The Malaria Clinical Trials Center (MCTC) will accelerate testing of new investigational drugs and vaccines that can relieve the global burden of malaria, a disease that kills over one million people each year, most of them young children in Africa.

Testing Malaria Vaccines

After a malaria vaccine candidate has been tested for safety in a small number of healthy adult volunteers, some candidates (typically those targeting the early stage of malaria infection) may undergo a challenge phase of testing.   This well established model has been the mainstay of malaria vaccine and drug testing at other sites worldwide for decades.  Under this model, volunteers vaccinated with a malaria vaccine candidate are deliberately “challenged” with malaria through the bite of malaria-infected mosquitoes to assess whether or not the candidate vaccine can prevent or delay malaria infection. This human challenge phase of malaria vaccine development can provide researchers with valuable data to decide whether or not to move a vaccine candidate forward for testing on a much larger scale and/or in malaria endemic regions of the world.

In March 2008, Seattle BioMed and PATH Malaria Vaccine (MVI) announced a collaboration to establish MCTC and the malaria challenge model at Seattle BioMed.  The clinical research center is devoted to testing the safety and efficacy of malaria vaccine candidates in humans. This is one of only four facilities of its kind worldwide and will help expand the global capacity for evaluating new interventions against the deadly malaria parasite.

In addition to its well-established malaria research program, Seattle BioMed already has another key component of the Malaria Clinical Trials Center in place: the Center for Mosquito Production and Malaria Infection Research (CeMPMIR), which includes an insectary that produces mosquitoes needed for the human challenge trials.

Safety is Top Priority

Safety is of utmost importance in the design of our facilities and the conduct of MCTC clinical trials.   The MCTC provides the highest level of care to ensure the safety of volunteers. 

We have worked closely with our colleagues at Walter Reed Army Institute of Research (WRAIR) in establishing the MCTC at Seattle BioMed 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 2 decades.  WRAIR scientists have shared their knowledge with Seattle BioMed scientists and have provided 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. 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 antimalarial 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. While not officially approved by the U.S. Food and Drug Administration (FDA), all studies of investigational drug and biologics must also be reviewed by the FDA for safety before they can be initiated at a center such as ours.

Volunteering for a Clinical Trial

Our trials will start in early 2010, and the MCTC is now actively recruiting volunteers to participate in trials. The number of participants required for each trial will likely vary. 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 for time and transportation is offered to volunteers over the course of participating in a clinical trial. 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.

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.  You can join Seattle BioMed and the MCTC in making a critical difference in global health.  Donating your time by volunteering for a clinical research study is the most valuable contribution to our work. To become the ultimate donor, or for more information on MCTC clinical trials, please click on the “Volunteer” link and enter your contact information and our clinical trials team will contact you. You can also receive e-newsletter updates on the MCTC and malaria research at Seattle BioMed by subscribing to our mailing list.