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Human clinical trial of NIH-developed dengue vaccine begins
Date:8/9/2010

e combinations of the four monovalent vaccines.

In this Phase I trial, study volunteers who have never been exposed to dengue were randomly assigned to receive one of the candidate tetravalent vaccine formulations or a placebo. http://clinicaltrials.gov/ct2/show/NCT01072786?term=dengue&state1=NA%3AUS%3AMD&rank=11. The candidate vaccines are live-attenuated, or created by making the live virus harmless or less virulent.

Evaluation of a second candidate combination vaccine has been initiated at the University of Vermont in Burlington, and trials of the third candidate will begin shortly thereafter at Johns Hopkins. These early clinical trials are designed to test the vaccine's safety and ability to stimulate immune responses in healthy adults ages 18 to 50. After a baseline assessment, participants will receive one dose of the assigned vaccine or placebo. At follow-up study visits over the next six months, the researchers will assess their health and dengue symptoms and collect blood and urine samples for analysis. After determining which tetravalent vaccine is most promising, the researchers will test that candidate in a trial in a new group of volunteers in Brazil, where dengue has become highly prevalent.

The next stage of testing, a Phase II trial, will involve more participants and will test for differences in preliminary signs of effectiveness between people who have been exposed to dengue and those who have not, as well as the need for a booster shot within a few months of the initial vaccination. "If everything goes well after that stage, we hope to start the final phase of human testing in three to four years," says Dr. Durbin.


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Contact: Nalini Padmanabhan
padmanabhannm@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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