scholarly journals Influenza and Meningococcal Vaccinations Are Effective in Healthy Subjects Treated with the Interleukin-1β-Blocking Antibody Canakinumab: Results of an Open-Label, Parallel Group, Randomized, Single-Center Study

2010 ◽  
Vol 17 (12) ◽  
pp. 1952-1957 ◽  
Author(s):  
A. Chioato ◽  
E. Noseda ◽  
S. D. Felix ◽  
M. Stevens ◽  
G. Del Giudice ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Fold Increase ◽  
Antibody Responses ◽  
Control Group ◽  
Primary Efficacy Variable ◽  
Primary Efficacy ◽  
Open Label ◽  
Parallel Group ◽  
Single Center Study ◽  
Virus Strains

ABSTRACT The objective of this study was to evaluate the efficacy of influenza and meningococcal vaccines in healthy subjects exposed to the anti-interleukin-1β (anti-IL-1β) monoclonal antibody canakinumab. This was an open-label, parallel group, randomized, single-center study of healthy subjects (aged 18 to 45 years). At baseline, antibody (Ab) titers were measured and subjects were randomized (1:1) to a single 300-mg canakinumab dose administered subcutaneously (s.c.) or received no treatment (control group). After 2 weeks, subjects were treated with inactivated, unadjuvanted influenza and conjugated group C meningococcal (MenC) vaccines, administered intramuscularly (i.m.). The primary efficacy variable was the response (≥2-fold increase in Ab titer in ≥2 of 3 influenza virus strains) after 4 weeks in subjects treated with canakinumab compared to the control group. Secondary efficacy variables were the antibody response to vaccines at different thresholds and time points. Fifty-one of 112 subjects screened were randomized to canakinumab (n = 25) or the control group (n = 26). Antibody responses to vaccinations measured against different influenza virus strains and one MenC strain at 4 weeks were comparable in the canakinumab and control groups. The primary efficacy variable, the response to influenza vaccination (≥2-fold increase in Ab titer in ≥2 of 3 serotypes) at 4 weeks, was shown in 24/25 subjects in the canakinumab group compared to 25/25 subjects in the control group. Antibody responses remained comparable in the two groups at the different time points assessed. Headache was the most frequently reported adverse event. No deaths or serious adverse events were reported during the study. We concluded that a single dose of 300 mg canakinumab s.c. does not affect the induction or persistence of antibody responses after vaccination with unadjuvanted influenza or alum-adjuvanted MenC vaccines in healthy subjects.

scholarly journals Treatment with the Interleukin-17A-Blocking Antibody Secukinumab Does Not Interfere with the Efficacy of Influenza and Meningococcal Vaccinations in Healthy Subjects: Results of an Open-Label, Parallel-Group, Randomized Single-Center Study

2012 ◽  
Vol 19 (10) ◽  
pp. 1597-1602 ◽  
Author(s):  
A. Chioato ◽  
E. Noseda ◽  
M. Stevens ◽  
N. Gaitatzis ◽  
A. Kleinschmidt ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Healthy Subjects ◽  
Antibody Responses ◽  
Control Group ◽  
Single Center ◽  
Open Label ◽  
Interleukin 17A ◽  
Parallel Group ◽  
Single Center Study ◽  
Center Study

ABSTRACTOur objective was to evaluate the efficacy of influenza and meningococcal vaccinations in healthy subjects exposed to the anti-interleukin-17A (IL-17A) monoclonal antibody (MAb) secukinumab. We used an open-label, parallel-group, randomized single-center study of 50 healthy subjects. Subjects received a single 150-mg dose of secukinumab or no treatment, followed by vaccination with inactivated trivalent subunit influenza virus and conjugate group C meningococcal vaccine (Agrippal and Menjugate, respectively) 2 weeks later. Primary efficacy variables were responses of ≥4-fold increases in antibody titer (hemagglutination inhibition [HI; for influenza virus] and serum bactericidal assay [SBA; forNeisseria meningitides]) for meningococcus and influenza (at least two out of three serotypes), both at 4 weeks postvaccination. All subjects randomized to secukinumab (n= 25) or the control (n= 25) completed the study. Antibody responses to vaccinations measured at 4 weeks were comparable in both groups, with ≥4-fold increased responses following influenza virus vaccination of 20/25 (80%) for both groups and following meningococcal vaccination of 19/25 (76%) for the secukinumab group and 18/25 (72%) for the control group. Differences between groups were 0% (90% confidence intervals [CI], 19 and 19%) and 4% (90% CI, 16 and 24%) for influenza virus and meningococcal vaccines, respectively. Antibody responses were comparable between the 2 groups at different time points. Headache was the most frequently reported adverse effect. No deaths or serious adverse events were reported. Blockade of IL-17A by secukinumab does not appear to interfere with efficacy of influenza and meningococcal vaccinations, as assessed by the achievement of protective antibody levels. A protective (≥4-fold) immune response to both vaccinations at 4 weeks was achieved in 80 and 76% of subjects exposed to secukinumab and the control, respectively.

scholarly journals Impact of valganciclovir therapy on severe IRIS-Kaposi Sarcoma mortality: an open-label, parallel, randomized controlled trial.

2021 ◽  
Author(s):  
Patricia Volkow ◽  
Leslie Chavez-Galan ◽  
Lucero Ramon-Luing ◽  
Judith Cruz-Velazquez ◽  
Patricia Cornejo-Juarez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Kaposi Sarcoma ◽  
Pulmonary Involvement ◽  
Skin Lesions ◽  
Attributable Mortality ◽  
Control Group ◽  
Open Label ◽  
Parallel Group ◽  
Pulmonary Lymph Node ◽  
The Difference

High HHV-8 viral load (VL) in Kaposi Sarcoma (KS) has been associated with severe Immune reconstitution inflammatory syndrome (S-IRIS-KS), which can occur after initiating cART, and is linked with high mortality particularly in patients with pulmonary involvement. We investigate if valganciclovir initiated before cART decreases HHV-8 VL and assess if it reduces the incidence of S-IRIS-KS and its attributable mortality. Methods: Open-label parallel-group randomized clinical trial in AIDS cART naive patients with disseminated KS (DKS) as defined by at least two of the following: pulmonary, lymph-node or gastrointestinal involvement, lymphedema, or equal or more 30 skin lesions. In the experimental group (EG), patients were randomized to valganciclovir 900 mg BID four weeks before cART and continued until week-48; in the control group (CG), cART was initiated on week-0. Non-severe-IRIS-KS was defined as: increase in the number of lesions plus equal or more than one log10 HIV-VL decrease or equal or more than 50 cells/mm3 increase or equal or more than 2-fold rise in baseline CD4+ cells. S-IRIS-KS was defined as abrupt clinical worsening of KS lesions and/or fever after ruling out another infection following cART initiation, and at least three of the following: thrombocytopenia, anemia, hyponatremia, or hypoalbuminemia. Results: 40 patients were randomized and 37 completed the study. In the ITT analysis, the overall mortality did not differ between groups. In the per-protocol analyses, the difference showed a trend for higher S-IRIS-KS mortality in the CG 3/19 (15.7%), compared to EG 0/18 (p=0.07). The incidence of S-IRIS KS was significantly lower in the EG; two patients, one each had S-IRIS-KS episode (0.038 per 100 patient-days) compared to CG group, four patients developed 12 S-IRIS-KS episodes (0.21 per 100 patient-days); incidence rate of 0.09 (95% CI 0.02-0.5 p=0.006). Mortality in patients with pulmonary KS was significantly lower in EG, 3/4 in CG vs 0/5 in EG. S-IRIS-KS was associated with higher HHV-8-VL; IL6 and CRP; valganciclovir was protective. Of survivors at week 48, 82% achieved more than 80% remission. No difference was found between groups in the number of non-S-IRIS-KS events. Conclusions: Valganciclovir significantly reduced the episodes of S-IRIS-KS although attributable KS mortality was lower in the EG the difference was not significant (p=0.07). Mortality was significantly lower in EG patients with pulmonary KS.

scholarly journals Micronutrients in support to the one carbon cycle for the modulation of blood fasting homocysteine in PCOS women

2019 ◽  
Vol 43 (6) ◽  
pp. 779-786 ◽  
Author(s):  
N. Schiuma ◽  
A. Costantino ◽  
T. Bartolotti ◽  
M. Dattilo ◽  
V. Bini ◽  
...  
Keyword(s):  
Carbon Cycle ◽  
Normal Limit ◽  
Control Group ◽  
Pharmacological Treatments ◽  
Open Label ◽  
Parallel Group ◽  
Alternative Approach ◽  
The Mean ◽  
The One

Abstract Purpose Fasting blood homocysteine is increased in PCOS women and is involved in several of its co-morbidities including cardiovascular disease and infertility. Corrective interventions based on the administration of supra-physiologic doses of folic acid work to a low extent. We aimed to test an alternative approach. Methods This was a prospective, randomized, parallel group, open label, controlled versus no treatment clinical study. PCOS women aged > 18, free from systemic diseases and from pharmacological treatments were randomized with a 2:1 ratio for treatment with activated micronutrients in support to the carbon cycle (Impryl, Parthenogen, Switzerland—n = 22) or no treatment (n = 10) and followed-up for 3 months. Fasting blood homocysteine, AMH, testosterone, SHBGs, and the resulting FTI were tested before and at the end of the follow-up. Results The mean baseline fasting blood homocysteine was above the normal limit of 12 μMol/L and inversely correlated with SHBG. AMH was also increased, whereas testosterone, SHBG, and FTI were within the normal limit. The treatment achieved a significant reduction of homocysteine, that did not change in the control group, independently of the starting value. The treatment also caused an increase of AMH and a decrease of SHBGs only in the subgroup with a normal homocysteine at baseline. Conclusions In PCOS ladies, blood homocysteine is increased and inversely correlated with the SHBGs. Physiologic amounts of activated micronutrients in support to the carbon cycle achieve a reduction virtually in all exposed patients. Whether this is of clinical benefit remains to be established.

Exercise training leads to a reduction of elevated myostatin levels in patients with chronic heart failure

2011 ◽  
Vol 19 (3) ◽  
pp. 404-411 ◽  
Author(s):  
Karsten Lenk ◽  
Sandra Erbs ◽  
Robert Höllriegel ◽  
Ephraim Beck ◽  
Axel Linke ◽  
...  
Keyword(s):  
Heart Failure ◽  
Skeletal Muscle ◽  
Chronic Heart Failure ◽  
Exercise Training ◽  
Serum Concentration ◽  
Late Stage ◽  
Healthy Subjects ◽  
Fold Increase ◽  
Control Group ◽  
Cardiac Cachexia

Background: In chronic heart failure (CHF), cardiac cachexia is often associated with the terminal stage of this disease. In animal studies it has been demonstrated that myostatin, a key regulator of skeletal muscle mass, is elevated in advanced stages of this syndrome. Design: The aim of the present study was to investigate the expression of myostatin in patients with late stage CHF (NYHA IIIb) in comparison to healthy subjects. Furthermore the effects of physical exercise on myostatin were analyzed. Methods: Twenty-four patients were either randomized to a sedentary control group (CHF-S) or exercise training (CHF-E). At baseline and after 12 weeks mRNA and myostatin protein in the peripheral skeletal muscle as well as myostatin serum concentration were measured. Furthermore 12 age-matched healthy men were compared to all patients at baseline (HC). Results: CHF patients showed a two-fold increase of myostatin mRNA ( p = 0.05) and a 1.7-fold ( p = 0.01) augmentation of protein content in skeletal muscle compared to healthy subjects. In late-stage CHF, exercise training led to a 36% reduction of the mRNA and a 23% decrease of the myostatin protein compared to baseline. The serum concentration of myostatin revealed no significant alteration between the groups. Conclusion: In the skeletal muscle, myostatin increases significantly in the course of CHF. The observed effects of a significant reduction of myostatin in skeletal muscle after 12 weeks of exercise training demonstrate the reversibility of molecular changes that might be able to halt the devastating process of muscle wasting in chronic heart failure.

TREATMENT EFFECTS OF VORTIOXETINE ON COGNITIVE FUNCTIONS IN MILD ALZHEIMER’S DISEASE PATIENTS WITH DEPRESSIVE SYMPTOMS: A 12 MONTH, OPEN-LABEL, OBSERVATIONAL STUDY

2019 ◽  
pp. 1-6 ◽  
Author(s):  
E. Cumbo ◽  
S. Cumbo ◽  
S. Torregrossa ◽  
D. Migliore
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Depressive Symptoms ◽  
Cognitive Functions ◽  
Digit Span ◽  
Control Group ◽  
Cognitive Tests ◽  
Open Label ◽  
Parallel Group ◽  
Study Setting

BACKGROUND/OBJECTIVES:depressive symptoms are common in Alzheimer’s disease(AD). Aim of the study was to investigate the efficacy of vortioxetine compared with other conventional antidepressants on cognitive functions in AD patients with depressive symptoms. DESIGN: Prospective, randomized, 12 month, parallel-group study. SETTING: All participants were evaluated on-site at Neurodegenerative Disorders Unit, ASP2 Caltanissetta(Italy). PARTICIPANTS: 108(71 female, 37 male) AD patients with depression(mean age 76.7± 4.3). INTERVENTION: Randomized subjects received vortioxetine, 15 mg/day(n=36) or other common antidepressants(n=72). MEASURES:primary outcome was change from baseline in the MMSE; secondary outcomes were change in Attentive Matrices, Raven Coloured Progressive Matrices, Digit Span, HAM-D and Cornell scale. RESULTS: Statistically significant improvement vs. controls was observed for vortioxetine on most of the cognitive tests and showed significantly baseline-to-endpoint reduction in both HAM-D and Cornell total scores.The most commonly reported adverse events were nausea and headache for votioxetine; nausea in the control group. CONCLUSIONS: Vortioxetine had a beneficial effect on cognition and mood in elderly AD patients and was safe and well tolerated.

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