Seattle Malaria Clinical Trials Center (Seattle MCTC)
The Seattle Malaria Clinical Trials (Seattle MCTC) is a translational research center established by Fred Hutch and the Center for Infectious Disease Research (CIDR) to test experimental malaria vaccines and drugs in human clinical trials. The Seattle MCTC conducts malaria clinical research studies focused on preventing and treating malaria. We hope to one day develop vaccines that may prevent people from getting malaria and to limit malaria disease and deaths around the world.
Currently, there is no FDA-approved vaccine for malaria. There are FDA-approved drugs to treat and prevent malaria, but malaria is developing resistance to some of the drugs. At the Seattle MCTC, we also study new drugs or drug combinations for treating or preventing malaria.
Safety is of utmost importance in the design of our facilities and the conduct of Seattle MCTC clinical trials. The Seattle MCTC provides the highest level of care to ensure the safety of volunteers.
We worked closely with our colleagues at Walter Reed Army Institute of Research (WRAIR) in establishing the Seattle MCTC to harness their significant expertise in conducting these types of studies. WRAIR is home to the only other U.S. facility conducting malaria challenge trials and they have an outstanding safety record over the last two decades. WRAIR scientists have shared their knowledge with us and have provided the starting materials to establish the mosquitoes and malaria parasites used in our trials.
The laboratory-raised strains of malaria used in these trials are well understood by our scientists and very responsive to common malaria treatment. These malaria parasites are tested to ensure that they can be killed by the standard FDA-approved medications used to treat malaria infection. They have been used in malaria clinical trials of this kind many times without causing severe illness in volunteers. Volunteers are closely monitored to ensure safety throughout the trial and are treated with anti-malarial medication at the first sign of malaria infection in the blood.
All malaria clinical trial proposals are reviewed and approved by an independent Institutional Review Board (IRB), whose primary purpose is to assure the protection of the rights, safety and welfare of human subjects. All studies of investigational drug and biologics (vaccines) must also be reviewed by the U.S. Food and Drug Administration (FDA) for safety before they can be initiated at a center such as ours.