Kilifi

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Diarrhoea caused by Shigella sonnei, known as shigellosis, is a significant public health concern, especially in regions where the disease is common. There are currently no licensed vaccines routinely available for Shigella, but several candidates are in clinical development. Researchers are conducting this Phase 1 study in Kenyan adults to establish a controlled human infection model using Shigella sonnei 53G. The goal is to find the bacterial dose that safely causes shigellosis in at least 60% of healthy volunteers, which will help accelerate vaccine development and improve understanding of immune responses and factors affecting susceptibility to infection. The study has two phases over 12 to 14 months. Phase A is a dose-finding phase with up to 40 volunteers who will receive varying doses of lyophilized Shigella sonnei 53G bacteria, starting at 1,500 colony-forming units (CFU). The dose will be adjusted up or down by 500 CFU based on the attack rate observed until the optimal dose causing at least 60% infection is found or safety concerns arise. Phase B will enroll about 30 volunteers to confirm the reproducibility of the infection rate using the selected dose. Volunteers may also receive ciprofloxacin treatment (500 mg orally twice daily for three days) as part of the study. Participants will stay as inpatients for about 12 days after receiving the bacterial challenge and will be followed as outpatients for approximately 12 months. During the study, researchers will monitor for adverse events and measure the attack rate of shigellosis. Assessments include clinical monitoring, laboratory tests, and evaluation of immune responses. Safety is closely observed, and volunteers must be available for all follow-up visits. The study aims to optimize the dose for infection success and verify the safety and feasibility of this human infection model in Kenyan adults.