Search results for "clinical research"
showing 4 items of 474 documents
Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study
2016
Purpose The PRAME tumour antigen is expressed in several tumour types but in few normal adult tissues. A dose-escalation phase I/II study (NCT01149343) assessed the safety, immunogenicity and clinical activity of the PRAME immunotherapeutic (recombinant PRAME protein (recPRAME) with the AS15 immunostimulant) in patients with advanced melanoma. Here, we report the phase I dose-escalation study segment. Patients and methods Patients with stage IV PRAME-positive melanoma were enrolled to 3 consecutive cohorts to receive up to 24 intramuscular injections of the PRAME immunotherapeutic. The RecPRAME dose was 20, 100 or 500 µg in cohorts 1, 2 and 3, respectively, with a fixed dose of AS15. Advers…
Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial
2020
Funding: Transgène; International audience; Treatment of chronic hepatitis B (CHB) typically requires life-long administration of drugs. Cohort and pre-clinical studies have established the link between a functional T-cell-mounted immunity and resolution of infection. TG1050 is an adenovirus 5-based vaccine that expresses HBV polymerase and domains of core and surface antigen and has shown immunogenicity and antiviral effects in mice. We performed a phase 1 clinical trial to assess safety and explore immunogenicity and early efficacy of TG1050 in CHB patients. This randomized, double blind, placebo-controlled study included two sequential phases: one single dose cohort (SD, n = 12) and one …
Relationships Between Health Promoting Activities, Life Satisfaction, and Depressive Symptoms in Unemployed Individuals
2021
Background: Previous research has documented that unemployed individuals who engage in recreational activities, either alone or with others, experience higher levels of mental health and psychological well-being relative to those who do not engage in recreational activities. Aims: In this study, we examined whether engagement in health promoting activities, alone or with other family members, is associated with reduced levels of depression and enhanced levels of life satisfaction in unemployed individuals. Method: We employed a cross-sectional design in which we measured life satisfaction, depressive symptoms, consumption of healthy meals and engagement in physical activities in 203 unemplo…
Reciprocal relations between autonomous motivation from self-determination theory and social cognition constructs from the theory of planned behavior…
2020
Objectives The present study examined reciprocal relations between autonomous motivation from self-determination theory (SDT) and constructs from the theory of planned behavior (TPB) in a sport injury context. Methods The study adopted a three-wave longitudinal cross-lagged panel design. Physical education students in China (N = 4414; Mage = 14.42, SD = 1.75) completed self-report measures of autonomous motivation, attitude, subjective norm, and perceived behavioral control with respect to sport injury prevention at baseline (T1) and at two follow-up occasions one (T2) and three (T3) months later. Proposed reciprocal relations between autonomous motivation and the TPB constructs controlling…