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NIH: Phase I Trials Of A Dengue Vaccine

 

 

 

# 4797

 

 

Dengue Fever has received a fair amount of coverage here in this blog, and has become a major component of Crofsblog over the past few years. 

 

Mainstream media coverage of this disease has grown in recent months as well, in the wake of the emergence of a handful of Dengue cases in Key West, Florida.

 

The global burden of Dengue is immense, with 2.5 billion people – two fifths of the world's population – at risk of infection.

 

The World Health Organization  estimates there may be as many as 50 million dengue infections each year.

 

Currently, there is no specific treatment, and no vaccine available.   But that may be changing.

 

The NIH has announced the start of Phase I human clinical trials of a tetravalent Dengue vaccine developed by researchers at NIAID, and undergoing study at the Johns Hopkins Bloomberg School of Public Health.

 

Two other vaccine candidates are also under study.  Even if these trials prove successful, a commercially available Dengue vaccine is still a number of years away.

 

Excepts from the NIH press release are below.  Follow the link to read the entire report.

 

 

FOR IMMEDIATE RELEASE
Monday, August 9, 2010

Human Clinical Trial of NIH-developed Dengue Vaccine Begins

After more than a decade of development at the National Institutes of Health, a vaccine to prevent infection by the mosquito-borne dengue virus has begun human clinical testing. The vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) and is undergoing clinical study at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

 

<BIG SNIP>

 

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. 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.

 

For more information, visit NIAID’s Dengue Fever Web portal.

 

 

For some additional blogs on Dengue in Florida, and the Caribbean, you might wish to visit:

 

Healthmap.org: Charting Dengue’s Progress
Puerto Rico Dengue Update
Making Themselves At Home
ASTMH: Dengue and Insect-Borne EIDs In The US
Dengue Reports From The Caribbean

Related Post:

Dengue
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