A Single-centre, Before-After Study of the Short- and Long-term Efficacy of Narivent® in the Treatment of Nasal Congestion

Objective:Nasal congestion is a common symptom in allergic and nonallergic rhinitis, rhinosinusitis and nasal polyposis. The present study evaluated the clinical effectiveness of Narivent®, an osmo..

A phase 2a randomized study to evaluate the safety and immunogenicity of the 1790GAHB GMMA vaccine against Shigella sonnei administered intramuscularly to adults from a shigellosis-endemic country

Shigellosis is a mild-to-severe diarrheal infection caused by the genus Shigella and responsible for significant morbidity and mortality worldwide. We evaluated the safety and immunogenicity of an investigational Shigella sonnei vaccine (1790GAHB) based on Generalized Modules for Membrane Antigens (GMMA) in Kenya, a Shigella-endemic country. This phase 2a, observer-blind, controlled study (NCT02676895) enrolled and randomized 74 healthy adults aged 18–45 years, of whom 72 were vaccinated. Participants, randomized with a 1:1:1 ratio, received 2 vaccinations with the 1790GAHB vaccine at doses of either 1.5/25 μg of O antigen/protein (group 1.5/25 μg) or 5.9/100 μg (group 5.9/100 μg) at day [D] 1 and D29, or vaccination with a quadrivalent meningococcal vaccine at D1 and diphtheria, tetanus and acellular pertussis vaccine at D29 (control group). Solicited and unsolicited adverse events (AEs), serious AEs and AEs of special interest (neutropenia and reactive arthritis) were collected. Anti-S. sonnei LPS serum IgG geometric mean concentrations (GMC) were evaluated at D1, D29 and D57 and compared to anti-S. sonnei LPS antibody levels in convalescent patients naturally-exposed to S. sonnei. The percentages of participants with seroresponse were calculated. The most frequently reported solicited local and systemic AEs across all groups were pain and headache, respectively. Only 1 case of severe systemic reaction was reported (severe headache after first vaccination in group 5.9/100 µg). Ten cases of transient and asymptomatic neutropenia, assessed as probably or possibly related to vaccination, were recorded in 6 participants from all 3 groups. No other serious AEs were reported. Despite very high baseline anti-S. sonnei LPS serum IgG levels, the 1790GAHB vaccine induced robust antibody responses. At D29, GMC increased 2.10- and 4.43-fold from baseline in groups 1.5/25 µg and 5.9/100 µg, respectively, whereas no increase was observed in the control group. Antibody titers at D57 were not statistically different from those at D29. Seroresponse was 68% at D29 and 90% at D57 in group 1.5/25 μg, and 96% after each vaccination in group 5.9/100 μg. The 1790GAHB vaccine was well tolerated and, despite very high baseline antibody titers, elicited robust antibody response in a population of African adults, regardless of GMMA conten

A phase 2a randomized study to evaluate the safety and immunogenicity of the 1790GAHB GMMA vaccine against Shigella sonnei administered intramuscularly to adults from a shigellosis-endemic country

Shigellosis is a mild-to-severe diarrheal infection caused by the genus Shigella and responsible for significant morbidity and mortality worldwide. We evaluated the safety and immunogenicity of an investigational Shigella sonnei vaccine (1790GAHB) based on Generalized Modules for Membrane Antigens (GMMA) in Kenya, a Shigella-endemic country. This phase 2a, observer-blind, controlled study (NCT02676895) enrolled and randomized 74 healthy adults aged 18–45 years, of whom 72 were vaccinated. Participants, randomized with a 1:1:1 ratio, received 2 vaccinations with the 1790GAHB vaccine at doses of either 1.5/25 μg of O antigen/protein (group 1.5/25 μg) or 5.9/100 μg (group 5.9/100 μg) at day [D] 1 and D29, or vaccination with a quadrivalent meningococcal vaccine at D1 and diphtheria, tetanus and acellular pertussis vaccine at D29 (control group). Solicited and unsolicited adverse events (AEs), serious AEs and AEs of special interest (neutropenia and reactive arthritis) were collected. Anti-S. sonnei LPS serum IgG geometric mean concentrations (GMC) were evaluated at D1, D29 and D57 and compared to anti-S. sonnei LPS antibody levels in convalescent patients naturally-exposed to S. sonnei. The percentages of participants with seroresponse were calculated. The most frequently reported solicited local and systemic AEs across all groups were pain and headache, respectively. Only 1 case of severe systemic reaction was reported (severe headache after first vaccination in group 5.9/100 µg). Ten cases of transient and asymptomatic neutropenia, assessed as probably or possibly related to vaccination, were recorded in 6 participants from all 3 groups. No other serious AEs were reported. Despite very high baseline anti-S. sonnei LPS serum IgG levels, the 1790GAHB vaccine induced robust antibody responses. At D29, GMC increased 2.10- and 4.43-fold from baseline in groups 1.5/25 µg and 5.9/100 µg, respectively, whereas no increase was observed in the control group. Antibody titers at D57 were not statistically different from those at D29. Seroresponse was 68% at D29 and 90% at D57 in group 1.5/25 μg, and 96% after each vaccination in group 5.9/100 μg. The 1790GAHB vaccine was well tolerated and, despite very high baseline antibody titers, elicited robust antibody response in a population of African adults, regardless of GMMA conten

EULAR points to consider for the use of imaging to guide interventional procedures in patients with rheumatic and musculoskeletal diseases (RMDs)

Objectives To develop evidence-based Points to Consider (PtC) for the use of imaging modalities to guide interventional procedures in patients with rheumatic and musculoskeletal diseases (RMDs). Methods European Alliance of Associations for Rheumatology (EULAR) standardised operating procedures were followed. A systematic literature review was conducted to retrieve data on the role of imaging modalities including ultrasound (US), fluoroscopy, MRI, CT and fusion imaging to guide interventional procedures. Based on evidence and expert opinion, the task force (25 participants consisting of physicians, healthcare professionals and patients from 11 countries) developed PtC, with consensus obtained through voting. The final level of agreement was provided anonymously. Results A total of three overarching principles and six specific PtC were formulated. The task force recommends preference of imaging over palpation to guide targeted interventional procedures at peripheral joints, periarticular musculoskeletal structures, nerves and the spine. While US is the favoured imaging technique for peripheral joints and nerves, the choice of the imaging method for the spine and sacroiliac joints has to be individualised according to the target, procedure, expertise, availability and radiation exposure. All imaging guided interventions should be performed by a trained specialist using appropriate operational procedures, settings and assistance by technical personnel. Conclusion These are the first EULAR PtC to provide guidance on the role of imaging to guide interventional procedures in patients with RMDs