NIH-supported clinical trial to test experimental treatment for dengue

A scientific trial supported by the Nationwide Institutes of Well being (NIH) is testing an experimental remedy designed to assist folks struggling the results of dengue, a mosquito-borne viral illness. The research is supported by NIH’s Nationwide Institute of Allergy and Infectious Ailments (NIAID), and can contain exposing grownup volunteers to a weakened pressure of dengue virus that causes a light type of the illness and administering an investigational therapeutic at varied doses to evaluate its security and talent to reduce signs.

Dengue is transmitted through contaminated Aedes mosquitoes and sickens as many as 400 million folks annually, primarily in tropical and subtropical elements of the world, in line with the U.S. Facilities for Illness Management and Prevention. In 2024, dengue instances surged to document ranges within the Americas with native U.S. transmission reported in Arizona, California, Florida, Hawaii, and Texas. Dengue is endemic in Puerto Rico, which reported practically 1,500 instances final 12 months. Most individuals with dengue don’t develop signs, however those that do generally expertise extreme headache and physique aches, nausea and vomiting, fever and rash. One in 20 individuals who get sick with dengue progress to extreme sickness, which can result in shock, inside bleeding, and loss of life. There’s at the moment no Meals and Drug Administration-approved remedy for dengue. 

When caring for a affected person who’s critically ailing with dengue, healthcare suppliers have few choices aside from offering supportive care. We should discover protected and efficient therapeutics to supply much-needed reduction to folks affected by dengue.”

Jeanne Marrazzo, M.D., M.P.H., NIAID Director 

The brand new scientific trial will take a look at the power of AV-1, an investigational human monoclonal antibody therapeutic developed by AbViro (Bethesda, Maryland), to mitigate scientific signs when administered earlier than and after dengue virus an infection. The outcomes of a beforehand accomplished NIAID-supported Part 1 trial indicated that AV-1 is protected in people, offering the premise for the brand new scientific trial to check its security and efficacy. 

The Part 2 scientific trial will enroll at the very least 84 wholesome grownup volunteers at two websites: the Johns Hopkins Bloomberg College of Public Well being Middle for Immunization Analysis in Baltimore, and the College of Vermont Vaccine Testing Middle in Burlington. Following an preliminary screening and bodily examination, volunteers can be randomly assigned to one in every of two teams. One group will obtain AV-1 someday previous to being challenged with a light pressure of dengue virus, and the opposite will obtain AV-1 4 days after being challenged with the dengue virus. Every group can be additional subdivided to obtain 100 mg, 300 mg, or 900 mg of AV-1, delivered in a 60-minute intravenous infusion. For every of the three dosage ranges, 12 members will obtain the investigational monoclonal antibody, and two will obtain a placebo.

Earlier than or after AV-1 dosing, every volunteer will obtain an injection of attenuated (weakened) dengue virus. In earlier research utilizing this problem virus, most volunteers developed a rash, and a few had different gentle dengue signs, equivalent to joint and muscle ache or headache. Not one of the volunteers developed dengue fever or extreme dengue. 

Volunteers will take part in common follow-up visits with research employees for at the very least 155 days to rigorously monitor the results of the investigational monoclonal antibody. Via bodily exams, diary playing cards and blood samples, researchers will doc how the volunteers’ immune methods reply to the dengue virus problem, how shortly the virus vanishes from their bloodstream and any signs they might expertise. The researchers will use this info to find out how AV-1 impacts the volunteers’ potential to recuperate from dengue in comparison with placebo and to find out the dosages at which AV-1 could also be efficient.

If AV-1 exhibits promising outcomes on this scientific trial, researchers could pursue additional scientific evaluations of its security and efficacy towards dengue virus. For extra details about the research, go to ClinicalTrials.gov and search the identifier NCT06799741.