Dengue Fever

This research aims to develop a safe controlled human infection model for dengue fever using an attenuated dengue virus serotype 3 DEN3 in adult volunteers aged 21 to 45 years. It will analyze the clinical, viral, and immune responses to better understand dengue fevers pathophysiology. The study is designed to establish a reproducible infection in at least 80% of participants and to provide data to support future vaccine and treatment studies, including a planned follow-up dengue vaccine efficacy trial. Participants will receive a subcutaneous injection of a GMP-produced rDEN3delta30 virus, which is an attenuated form of the dengue virus developed by the National Institutes of Health. The study will monitor infection and immune responses in detail, including clinical symptoms, blood tests, and immune profiling. The challenge virus dose and safety protocols are based on prior studies conducted in the US. The study includes a quarantine period and follow-up evaluations to track viral kinetics and immune markers. During the study, participants will undergo regular clinical assessments, laboratory tests including blood samples, and safety monitoring from the day of viral challenge through at least 28 days post-inoculation, with longer-term immune response follow-up lasting up to three years. Researchers will measure occurrence and severity of adverse events, infection rates, viral load, symptom severity, and immune responses. The study requires contraception use during and after the trial for safety. Participation involves quarantine and multiple visits to collect data on dengue infection and immune responses.

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 drugs 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 strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are studying the effectiveness of a tetravalent dengue vaccine TDV in reducing hospital stays due to dengue in children and adolescents aged 6 to 12 years living in Southeast Asian countries with high dengue transmission, including Thailand, Indonesia, and Malaysia. This observational study focuses on participants in a community-based cohort who may or may not receive the vaccine as part of a pilot public vaccination program where TDV is already approved. The study particularly aims to assess the vaccines effectiveness against less common dengue virus types DENV-3 and DENV-4. The study includes a nested case-control design with two groups cases who are hospitalized children or adolescents with confirmed dengue infection, and matched controls who live in the same neighborhood but have not been hospitalized with dengue. Participants are followed individually for up to 3 years within the cohort. The study is non-interventional, observing outcomes based on vaccination status within the existing vaccination program. Participants will be monitored through active hospital surveillance to identify dengue hospitalizations confirmed by laboratory testing. Data collected includes blood samples for RT-PCR testing, clinical diagnosis, and hospitalization records. Researchers will measure the rate of hospitalization due to dengue virus infections by serotype and baseline dengue immune status. The primary outcome is dengue-related hospitalization up to 36 months. Parents or legal representatives provide consent and assent for participants, including agreement for blood sample collection and follow-up over the study period.

Dengue fever is caused by infection with the dengue virus. This trial studies how safe and effective the Dengue Tetravalent Vaccine TDV is in activating the immune system of young children aged 6 to 21 months. The study aims to better understand the vaccines safety and immune response in infants and toddlers. Children will receive two doses of either TDV or a placebo injection, given three months apart. Participants are divided into two age groups 6 to less than 12 months and 12 to less than 21 months. Each group receives either the vaccine or placebo through subcutaneous injections on Day 1 and Day 90. Participants will visit the clinic eight times for vaccinations, blood draws, and health checks throughout the study. Blood samples are collected before and after vaccination to assess immune response. Researchers will monitor adverse events, immune responses, and overall health during the study, which continues until the final assessments at Day 1170.

Researchers are conducting a randomized, double-blind, placebo-controlled Phase 23 trial to assess the efficacy, safety, and antiviral effects of CP-COV03 in adults infected with dengue. The study aims to compare different doses of CP-COV03 against a placebo in patients diagnosed with dengue or dengue-like illnesses, including zika, influenza, and COVID-19. The trial is sponsored by Hyundai Bioscience Co., Ltd. and focuses on treatment outcomes in this population. In Phase 2, about 210 patients with NS1-positive dengue within 72 hours of fever onset will be randomly assigned to receive either placebo or CP-COV03 at doses of 450 mg, 900 mg, or 1,350 mg per day for 7 days. An independent Data and Safety Monitoring Board will conduct an interim analysis to guide dose selection for Phase 3. The study involves oral administration of the drug and includes separate groups for each dose as well as a matching placebo group. Participants will be monitored for adverse events and changes in dengue viral load from baseline through Day 29, with viral load assessments on Days 1, 2, 3, 6, 8, and 15. Symptom improvement will be tracked up to Day 15. Pharmacokinetic parameters of the drug will also be measured on Days 1 and 7. Safety follow-up continues until Day 29. The total participation duration varies according to these assessments and treatment schedules.

Dengue fever is a viral infection that can affect adults and elderly people, especially in areas where dengue is common. Researchers are studying the Dengue Tetravalent Vaccine TDV in adults aged 45 to 60 years and elderly adults aged over 60 to 79 years. The study aims to understand the side effects of TDV and how well it triggers an immune response, including in those with other health conditions like diabetes, high blood pressure, or kidney disease. Participants will receive two injections of TDV or a placebo during the study, with the second dose given three months after the first. Adults aged 45 to 60 years will receive TDV openly, while elderly participants over 60 will be randomly assigned to receive either TDV or a placebo. Injections are given under the skin, and the study is conducted in multiple centers. Throughout the study, participants will visit the clinic five times for monitoring. Researchers will check for local and systemic side effects shortly after each vaccination, assess antibody levels against the dengue virus, and monitor for any serious health events. The study will continue for up to nine months to observe safety and immune responses in all participants.

Researchers are evaluating the effects of EYU688, an oral drug, compared with a placebo in patients with dengue fever. The study aims to understand how EYU688 influences dengue viral load, fever clearance time, and clinical symptoms. This randomized, participant- and investigator-blinded, placebo-controlled trial includes two patient groups based on different pharmacokinetic sampling schedules. Participants will receive either EYU688 or a matching placebo orally. The study runs two cohorts in parallel one with intensive pharmacokinetic sampling and another with sparse sampling. Treatment and assessments occur from the start of dosing through Day 15, with additional safety monitoring up to Day 35. The study measures drug concentration levels and viral load changes over time. Throughout the study, participants will undergo evaluations including viral load tests, fever monitoring, blood tests for blood cells and liver enzymes, and assessments for dengue severity. Safety and adverse events are recorded up to Day 35. The primary outcome is viral load reduction at 48 hours after treatment begins. Participation lasts until study completion, expected by July 2027.

Researchers are evaluating the antiviral effects of several experimental drugs in patients with early dengue infection, defined as those with confirmed dengue and less than 48 hours of fever. This adaptive platform trial aims to determine how well these drugs work against the dengue virus and assess their safety and tolerability. The study also explores how these drugs affect various physiological and clinical markers in dengue patients. Participants are randomly assigned to one of four groups standard care with no study drug, molnupiravir taken orally twice daily for five days, a single intravenous dose of a dengue monoclonal antibody called VIS513, or remdesivir dosed according to weight over five days. The trial is open-label and adaptive, allowing for the addition of new treatments or removal of less effective ones based on ongoing results. During the trial, participants will be monitored from randomization through day 5 for viral clearance and safety, with further follow-up visits at 30 and 60 days after enrollment. Researchers will assess virus levels, fever duration, clinical progression, and laboratory measures such as platelet count and liver enzymes. Safety events and adverse effects are also tracked up to 30 days post-enrollment to ensure participant well-being throughout the study.

Researchers are conducting an international observational study to understand acute infectious diseases in adults hospitalized with suspected or confirmed infections. This study aims to collect data and biospecimens from patients worldwide to characterize respiratory and non-respiratory infections, established infectious diseases, and emerging infectious diseases. The information gathered will help identify risk factors, clinical features, and management strategies, and guide future clinical trials. Participants in this study are adults admitted to a hospital with an acute infection or suspected infection. There is no intervention or treatment given as part of the study since it is observational. The study focuses on collecting clinical data and biospecimens during hospitalization to better understand the disease processes and outcomes. During the study, participants will be monitored for clinical outcomes such as mortality at 28 days, time to recovery, clinical improvement, organ support requirements, and organ failure scores. Data collection includes clinical assessments and biospecimen sampling. The study will continue until June 2027, with participants followed for outcomes mainly up to 28 days after enrollment. This observational approach supports the development of future clinical trials by providing detailed insights into acute infections.