A5026902040- Escherichia coli research studies
- Viral gastroenteritis research and epidemiology
- Clostridium difficile and Clostridium perfringens research
- Neutropenia and Cancer Infections
- Blood disorders and treatments
- Biosimilars and Bioanalytical Methods
- Salmonella and Campylobacter epidemiology
- Pharmaceutical Economics and Policy
- Mental Health Treatment and Access
- Pharmaceutical studies and practices
- Atrial Fibrillation Management and Outcomes
- Estrogen and related hormone effects
- Diphtheria, Corynebacterium, and Tetanus
- Cancer Risks and Factors
- Retinal Imaging and Analysis
- Brucella: diagnosis, epidemiology, treatment
- Attention Deficit Hyperactivity Disorder
- Pharmacovigilance and Adverse Drug Reactions
- Migration, Health and Trauma
- Treatment of Major Depression
- Schizophrenia research and treatment
- Blood donation and transfusion practices
- Venous Thromboembolism Diagnosis and Management
- Hepatitis Viruses Studies and Epidemiology
- Cardiac electrophysiology and arrhythmias
Toscana Life Sciences
2019-2024
GlaxoSmithKline (Italy)
2021-2024
Global Vaccines (United States)
2021-2023
Regione Lombardia
2012-2014
University of Milano-Bicocca
2007
The investigational Shigella sonnei vaccine (1790GAHB) based on GMMA (generalized modules for membrane antigens) is immunogenic, with an acceptable safety profile in adults. However, pre-vaccination anti-S. lipopolysaccharide (LPS) antibody levels seemed to impact vaccine-related immune responses. This phase 1, open-label, non-randomized extension study (ClinicalTrials.gov: NCT03089879) evaluated immunogenicity of a 1790GAHB booster dose seven adults undetectable antibodies prior priming...
Shigellosis accounts for substantial morbidity and mortality worldwide is the second most common cause of moderate severe diarrhoea in children.This phase 2b study (NCT03527173), conducted between August 2018 November 2019, evaluated vaccine efficacy (VE), safety, immunogenicity a Shigella sonnei GMMA candidate (1790GAHB) adults, using S. 53 G controlled human infection model. Participants (randomized 1:1) received two doses 1790GAHB or placebo (GAHB-Placebo), at day (D) 1 D29, an oral...
We report data from Stage 1 of an ongoing two-staged, phase I/II randomized clinical trial (NCT05073003) with a 4-component Generalized Modules for Membrane Antigens-based vaccine against Shigella sonnei and S. flexneri 1b, 2a 3a (altSonflex1-2-3, GSK).
Shigella is the second most deadly diarrheal disease among children under five years of age, after rotavirus, with high morbidity and mortality in developing countries. Currently, no vaccine widely available, increasing levels multidrug resistance make a priority for development. The single-component candidate against sonnei (1790GAHB), developed using GMMA technology, contains O antigen (OAg) portion lipopolysaccharide (LPS) as active moiety. was well tolerated immunogenic early-phase...
ABSTRACT Shigella is a leading cause of diarrheal morbidity and mortality in young children from low- middle-income countries. Here, we aimed to verify the ability generalized modules for membrane antigens (GMMA)-based sonnei candidate vaccine 1790GAHB elicit an anti-protein antibody response. Serum samples previous clinical trials adults (a dose-escalation study its extension France, efficacy after human challenge United States, Kenya) were investigated using pan-proteome microarrays...
Direct oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered aspects remain be addressed available evidence on the risk associated with these drugs are conflicting. In order contribute debate their profile, we conducted comparative analysis of reports suspected adverse drug reactions (ADRs) DOACs VigiBase.
Shigella is associated with a significant burden of disease worldwide among individuals all ages and the major cause moderate severe diarrhea in children under five years age low- middle-income countries. Several candidate vaccines against species are currently clinical development. The investigational 1790GAHB vaccine sonnei based on GMMA (Generalized Modules for Membrane Antigens) technology. was well tolerated induced high antibody levels early-phase trials both -endemic non-endemic...
Abstract Shigella spp. are a leading bacterial cause of diarrhea. No widely licensed vaccines available and there is no generally accepted correlate protection. We tested S. sonnei Generalized Modules for Membrane Antigen (GMMA)-based vaccine (1790GAHB) in phase 2b, placebo-controlled, randomized, controlled human infection model study (NCT03527173) enrolling healthy United States adults aged 18–50 years. report analyses evaluating immune responses to vaccination, with the aim identify...
Background Shigellosis mainly affects children under 5 years of age living in low- and middle-income countries, who are the target population for vaccination. There are, however, limited data available to define appropriate timing vaccine administration this group. Information on antibody responses following natural infection, proxy exposure, could help guide vaccination strategies. Methods We undertook a retrospective analysis antibodies five most prevalent Shigella serotypes among aged...
One of the major challenges with antidepressant (AD) use is poor adherence and early treatment discontinuation. In addition to socio-demographic clinical variables, discontinuation may also be related capacity health system assure maintain continuity intensity care. Among factors that interfere pharmacological treatment, generic drugs play a key role. It has been argued that, although lower cost generics favour persistence on widespread priori scepticism about their effectiveness safety by...
A computer assisted model was created with the data from 514 consecutive coronary bypass patients in order to predict potential need of a blood transfusion. During this time period strict management protocols were used. In series 261 (55.9 %) never and 46 (9.9 only intraoperatively transfused. Intra- postoperative transfusions necessary for 160 (34.2 patients. Preoperative hematocrit, age, sex, weight statistically significant parameters development model.
Shigellosis is a major health concern among children < 5 years of age from developing countries, and there are no widely available vaccines to prevent it. The GMMA-based 1790GAHB investigational vaccine against Shigella sonnei was well tolerated immunogenic in phase 1 2 studies conducted healthy adults endemic non-endemic populations. Based on pooled data five individual trials, we assessed the association between administration risk neutropenia as overall safety profile 1790GAHB. ratio (RR)...
Typhoid and Paratyphoid fever cause a global health burden, especially for the children of Southern Asia. The impact disease is further exacerbated by dramatic increase antimicrobial resistance. While vaccines against
Dear Sir,W e have read with attention and interest the systematic review on effectiveness safety of bevacizumab ranibizumab in treatment age-related macular degeneration(AMD)written by Zhang et al[1]and published number April 2014 International Journal Ophthalmology.The authors,who collected data from 4randomized clinical trials(RCTs)and 11 observational
Abstract Shigella spp. are a leading bacterial cause of diarrhea. No widely licensed vaccines available and there is no generally accepted correlate protection. We tested S. sonnei GMMA-based vaccine (1790GAHB) in phase 2b, placebo-controlled, randomized, controlled human infection model study (NCT03527173) enrolling healthy US adults aged 18–50 years. report analyses evaluating immune responses to vaccination, with the aim identify correlates risk for shigellosis among assessed...
Abstract Shigella spp. are a leading bacterial cause of diarrhea. No widely licensed vaccines available and there is no generally accepted correlate protection. We tested S. sonnei Generalized Modules for Membrane Antigen (GMMA)-based vaccine (1790GAHB) in phase 2b, placebo-controlled, randomized, controlled human infection model study (NCT03527173) enrolling healthy United States adults aged 18–50 years. report analyses evaluating immune responses to vaccination, with the aim identify...