Kintampo

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.

Researchers are evaluating the long-term safety and effects of etavopivat, a new oral medicine being developed for inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein responsible for carrying oxygen in the blood. This phase 3 study involves participants who have already completed treatment in a prior etavopivat study and aims to understand how etavopivat performs over an extended period of up to 264 weeks, though the study may end earlier if the drug gains approval locally. Participants will receive oral doses of etavopivat, with different forms A, B, or C given based on their age and condition. Those aged 12 years and older will receive etavopivat A or C, while children under 12 years will receive etavopivat B. The study includes several groups covering various sickle cell disease and thalassaemia categories, including transfusion-dependent and non-transfusion-dependent cases. Treatment is continuous during the study period. Throughout the study, participants will undergo regular monitoring for side effects and treatment responses, including tracking treatment emergent adverse events, hospitalizations, vaso-occlusive crises, hemoglobin concentration changes, and blood transfusion needs. These assessments will help evaluate the drugs safety and efficacy across age groups and disease types. The study is open-label and non-randomized, with follow-up lasting up to about six years.

Researchers are evaluating the effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

Researchers are evaluating how well different anti-malarial drugs work and how safe they are for treating uncomplicated Plasmodium falciparum malaria in adults, adolescents, and children. This study focuses on the parasite-killing effects and potential cure rates of these drugs when given alone or combined with others. It also looks at how the drugs are processed by the body to help decide doses for future studies. Participants will receive one of several treatments, including varying doses of the oral drug INE963, combinations of oral KAE609 Cipargamin with INE963 or KLU156, or the standard of care drug Coartem. The study has multiple parts with patients allocated randomly to different treatment groups. Dosing levels and combinations are tested to compare how effectively they clear the malaria parasite. During the study, participants will have their parasite levels monitored up to 7 days and clinical response assessed by day 29. Blood samples will be taken by day 22 to study drug levels and how the body absorbs and clears the medicines. Safety is monitored through reports of side effects until day 43. The total participation lasts through these assessments to understand treatment impact and tolerability.

Access to quality antenatal and postnatal care is crucial to reducing pregnancy-related health problems and supporting positive birth experiences. Despite World Health Organization recommendations for eight antenatal visits, coverage and quality of care remain inconsistent, especially in vulnerable populations and resource-poor regions. This study aims to evaluate pregnancy risk factors and their links to adverse outcomes like stillbirth, neonatal mortality, and maternal morbidity in low- and middle-income countries to help improve maternal and newborn health. The study follows a large open cohort design to gather harmonized data on maternal and newborn health from multiple centers. It observes pregnant women from early pregnancy under 20 weeks gestation through delivery and postpartum periods, focusing on risk factors and outcomes without providing specific treatments. The research collects information on maternal mortality, severe maternal outcomes, anemia, stillbirth, neonatal mortality, preterm birth, low birth weight, and small-for-gestational-age infants. Participants will be monitored from pregnancy identification around 10-20 weeks gestation through delivery and up to one year postpartum. Assessments include maternal and infant health outcomes measured at various timepoints such as delivery, 42 days postpartum, and up to 12 months after birth. The study tracks important maternal and infant conditions, including infections, hypertension, diabetes, depression, and infant growth, aiming to better understand risks and inform future care strategies.

Researchers are evaluating the RTS,SAS01 malaria vaccine through case-control studies embedded within the Malaria Vaccine Pilot Evaluation MVPE conducted in Ghana, Malawi, and Kenya. This observational study aims to assess the vaccines safety with focus on cerebral malaria, meningitis, and severe malaria, as well as its impact on all-cause mortality among children aged 6 months to 59 months. The study also supports the use of case-control methods in immunization and malaria control programs. The study involves two main case-control components clinical outcomes and mortality outcomes. For clinical outcomes, children living in MVPE areas who meet case or control definitions based on hospital surveillance are recruited, with each case matched to four controls. The mortality component recruits children who died from any cause excluding accidents or trauma and matches them with four live controls. Data collection includes administering questionnaires to caregivers at their homes and gathering information from hospital and community surveillance systems. Participants will be involved through consented data collection via questionnaires and surveillance records. Data on meningitis, severe malaria, cerebral malaria, and mortality by gender are collected and analyzed. Controls are recruited by canvassing households near cases to match age and location. The study spans 45 months, with ongoing monitoring of outcomes including hospital admissions and deaths. Findings will support vaccine safety and effectiveness assessments and inform policy decisions.