Seattle Biomedical Research Institute (SBRI) announced plans for a program where volunteers will be exposed to the deadliest form of malaria, which kills at least a million people a year. Most victims are African children. But scientists were quick to point out that participating in the clinical trials won't be a life-threatening experience.
While many volunteers will contract malaria, the cloned strain used in the experiments can be quickly cured, and does not cause a recurring form of the disease.
Lt. Col. James F. Cummings, participated in malaria trials at Walter Reed Army Institute of Research in Maryland. "I felt like I had the flu — chills and shakes for the first few hours," Cummings said. He was improving within eight hours of treatment. Symptoms vary. One study found the average volunteer felt bad for about three days.
"It's really important for people to understand how well-controlled this process is," said Dr. Patrick Duffy, head of SBRI's malaria research programs. "The disease follows a predictable course, and it's treated very early — as soon as parasites show up in the blood."
It's highly unusual for medical researchers to intentionally expose people to a disease — particularly one as serious as malaria. The standard approach is to recruit a large group, give half a drug, half a placebo — then wait to see who gets sick.
The trials are time-consuming and will require several nights under medical supervision in a hotel. Volunteers will be compensated, probably in line with the $2,000 to $4,000 paid at Walter Reed. The initial trials will begin within 18 months, Duffy said.
A private lab in Seattle's South Lake Union district, SBRI has become a top malaria research center, largely because of funding from the Bill & Melinda Gates Foundation. The world's richest philanthropy has devoted more than $1 billion to malaria, including $350 million for development of a vaccine.
With several promising vaccines and drugs in the pipeline — and Walter Reed's facility maxed out — it was important to establish another center for human trials.
SBRI was picked because the lab already has a high-security insectary, where researchers raise malaria-infected mosquitoes for research. Contained within three nested rooms, the mosquito lab is equipped with double doors and an air-pressure system designed to suck any escapees back inside.
SBRI scientists are working on a vaccine that uses genetic engineering to render malaria parasites harmless. They also will analyze blood from the human volunteers to learn more about the body's immune response to the disease.
Eliminated long ago in wealthy nations, malaria remains one of the top killers in the developing world. The parasite that causes the disease has evolved resistance to many drugs, contributing to a resurgence.
The volunteers will be closely monitored, checking into a hotel around five or six days after their mosquito bites. Medical staff from the University of Washington will take blood samples every morning and night. At the first sign of parasites in the blood, volunteers will begin taking the anti-malaria drug chloroquine, which completely eliminates the disease. (info from the Seattle Times)
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