μg plus AS02V were comparable to those induced by plain PhtD or PhtD 30μg plus alum in the young cohort. Compared with alum adjuvant, AS02V adjuvant system was associated with an increased frequency of PhtD-specific CD4 cells in both cohorts and a significantly higher specific memory B cell response in the older cohort, similar to responses obtained in the young cohort. Conclusion: The improved immune response to PhtD vaccine containing the AS02V adjuvant system in comparison to alum suggests that the reduced immune response to vaccines in older adults can be partially restored to the response level observed in young adults. ClinicalTrials.gov identifiers: NCT00307528/NCT01767402. © 2014 The Authors. Source


Di Santo M.,Catholic University of Louvain | Vaz G.,Catholic University of Louvain | Doquier M.-A.,University Hospital St Luc | Raftopoulos C.,Catholic University of Louvain
Clinical Neurology and Neurosurgery | Year: 2015

Objective To describe our clip-reinforced wrapping technique (CRW) with collagen-impregnated Dacron and report our experience in intracranial aneurysms (IA) untreatable by coil embolization (CE) or surgical clipping (SC). Methods Between July 2003 and November 2010, CRW was performed on 20 IAs in 18 patients using a collagen-impregnated Dacron fabric (Hemashield®, USA) fixed with a clip around the parent vessel and the IA. Results Two patients (11%) died of complications from their subarachnoid hemorrhage and preexisting conditions. In the remaining 16 patients, after an average follow-up of 45 months (min: 27, max: 77), 16 (89%) out of the 18 treated aneurysms were no longer visible and two were reduced and stable. Conclusion Our preliminary results suggest that CRW with Hemashield could be an accurate and safe alternative technique for some IA without any other treatment option. Implications Description of an alternative surgical technique for otherwise untreatable intracranial aneurysms. © 2015 Elsevier B.V. Source


Mitra S.,University of Manchester | Cress C.,Washington University in St. Louis | Goovaerts T.,University Hospital St Luc
Hemodialysis International | Year: 2015

Creating and maintaining a successful home hemodialysis (HD) program is highly dependent on the workforce model and quality of staff. We describe the minimum staff required to start a home HD program (e.g., a clinical champion and lead nurse) and detail what additional workforce (e.g., renal technician, dietitian, psychologist, and others) may be necessary as the program evolves and expands. The goal of the program and allied staff should be to provide a seamless patient journey, a process that requires consideration of a patient recruitment strategy, a patient training pathway, thoughtful initiation of home HD, and development of support systems for routine care and emergencies at home. This module describes how care models are implemented at centers of excellence in various locations around the world, highlights the importance of an integrated care pathway, and describes workforce challenges that programs may encounter. © 2015 International Society for Hemodialysis. Source


Leroux-Roels G.,Ghent University | Van Belle P.,Glaxosmithkline | Vandepapeliere P.,Glaxosmithkline | Vandepapeliere P.,University of Paris Descartes | And 6 more authors.
Vaccine | Year: 2015

Background: Recombinant hepatitis B surface antigen (HBsAg) was used as a model antigen to evaluate persistence of cellular and humoral immune responses when formulated with three different Adjuvant Systems containing 3-O-desacyl-4'-monophosphoryl lipid A (MPL) and QS-21, in an oil-in-water emulsion (AS02B and AS02V), or with liposomes (AS01B). Methods: This is an open, 4-year follow-up of a previous randomised, double-blind study. Healthy subjects aged 18-40 years received three vaccine doses on a month 0, 1, 10 schedule and were initially followed for 18 months. A total of 93 subjects (AS02B: n=30; AS02V: n=28; AS01B: n=35) were enrolled in this follow-up and had an additional blood sample taken at Year 4 (NCT02153320). The primary endpoint was the frequency of HBsAg-specific CD4+ and CD8+ T-cells expressing cytokines upon short-term in vitro stimulation of peripheral blood mononuclear cells with HBsAg-derived peptides. Secondary endpoints were anti-HBs antibody titres and frequency of HBsAg-specific memory B-cells. Results: A strong and persistent specific CD4+ T-cell response was observed at Year 4 in all groups. HBsAg-specific CD4+ T-cells expressed mainly CD40L and IL-2, and to a lesser extent TNF-α and IFN-γ. HBsAg-specific CD8+ T-cells were not detected in any group. A high, persistent HBsAg-specific humoral immune response was observed in all groups, with all subjects seroprotected (antibody titre ≥10mIU/mL) at Year 4. The geometric mean antibody titre at Year 4 was above 100,000mIU/mL in all groups. A strong memory B-cell response was observed post-dose 2, which tended to increase post-dose 3 and persisted at Year 4 in all groups. Conclusion: The MPL/QS-21/HBsAg vaccine formulations induced persistent immune responses up to 4 years after first vaccination. These Adjuvant Systems offer potential for combination with recombinant, synthetic or highly purified subunit vaccines, particularly for vaccination against challenging diseases, or in specific populations, although additional studies are needed. © 2014 The Authors. Source


Mazzeo F.,University Hospital St Luc | Duck L.,Saint Pierre Hospital | Joosens E.,ZNA Campus Middelheim | Dirix L.,Sint Augustinus Hospital | And 8 more authors.
Anticancer Research | Year: 2011

Aim: To determine imatinib nonadherence rates in patients with gastrointestinal tumors (GIST) over 90 days. Patients and Methods: A prospective 90-day observational, open-label, multicenter study was carried out of 28 evaluable GIST patients on imatinib. Nonadherence behavior was measured using a 4-item patient interview. Clinicians, patients, and collaterals rated perceived patient adherence on a 0-100 VAS scale. Results: Nonadherence rates in the 4 weeks prior to baseline and follow-up were 29% (95% CI=26-32) and 24% (95% CI=21-27, p>0.05). Mean VAS ratings of perceived adherence ranged from 952±102 to 973±4.8 (p>0.05 for time and source of rating). Correlations between perceptions of and actual adherence behavior were negative. Conclusion: In this first study on imatinib nonadherence in GIST patients, rates were similar to those observed in patients with chronic myeloid leukemia, higher than clinically expected and exceeding meta-analytic estimates for cancer. Nonadherence rates were consistent across the 90-day period. Nonadherence behavior should be assessed by clinicians. Source

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