Safety is Top Priority
Q: What is the Malaria Clinical Trials Center?
A: The Malaria Human Challenge Center (HCC) is facility established by the Center for Infectious Disease Research to test experimental malaria vaccines and drugs in human clinical trials. This is only one of four the centers in the world capable of testing new experimental malaria vaccines or drugs in humans by the Controlled Human Malaria Challenge (CHMI) model, whereby participants are “challenged” with malaria under controlled conditions receiving the bites of a malaria infected mosquitos. This challenge will test how well an experimental vaccine or drug works against malaria.
Q: I'm interested in being a participant in a research study, how do I find out more?
Q: Are there other centers that do this sort of testing?
A: Yes. Other centers in England, the Netherlands and at Walter Reed Army Institute of Research (WRAIR) in Bethesda, Maryland, have been conducting human challenge trials for decades, but there is mutual recognition that expansion of the global capacity for conducting these types of trials is urgently required in order to bring new solutions to the world.
Q: What expertise is the Center for Infectious Disease Research using to run the facility?
A: To establish the HCC and the human malaria challenge model at the Center for Infectious Disease Research we worked very closely with our colleagues at WRAIR. WRAIR has been conducting challenge trials for decades with an outstanding safety record and expert knowledge base. WRAIR scientists have shared their expertise and provided the initial starting materials to produce the mosquitoes and malaria parasites for use in our trials at the HCC. Currently, the Center for Mosquito Production and Malaria Infection Research (CeMPMIR), under the direction of Dr. Stefan Kappe, PhD, produces malaria infected mosquitoes used for the human challenge trials under current Good Manufacturing Practice (cGMP) regulations.
The clinical trials utilize a joint collaborative approach whereby the HCC provides infected mosquitoes and facilitates the administration of the challenge product. Many clinical trials are led by Principal Investigator Dr. James G. Kublin, MD, MPH, who has extensive expertise in infectious disease, including malaria and HIV. The rest of our team includes: Dr. Sean C. Murphy, MD, PhD is the HCC Medical Director with additional expertise in detection of malaria using qRT-PCR; Dr. Stefan Kappe, Director of Translational Science is focused on understanding the complex biology of the malaria parasite and the immune responses to infection; he has also developed a Genetically Attenuated Parasite (GAP) vaccine candidate that recently completed safety trials. Finally, the HCC manager Emma Fritzen has extended knowledge in cGMPs as functional area lead of the clinical facilities and day-to-day operational expertise in the CeMPMIR insectary and challenge center. The HCC and Seattle MCTC partner with local clinical research sites to conduct trials. These sites include Fred Hutchinson Cancer Research Center’s Vaccine Trial Unit, MVI and the University of Washington’s Virology Research Clinic.
Q: Is it safe to participate in malaria clinical trials?
A: The model of “challenging” humans in malaria vaccine trials is a well-established method that has been the mainstay of malaria vaccine and drug evaluation for decades. The type of malaria that volunteers are challenged with is a laboratory-raised strain under strictly controlled conditions (GMP) that is easy to diagnose and treat because it is very responsive to conventional malaria drugs. Other centers have conducted trials of this nature for decades with an extensive safety record. Participants challenged with malaria may develop flu-like symptoms with infection, but will be treated at the first sign of infection in the blood.
Safety is of utmost importance in the design of our facilities and the conduct of malaria clinical trials. The HCC 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 challenge center 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 the Center for Infectious Disease Research scientists 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 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.