Rabies

Researchers are conducting a Phase 1 clinical trial to study a freeze-dried human rabies vaccine made from human diploid cells. This trial aims to evaluate the safety and tolerability of this vaccine in participants aged 10 to 60 years. The study is designed as a single-arm, randomized, and open-label trial, enrolling 60 participants split evenly between younger (10-17 years) and adult (18-60 years) age groups. The trial compares two different immunization schedules to assess their effects. Participants in the adult group are randomly assigned to receive either a 5-dose schedule with vaccine doses on days 0, 3, 7, 14, and 28, or a 2-1-1 schedule with doses on day 0 (two doses), day 7, and day 21. Safety is closely monitored for seven days after the first dose in the adult group. After confirming safety, the younger group follows the same randomization and dosing schedules. Vaccinations are given by intramuscular injection. Throughout the study, researchers collect information on any adverse events occurring from the first dose through 30 days after completing the full vaccination. Serious adverse events and pregnancy-related outcomes are monitored for six months after vaccination completion. Safety assessments include monitoring reactions within 30 minutes and 7 days after each dose, laboratory tests on the third day after the first dose, and ongoing observations for serious events. The total duration of participation includes vaccination and follow-up safety monitoring.

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 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 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.

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.

Researchers are evaluating whether faster testing for respiratory viruses like Influenza, COVID-19, and Respiratory Syncytial Virus (RSV) can reduce the number and size of virus outbreaks in long-term care homes. The trial compares rapid point-of-care testing with existing laboratory testing methods to see if quicker results help control virus spread among residents. This study is led by Michael Garron Hospital and involves long-term care facilities linked to specific Ontario Health Teams. The study involves two groups: one uses a point-of-care respiratory test platform located within the care facility to provide quick test results, while the other group continues using the existing respiratory virus testing platforms. The rapid testing device aims to deliver results faster than traditional lab methods, potentially allowing for timely infection control measures. The study is randomized and does not include blinding. Participants are long-term care residents in facilities engaged with Ontario Health Teams overseen by Sunnybrook Health Science Centre, Michael Garron Hospital, or Humber River Health. Researchers will track the number of residents infected with the targeted viruses over seven months, along with outbreak frequency, hospital transfers, deaths, outbreak duration, and secondary attack rates. No study blinding is used, and the trial runs until March 2026, monitoring outcomes at various intervals from 14 days to 60 days depending on the measure.

Researchers are investigating the virologic and immunologic aspects of HIV infection, as well as other infectious and non-infectious immune deficiency diseases, to better understand the disease process of HIV. Due to the lack of suitable animal models, this research uses human peripheral blood cells to study HIV infection both inside the body and in laboratory settings. The goal is to clarify how HIV interacts with immune regulation and dysregulation using human peripheral blood mononuclear cells as a model. This observational study involves groups of people living with or without HIV, those with or without infectious diseases of interest, and individuals with or without immunodeficiencies. The study collects blood products and other biological samples to support various research projects conducted by NIH investigators. These samples will be used throughout the study to analyze HIV and immune-related parameters. Participants provide blood samples and undergo health assessments including blood pressure, pulse, and blood counts. They agree to blood being used for current and future research on HIV infection and pathogenesis, including hepatitis screening. The study measures genomic and proteomic properties of samples from individuals with HIV, infectious diseases, and immunodeficiencies, compared to healthy volunteers. Participation involves ongoing sample collection and monitoring by the NIH research team.