Seattle Malaria Clinical Trials Center (Seattle MCTC)
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Yes. Malaria is endemic to sub‐Saharan Africa, Central and South America and Southern Asia. Over 300 million people are diagnosed with malaria each year and about 1 million die due to lack of access to treatment. Ninety percent of malaria deaths in Africa are children under the age of 5 years.
It is also of interest that over 1,300 American travelers become ill and sometimes die from malaria while abroad or when they get home.
No. We compensate participants for time and travel.
Each study is unique in its design and intensity. Because of this, there are different amounts of compensation for each study, based on the number of study visits. Generally, a participant is compensated around $25 for a screening visit. If you would like to know more about a specific study’s compensation schedule, we can discuss that during your screening visit.
Screening visit times vary but may take from 1-3 hours. First, a clinical trial staff member will read and discuss the study informed consent form with you. The consent form is a very detailed document that provides all of the information you need to make your decision about participating, including the risks and benefits and the study procedures. You will be given an opportunity to ask any questions you have about the consent form or information you may have heard about our studies.
If you decide to consent to participate in a trial, the clinical trial staff will review your medical history, current health, and medications. A licensed medical professional may perform a physical exam. Your blood may be drawn for laboratory testing to ensure you are an appropriate candidate for the trial. is usually about 2‐3 hours. The bulk of the time is taken by reading and discussing the consent form with the clinical trial staff member. The consent form is a very detailed document that will provide all of the details regarding the study design for the trial you are screening for. You will also be given an opportunity to ask any questions that you have about the consent form or information that you may have about our studies.
Each study requires different testing depending on the investigational product. In general, at screening, you will receive blood testing for baseline measures and safety information. We will also use some of your blood for research purposes, which can further our knowledge of malaria and the treatment of the disease. A physical exam is also performed and the clinical trial staff will ask you about your medical history and current health.
It is possible you will contract malaria by participating in one of our clinical trials. After a malaria drug or 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 are deliberately “challenged” with malaria through the bite of malaria-infected mosquitoes to evaluate whether or not the experimental vaccine or drug can prevent or delay malaria infection. This human challenge phase of malaria vaccine or drug development can provide researchers with valuable data to decide whether or not to move forward for testing on a much larger scale and/or in malaria endemic regions of the world.
If you are diagnosed with malaria during the infection‐phase of the trial, you will be treated with FDA‐approved antimalarial medications. There are also backup anti‐malarial medications that are used if you have a reaction to the initial treatment.
Most participants in our studies do not feel sick.
No. Malaria is transmitted via the bite of a specific species of mosquito that is very rare to this area. You cannot transmit malaria through casual contact, like sitting next to someone who has malaria or through sexual contact. For this reason, you are not required to isolate yourself while infected with malaria.
At the present time, we are not working with the species of parasites that have recurrence in the human body. These species are P. vivax and P. ovale, and they are only in the first stages of research at other sites that are doing malaria clinical trials. We currently only use a laboratory‐created strain of P. falciparum which is mostly found in sub‐Saharan Africa.
The strain of malaria parasite that we are using for our clinical trials was created to be sensitive to the most common, well‐tolerated anti‐malarial therapies. In endemic countries, many of the parasite species that cause malaria have become resistant to many anti‐malaria drugs; however, we only use laboratory‐created specimens to ensure no variability in the parasites with which you would be infected.
The American Red Cross states that you may not donate blood or blood products for 3 years after you have been infected with malaria.
Study participants play a very important role in our research, and the safety and rights of participants are given the highest priority. Our studies meet international standards for ethical research that were created by the Helsinki Declaration of the World Medical Association and Council for International Organizations of Medical Sciences (CIOMS) guidelines.
In addition, our study location works with Fred Hutchinson Cancer Research Institutional Review Board (IRB), sometimes called an Ethics Committee, that reviews all of the details of the study. These groups also make certain that the rights of participants are protected.
It is important for participants to know that any new study product may have both medical and non-medical risks, and there may be additional risks that we do not know about yet.
Although we would like our volunteers to be committed to completing a study, you are free to withdraw from the study at any time.