Press release
Tuesday February 11, 2025
A clinical trial supported by the National Institutes of Health (NIH) is testing an experimental treatment designed to help people suffering from the effects of dengue, a viral disease transmitted by mosquitoes. The study is supported by the National Institute of Infectious Allergies and Diseases of NIH (NIAID), and will imply exposing adult volunteers to a weakened strain of dengue virus which causes a light form of the disease and Administer an investigation therapy at various doses to assess its safety and ability to reduce symptoms.
Dengue is transmitted via infected Cashier Mosquitoes and patients up to 400 million people each year, mainly in tropical and subtropical parts of the world, according to the centers for Disease Control and Prevention. In 2024, dengue cases reached record levels in the Americas with the local transmission of the United States reported in Arizona, California, Florida, Hawaii and Texas. Dengue is endemic to Puerto Rico, which brought in nearly 1,500 cases last year. Most people with dengue do not develop symptoms, but those who generally experience serious headaches and bodily ailments, nausea and vomiting, fever and treatment. One in 20 person who falls ill from dengue is progressing towards a serious illness, which can lead to shock, internal bleeding and death. There is currently no treatment approved by the Food and Drug Administration for Dengue.
“When taking care of a patient who is seriously ill from dengue, health care providers have few options other than providing support,” said Niaid director Jeanne Marrazzo, MD, MPH “We have to find safe and effective therapies to provide essential relief for people with dengue. »»
The new clinical trial will test the capacity of AV-1, a human monoclonal antibody studied therapeutic developed by Abviro (Bethesda, Maryland), to alleviate clinical symptoms when administered before and after infection by the dengue virus . The results of a previously supported Niaid Phase 1 test said that Ad-1 is sure in humans, providing the basis of the new clinical trial to test its safety and efficiency.
The phase 2 clinical trial will register at least 84 healthy adult volunteers on two sites: the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore and the Vaccination Test Center of the University of Vermont in Burlington . After initial screening and physical examination, volunteers will be randomly assigned to one of the two groups. A group will receive AV-1 one day before being challenged with a slight strain of dengue virus, and the other will receive BC four days after being challenged with the dengue virus. Each group will still be subdivided to receive 100 mg, 300 mg or 900 mg of AV-1, delivered in an intravenous infusion of 60 minutes. For each of the three dosage levels, 12 participants will receive the monoclonal investigation antibody and two will receive a placebo.
Before or after the AV-1 dosage, each volunteer will receive an injection of attenuated (weakened) virus of dengue. In previous studies using this challenge virus, most volunteers have developed a rash and some had other light dengue symptoms, such as joint and muscular pain or headache. None of the volunteers have developed dengue or severe dengue.
Volunteers will participate in regular follow -up visits with study staff for at least 155 days to carefully monitor the effects of the monoclonal antibody sought. Thanks to physical examinations, newspaper cards and blood samples, researchers will document how the volunteer immune systems react to the dengue virus challenge, how speed the virus disappears from their blood circulation and all the symptoms that They can feel. Researchers will use this information to determine how AV-1 affects the ability of volunteers to recover from dengue in relation to placebo and determine the doses to which BC can be effective.
If AV-1 shows promising results in this clinical trial, researchers can pursue additional clinical assessments of its safety and efficiency against the dengue virus. For more information on the study, visit Clinicaltrials.gov and search for the identifier NCT05048875.
Niaid conducts and supports research – in NIH, the United States and the world – to study the causes of infectious and immune mediation, and to develop better means of prevention, diagnosis and treatment of these diseases. Press releases, information sheets and other Niaid materials are available on the Niaid website.
On the National Institutes of Health (NIH):The NIH, the country’s medical research agency, includes 27 institutes and centers and is a component of the American department of health and social services. NIH is the main federal agency that leads and supports basic, clinical and translational medical research, and studies the causes, treatments and remedies for common and rare diseases. For more information on NIH and its programs, visit www.nih.gov.
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