Ebola Virus Disease

Researchers are studying the safety and immune response of the rVSV6G-MARV-GP vaccine in adults who are in good general health. This Phase 1 clinical trial uses a randomized, observer-blind, placebo-controlled design to evaluate different dose levels of the vaccine. The study focuses on understanding how the vaccine affects the body and its ability to trigger an immune response against Marburg Virus Disease. Participants will receive one of four different dose levels of the rVSV6G-MARV-GP vaccine or a placebo. The dosing starts at the lowest level and gradually increases after safety checks at each stage. About 112 adults will be involved, and the vaccine or placebo will be given following a careful dose-escalation plan to ensure safety at each step. During the study, participants will be monitored closely for safety, including common side effects and serious adverse events up to seven months after vaccination. Their immune response will be measured through blood tests over six months to assess antibody levels and neutralization. The trial includes regular follow-up visits and testing, with a total participation duration extending up to several months to evaluate both short and longer-term effects of the vaccine.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are studying how the COVID-19 pandemic affects alcohol use and its consequences in people with varying levels of alcohol consumption, including those with alcohol use disorder. The study also looks at changes over time in stress, social isolation, and negative life events related to the pandemic, as well as factors like anxiety, depression, and craving. This observational research aims to understand these impacts over a 2-3 year period during and after the pandemic. Participants who previously enrolled in an NIAAA natural history protocol will complete surveys by phone and online. The study is divided into phases: initially, participants complete weekly to bimonthly surveys over the first year, then every six months during the second year. After September 2023, surveys will continue at 1 to 3-month intervals for up to three more years. Surveys cover alcohol use, consequences, other substance use, stress, pain, physical health, sleep, and quality of life. Throughout the study, participants provide responses to questionnaires assessing alcohol use disorder symptoms and life stressors. Researchers monitor scores such as the AUDIT and ADS over 24 months. Participants provide data on loneliness, perceived stress, and life events. The study lasts approximately two years in the first phase, with an optional extension. Participants complete surveys regularly and can expect ongoing monitoring of their experiences related to alcohol and mental health during the pandemic.

Researchers are evaluating a new health education method aimed at helping indigenous Orang Asli households in Selangor, Malaysia, prepare for Disease X and other outbreaks. This cluster randomized trial seeks to find out if a package including workshops, simulation exercises, and card games can improve these households' readiness, awareness, attitudes, and proactive preparedness actions compared to receiving educational brochures alone. The study compares two groups: one receiving the intervention package plus educational brochures, and the other receiving only the brochures. The intervention package is delivered once during a workshop. The control group gets brochures sourced from the Ministry of Health Malaysia's "Info Sihat" website. Both groups will participate in surveys before the intervention, immediately after, and at 1- and 2-month follow-ups to assess changes. Participants will engage in the intervention activities or receive brochures, then complete four surveys to measure preparedness using scores and matrices. Researchers will track household preparedness, cognitive preparedness, and behavior related to outbreak readiness over the two-month follow-up. The study is sponsored by Universiti Teknologi Mara and includes adults aged 18 to 99 years old from Orang Asli communities.

Researchers are investigating vector-borne diseases, which are infections caused by bites from mosquitoes, flies, fleas, ticks, or other blood-feeding insects. These diseases contribute to nearly one million deaths annually and are increasing, especially in Southeast Asia. This study aims to better understand these illnesses in Cambodia, where they may account for about 10% of fevers, by identifying pathogens using advanced metagenomic sequencing techniques. Participants include people aged 2 months to 65 years who have a fever of at least 38 degrees Celsius or have been diagnosed with important infectious pathogens. Close contacts of infected individuals may also join. Participants provide information about their health, travel, sex, age, and residence. Blood samples are collected, and nasal swabs are taken if respiratory symptoms are present. Optional follow-up blood samples and nasal swabs may be taken within 1-2 weeks and/or up to 3 months after enrollment. During the study, participants complete questionnaires and undergo medical history screening. Children are weighed to ensure suitability for blood sampling. The researchers will analyze pathogen sequences from samples collected between day 0 and 2 of enrollment and assess immune reactions to insect saliva. This study includes long-term tracking through optional follow-up samples to better understand disease spread and impact in the region.

Researchers are evaluating how experiencing awe influences adults' willingness to engage in prosocial preventive behaviors against infectious diseases. This randomized controlled trial includes adults from Hong Kong, Singapore, and ten major cities in Mainland China. The study aims to find out if feeling awe can increase intentions for actions like vaccination, mask-wearing, and social distancing, and whether these effects differ by location. Participants will be randomly assigned to one of two groups. The intervention group will play a three-step mini game called Hidden Picture Puzzle designed to induce awe by revealing nature scenes and reflecting on feelings evoked. The control group will play the same game format but will uncover everyday objects and describe their features instead. Each participant will complete four rounds of the game with different images. During the study, participants will complete the game and immediately report their intentions to engage in preventive behaviors and their choices in pandemic-related scenarios. The study will also assess intentions to participate in social activities after the game. The trial is conducted online, and participants had a baseline assessment about four months before the trial. The research team will monitor responses immediately after the game to measure the impact of awe on prosocial behavior.

Researchers are conducting a national, multicenter prospective study to understand how genetic defects and autoantibodies against type I interferons (IFNs) affect the immune response to infections, especially severe viral diseases like COVID-19. This study focuses on adults who either have inborn errors of immunity (IEI) impairing type I IFN responses or carry neutralizing autoantibodies against type I IFNs, which have been linked to severe illness and increased mortality in COVID-19. The aim is to track infectious, autoimmune, and cancer-related events to improve prevention and management strategies for these patients. The study includes adults with these immune characteristics who may be patients with past or current disease or healthy individuals such as blood donors or relatives of affected patients. Participants will have yearly visits to clinical centers for blood sampling and medical history updates, including investigations of immune markers, autoantibodies, and genetic analyses. Additional visits occur if participants experience infections, autoimmune flare-ups, cancer diagnoses, or COVID-19 infections, with detailed blood tests and teleconsultations. Controls without these immune abnormalities will be matched and followed through questionnaires and health data linkage. Participants undergo an initial visit to collect demographic information, medical and family history, and blood samples for detailed immune and genetic tests, including whole-exome or whole-genome sequencing. Follow-up visits occur annually for up to four years, involving clinical assessments and blood sampling to measure autoantibody levels and immune function. Clinical events and healthcare use will be tracked through national health data, and the main outcomes include measuring autoantibody levels and their neutralizing activity over time. This long-term monitoring aims to reveal factors influencing disease risk and immune changes in this population.

Researchers are conducting a national observational study to understand bacterial meningitis in children and newborns. This study focuses on the bacteria that cause meningitis, how vaccination has influenced its occurrence, and the treatment outcomes in children under 18 who are hospitalized with this condition. The goal is to describe the changing epidemiology of bacterial meningitis, especially in the context of vaccine use. The study collects detailed data on hospitalized children including risk factors, vaccination status, symptoms, and treatments given during hospital stays. Laboratory analyses such as cerebrospinal fluid cultures, antigen tests, blood cultures, and PCR are used to identify the bacteria involved. The study also tracks cases of purpura fulminans, a serious complication related to bacterial infections. Participants will be monitored during their hospital stay with focus on mortality before discharge, treatment failures 48 hours after antibiotics and repeat lumbar puncture, and the impact of vaccines. Data on clinical signs and laboratory results are collected to support the study. The study began in 2001 and continues to gather information to improve understanding of bacterial meningitis in this population.

Researchers are investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups: pre-operative chlorhexidine mouthwash combined with high oxygen levels (80-100% FiO2), no mouthwash with high oxygen levels, mouthwash with low oxygen levels (21-30% FiO2), or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.

Inappropriate antibiotic prescribing in primary care contributes to antimicrobial resistance, especially when antibiotics are used for infections that usually resolve on their own. This research aims to evaluate a digital Prescription Support System (PSS) designed to help general practitioners in Belgium follow national guidelines for antimicrobial use during patient visits. The study uses a stepped-wedge cluster randomized design where general practices transition from usual care to using the PSS over four steps. The PSS integrates the Belgian BAPCOC guidelines into a user-friendly decision tree within electronic health records. It provides recommendations on antibiotic choice, dosage, duration, and when antibiotics are not needed for common infections seen in ambulatory care. Practices start with usual care and then sequentially gain access to the PSS, maintaining use for the remainder of the study. This digital tool aims to support prescribing decisions during routine consultations. Participants include general practices that use compatible electronic health records and consent to participate. The study monitors antibiotic prescribing rates quarterly using data from the Belgian Antibiotic Barometer for up to 12 months per practice. Researchers also assess the PSS's usability, acceptability, intensity of use, and any unintended effects reported by clinicians or observed in system data. Data privacy is ensured through pseudonymization and secure handling. Results will guide future improvements and broader implementation of the PSS in Belgian primary care.