NIH clinical examination analyzes the dengi research therapy

Clinical examination supported by the National Institutes of Health (NIH) testing experimental treatment little to help people suffering from dengi, viral disease transmitted by mosquitoes. The study is supported by the NIH National Institute of Allergy and Infectious disease (NIAID) and will require the exposure of adult volunteers to a weakened dengi virus strain, which causes a mild form of disease and administration of therapeutics tests at various doses to assess its safety in order to assess its safety in the purpose of assessing his safety to assess his safety in order to assess the safety of his safety and the ability to reduce symptoms.

According to American control centers and prevention of dengue diseases, as many as 400 million people are passed through infected mosquitoes and patients, mainly in tropical and subtropical parts of the world. In 2024, the cases of Dengi increased to a record level in the Americas with a local transmission in the US reported in Arizona, California, Florida, Hawaii and Texas. Denga is endemic in Puerto Rico, which reported almost 1,500 cases last year. Most people with denga do not develop symptoms, but those who often experience severe headache and body pain, nausea and vomiting, fever and rash. One in 20 people who get sick from dengi, develops in a serious illness, which can lead to shock, internal bleeding and death. Currently, there is no drug approved by food and administration for dengue.

When taking care of a patient who is critically ill from the dengue, the healthcare providers have few options than providing supporting care. We need to find safe and effective therapeutics to ensure very necessary relief for people suffering from dengue. “

Development of Marrazzo, MD, MD, director of NIAID

The new clinical trial will test the ability of AV-1, human therapeutic monoclonal antibody research developed by Abviro (Bethesda, Maryland), to mitigate clinical symptoms after administration before and after infection of the dengi virus. The results of the previously completed phase 1 study supported by Niaid indicated that AV-1 is safe in humans, constituting the basis of a new clinical trial to test its safety and effectiveness.

Phase 2 clinical trials will be recorded at least 84 healthy adult volunteers in two places: Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore and the Vermont -Burington vaccine test center in Burlington. After the initial study and physical examination, volunteers will be randomly assigned to one of two groups. One group will receive AV-1 one day before the challenge with a mild Dengi virus strain, and the other will receive AV-1 four days after questioning the Dengi virus. Each group will be further divided to receive 100 mg, 300 mg or 900 mg AV-1, supplied in a 60-minute intravenous infusion. For each of the three dosage levels, 12 participants will receive the monoclonal antibodies, and two will receive placebo.

Before administering AV-1 or after AV-1, each volunteer will receive an injection of a weakened (weakened) dengi virus. In earlier studies using this virus challenges, most volunteers developed a rash, and some had other mild dengue symptoms, such as joint and muscle pain or headache. None of the volunteers developed a dengue fever or heavy dengi.

Volunteers will participate in regular check -ups with research staff for at least 155 days to thoroughly monitor the effects of the monoclonal antibody tested. Through physical examinations, diary cards and blood samples, scientists have a document, how the volunteers’ immune system react to the challenge of the Dengi virus, how quickly the virus disappears from the bloodstream and all symptoms that they can experience. Scientists will use this information to determine how AV-1 affects the volunteers’ ability to recover from dengi compared to placebo and to determine the doses at which AV-1 can be effective.

If AV-1 has promising results in this clinical trial, scientists can implement further clinical assessments of its safety and effectiveness against the Dengi virus. For more information about the study, visit clinicaltls.gov and search the NCT05048875 ID.

Niaid conducts and supports research-in Nih, in the United States and around the world-to examine the causes of infectious and immune diseases and develop better means of preventing, diagnosing and treating these diseases. Messages, facts sheets and other NIAID materials are available on the NIAID website.