About the Center

The Malaria Clinical Trials Center (MCTC), set to open at SBRI in 2009, will accelerate testing of new investigational drugs and vaccines that can relieve the burden of malaria, a disease that kills over one million people each year, most of them young children in Africa.

Testing Malaria Vaccines
In March 2008, SBRI and PATH Malaria Vaccine (MVI) announced a collaboration to establish a key component of the MCTC: the Human Challenge Center, devoted to testing the safety and efficacy of malaria vaccine candidates in humans. This will be one of only four facilities of its kind worldwide and will help meet the growing demand to test new interventions against the deadly malaria parasite.

The Human Challenge Center is the critical foundation of the MCTC. In addition to its well-established malaria research program, SBRI 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.

How the Center Will Work
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 likely 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 Top Priority
Safety is of utmost importance in the design of the MCTC site 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 safely throughout the trial, and will be treated with antimalarial medication at the first sign of malaria infection in the blood.  We’ll be working very closely with our colleagues at Walter Reed Army Institute of Research (WRAIR) to establish this center as they have an outstanding safety record and relevant knowledge base. WRAIR scientists will share their knowledge of how to conduct trials with SBRI scientists, as well as provide the mosquitoes and malaria parasites that are needed.

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 welfares of human subjects. While not officially approved by the FDA, all investigational drug and biologics studies must also be reviewed by the FDA for safety before they can be initiated at a center such as ours.

What We Can Learn
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.

For More Information
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 send your contact information to malariatrial@sbri.org, using "please add me to your malaria distribution list" in the subject line.

If you are interested in volunteering for a malaria clinical trial, please check our web site periodically for updates, as well as anticipated start dates of upcoming malaria clinical trials.

This page was updated August 2008

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