MALARIA CLINICAL TRIALS
Controlled Human Malaria Infection (CHMI) is a clinical trial model whereby healthy human volunteers are challenged via the bites of Plasmodium-infected mosquitoes or by needle-based delivery of purified Plasmodium sporozoites to assess the efficacy of candidate drugs and vaccines. In the CHMI model, volunteers usually receive either five infected bites in the insectary at Seattle Children's (formerly the Center for Infectious Disease Research) or intravenous injection cryopreserved, wild-type P. falciparum sporozoites. The five mosquito bite and intravenously injected dosages consistently infect 100% of immunologically-naïve subjects.
Following CHMI, RBC-stage parasites are liberated from the liver ~6 days post-challenge and most immunologically-naïve volunteers (e.g., infectivity controls) develop thick blood smear-positive infections ~10-12 days post-CHMI. These infections can usually be detected 2-5 days earlier using the 18S rRNA-based RT-PCR methods developed in our laboratory. Partially-protected subjects may take longer to demonstrate parasites in the blood and completely protected persons will show no parasites in the blood whatsoever. Throughout this time period participants are followed closely to monitor their health and well-being. When a person, reaches a protocol-defined treatment threshold, they receive treatment with an FDA-approved drug and the parasites are subsequently completely cleared from their bodies.
The Seattle Malaria Clinical Trials Center (MCTC) is an inter-institutional project involving the Fred Hutchinson Cancer Research Center, the University of Washington, Seattle Children's Hospital (formerly the Center for Infectious Disease Research), and other Seattle area partners. Dr. Murphy helps to lead the Seattle MCTC in collaboration with MCTC Director Dr. James Kublin. The MCTC works with trial sponsors and regulatory agencies to manage and perform all of the activities required to conduct these studies. For most studies, the Murphy Laboratory performs Plasmodium 18S rRNA RT-PCR to provide same-day quantitative diagnosis of infection. In addition, the CLIA-certified UW Dept. of Laboratory Medicine provides safely laboratory testing in support of the trials.
If you are interested in participating in a trial as a volunteer subject, please visit the Seattle MCTC website.
Following CHMI, RBC-stage parasites are liberated from the liver ~6 days post-challenge and most immunologically-naïve volunteers (e.g., infectivity controls) develop thick blood smear-positive infections ~10-12 days post-CHMI. These infections can usually be detected 2-5 days earlier using the 18S rRNA-based RT-PCR methods developed in our laboratory. Partially-protected subjects may take longer to demonstrate parasites in the blood and completely protected persons will show no parasites in the blood whatsoever. Throughout this time period participants are followed closely to monitor their health and well-being. When a person, reaches a protocol-defined treatment threshold, they receive treatment with an FDA-approved drug and the parasites are subsequently completely cleared from their bodies.
The Seattle Malaria Clinical Trials Center (MCTC) is an inter-institutional project involving the Fred Hutchinson Cancer Research Center, the University of Washington, Seattle Children's Hospital (formerly the Center for Infectious Disease Research), and other Seattle area partners. Dr. Murphy helps to lead the Seattle MCTC in collaboration with MCTC Director Dr. James Kublin. The MCTC works with trial sponsors and regulatory agencies to manage and perform all of the activities required to conduct these studies. For most studies, the Murphy Laboratory performs Plasmodium 18S rRNA RT-PCR to provide same-day quantitative diagnosis of infection. In addition, the CLIA-certified UW Dept. of Laboratory Medicine provides safely laboratory testing in support of the trials.
If you are interested in participating in a trial as a volunteer subject, please visit the Seattle MCTC website.
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