Publications by authors named "Carlos Vallejo-Llamas"

3 Publications

  • Page 1 of 1

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.

JAMA 2019 07;322(2):123-133

Duke University Medical Center, Durham, North Carolina.

Importance: Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster.

Objective: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients.

Design, Setting, And Participants: Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT.

Interventions: Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter.

Main Outcomes And Measures: The primary end point was occurrence of confirmed herpes zoster cases.

Results: Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points.

Conclusions And Relevance: Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months.

Trial Registration: Identifier: NCT01610414.
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July 2019

[Bacteraemia and infection of the vascular catheter in the haematology patient: positioning and management based on the Delphi method].

Rev Esp Quimioter 2016 Feb 15;29(1):15-24. Epub 2016 Feb 15.

José Ramón Azanza Perea. Clínica Universidad de Navarra. Navarra; Dirección Avda Pío XII 36., Navarra, Spain.

Objective: Infectious complications are an important cause of morbidity and mortality in haematological patients with febrile neutropenia. The aim of this study was to develop a consensus document of recommendations to optimize the management of febrile neutropenic patients with haematological or vascular catheter infections in areas where there is no solid scientific evidence.

Methods: After reviewing the scientific evidence, a scientific committee composed of experts in haematology and infectious diseases developed a survey with 55 statements. A two- round modified Delphi method was used to achieve consensus.

Results: The online survey was answered by 52 experts in the field of haematology and infectious diseases. After two rounds of evaluation, a consensus was possible in 43 of the 55 statements (78.2%): 40 in agreement and 3 in disagreement. Recommendations are given related to empirical antibiotic treatment of patients with febrile neutropenia, mechanisms of action, toxicity and synergism of antibiotics in this context, modifications of antibiotic treatment in the course of febrile neutropenia, and the management of central vascular catheter infections in the haematological setting.

Conclusions: There is a high degree of agreement among experts on some controversial issues concerning the management of febrile neutropenia and catheter infection in hematologic patients. This agreement has resulted in recommendations that may be useful in clinical practice.
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February 2016

[Invasive fungal infection in haematology patients].

Enferm Infecc Microbiol Clin 2012 Nov 16;30(9):572-9. Epub 2012 Oct 16.

Unidad de Trasplante Hematopoyético, Hospital Universitario Central de Asturias, Oviedo, España.

Invasive fungal infection (IFI), caused by both yeasts and moulds, is a persistent problem, with high morbidity and mortality rates among patients on chemotherapy for haematology diseases, and hematopoietic stem cell transplant recipients. Management of IFI in these types of patients has become highly complex with the advent of new antifungals and diagnostic tests, resulting in different therapeutic strategies (prophylactic, empirical, pre-emptive, and targeted). A proper assessment of the risk for IFI of each individual patient appears to be critical in order to use the best prophylactic and therapeutic approach, and to increase the survival rates. Among the available antifungals, the most frequently used are fluconazole, mould-active azoles (itraconazole, posaconazole, voriconazole), candins (anidulafungin, caspofungin, micafungin), and amphotericin B (particularly its lipids formulations). Specific recommendations for use and the criteria for selection of antifungal agents are discussed in this paper.
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November 2012