"This is a time not for despair but for a global commitment to make the most of our scientific knowledge to address the problems of our age." - President Jimmy Carter

The public response to the news that Seattle will become host to a new center to test malaria vaccine candidates – one of only four such centers in the world – has been incredibly strong. Seattle Biomedical Research Institute (SBRI) and the PATH Malaria Vaccine Initiative are collaborating to establish the Malaria Clinical Trials Center (MCTC) in Seattle. The MCTC will allow testing of new investigational vaccines and drugs to combat malaria, a disease that kills over one million people each year, most of them young children in Africa. This represents a unique opportunity to accelerate malaria vaccine research, with the ultimate goal of developing an effective vaccine to save millions of lives.

Trials will likely start in summer 2009, and SBRI will begin actively recruiting volunteers for the trials closer to that time. The number of participants required for each trial will vary, but may ultimately be in the range of a few hundred per year. Likewise, eligibility criteria for each trial may vary, but in general healthy people between the ages of 18-45 may be eligible to participate in this effort.

Compensation offered to volunteers over the course of participating in a clinical trial is for time and transportation. The compensation amount varies based on the design of each study and number of required visits, and must be approved by an independent oversight committee before the study begins. For these reasons, it is not known at this time what the compensation for any particular trial will be.

Safety is of utmost importance in the design of the MCTC at SBRI and in any trials to be conducted there. The malaria parasites used in the trials are well known to malaria researchers, are very responsive to malaria treatment, and have been used in malaria clinical trials of this kind many times without causing severe illness in volunteers. Volunteers will be monitored closely to ensure safety throughout the trial, and will be treated with antimalarial medication at the first sign of malaria infection in the blood.

All malaria clinical trial proposals are submitted for review to an independent Institutional Review Board, whose primary purpose is to assure the protection of the rights and welfare of human subjects. While not officially approved by FDA, all investigational drug and biologic studies must also be reviewed by FDA for safety before they can be initiated at a center such as ours.

This clinical testing phase of malaria vaccine development can provide researchers with valuable information to decide whether or not to move a potential vaccine forward for testing on a much larger scale and/or in malaria endemic regions of the world. The ultimate benefit from participation in malaria vaccine trials is the knowledge that one individual can contribute to the development of a new health intervention with the potential to save millions of lives.

If you would like to receive periodic updates by email on the status of malaria vaccine research at SBRI and the development of the MCTC, please email malariatrial@sbri.org  with your contact information, and use the subject header “please add me to your malaria distribution list.”

If you are interested in volunteering for a malaria clinical trial please check back periodically on our website (www.sbri.org) for updates on the completion of the Malaria Clinical Trials Center, as well as an anticipated start date of upcoming malaria clinical trials.

This page was last updated on March 7, 2008.

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