Kilifi

Respiratory syncytial virus RSV is a common virus affecting children, especially young babies, premature infants, and those with heart or lung problems. It is a leading cause of hospitalization for children under 5 years old globally, with many severe cases and deaths occurring in low- and middle-income countries. This research evaluates the safety of an RSV vaccine called ABRYSVO given to pregnant women and how well it protects their infants from severe RSV infections during the first six months of life, particularly in African and lower-middle income countries where data is limited. Pregnant women will receive either the ABRYSVO vaccine or a placebo in a randomized, double-blind trial. The vaccine contains stabilized RSV prefusion F antigens from virus subgroups A and B. The study will enroll pregnant women at the approved gestational age for vaccination, with participants randomly assigned to receive either the vaccine or placebo in equal numbers. The trial will monitor the safety of the vaccine in mothers and infants and measure how well the vaccine prevents severe RSV lower respiratory tract infections in babies up to 180 days old. Participants will attend antenatal clinics and provide informed consent for themselves and their infants. Researchers will follow the women through pregnancy and delivery, recording any preterm births and birth weights. Infants will be monitored for RSV infections confirmed by laboratory tests, and hospitalizations due to RSV will be tracked up to six months of age. Safety assessments include monitoring adverse events in mothers and babies, with follow-up visits and telephone contacts to ensure comprehensive data collection throughout the trial period.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Diarrhea caused by Shigella, known as shigellosis, is a significant public health concern with no licensed vaccines currently in routine use. Researchers are establishing a human infection study HIS using Shigella sonnei 53G in Kenyan adults to help develop a vaccine model and better understand immune responses and factors influencing disease susceptibility. This study is a Phase 1 trial involving dose-finding and dose-verification phases to achieve about a 60% infection rate safely. The study involves two phases over 12 to 14 months. Phase A will enroll up to 40 volunteers receiving varying doses of lyophilized Shigella sonnei 53G bacteria to find the dose causing infection in at least 60% of participants. Depending on infection rates, doses may increase or decrease by 500 CFU in subsequent groups. Phase B will enroll 30 volunteers to confirm the infection rate with the selected dose. All participants will receive curative treatment with Ciprofloxacin after challenge. Participants will stay as inpatients for about 12 days and have outpatient follow-up for approximately 12 months. Researchers will monitor adverse events, infection rates, bacterial shedding, and antibody responses over time. Safety and infection success are primary outcomes. Volunteers will undergo regular assessments during the study, including laboratory tests and close monitoring of symptoms and immune responses to understand Shigella infection better.