Health Technologies

Clinical trial will evaluate new dengue therapeutic

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The Phase 2 clinical trial will enroll at least 84 healthy adult volunteers at two sites: the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the University of Vermont Vaccine Testing Center in Burlington.

Following an initial screening and physical examination, volunteers will be randomly assigned to one of two groups.

One group will receive AV-1 one day prior to being challenged with a mild strain of dengue virus, and the other will receive AV-1 four days after being challenged with the dengue virus.

Each group will be further subdivided to receive 100 mg, 300 mg, or 900 mg of AV-1, delivered in a 60-minute intravenous infusion.

For each of the three dosage levels, 12 participants will receive the investigational monoclonal antibody, and two will receive a placebo.

Before or after AV-1 dosing, each volunteer will receive an injection of attenuated (weakened) dengue virus.

In earlier studies using this challenge virus, 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 dengue fever 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 investigational monoclonal antibody.

Through physical exams, diary cards and blood samples, researchers will document how the volunteers’ immune systems respond to the dengue virus challenge, how quickly the virus vanishes from their bloodstream and any symptoms they may experience.

The researchers will use this information to determine how AV-1 affects the volunteers’ ability to recover from dengue compared to placebo and to determine the dosages at which AV-1 may be effective.

If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against dengue virus.

Image: NIAID

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