Currently, there is no FDA-approved vaccine for malaria.
In October 2015, Center for Infectious Disease Research formed an additional collaboration with Fred Hutchison Cancer Research Center (FHCRC) to join forces on malaria research by jointly implementing the Seattle Malaria Clinical Trials Center (Seattle MCTC) for the purpose of conducting malaria Clinical Trials at the Human Challenge Center. This joint partnership shares a common goal to help expand the global capacity for evaluating new interventions against the deadly malaria parasite.
In addition to its well-established malaria research program, the Center for Infectious Disease Research already has another key component of the HCC in place: the Center for Mosquito Production and Malaria Infection Research (CeMPMIR), under the direction of Dr. Stefan Kappe, PhD, Director of Translational Sciences, which includes an insectary that produces malaria infected mosquitoes under current Good Manufacturing Practice (cGMP) regulations, used in the human challenge trials.
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 called the Controlled Human Malaria Infection (CHMI) Model. 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 an experimental malaria vaccine candidate are deliberately “challenged” with malaria through the bite of malaria-infected mosquitoes to evaluate whether or not the experimental 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 an experimental vaccine forward for testing on a much larger scale and/or in malaria endemic regions of the world.The existing frontline malaria control interventions are not only expensive but also become ineffective owing to the emergence of insecticide and drug resistance, the hope is that one day the development of an effective vaccine will prevent people from getting malaria and to limit malaria disease and deaths around the world.
Studies using controlled human malaria infection (CHMI) have become established as a vital tool to assess the efficacy of malaria vaccine and drug candidates. The deliberate infections of microorganisms in human participants, known as challenge studies, have supported our understanding of the pathogenesis, immune response, treatment and prevention of many microbial diseases. Plasmodium falciparum malaria sporozoites (the infectious form of the parasite) are a particularly valuable target as they have a moderately short and predictable asymptomatic period, a well-established diagnostic test, and no long-term sequelae following treatment.