The Seattle Malaria Clinical Trials research aims to reduce the burden of malaria worldwide. We are testing drugs for both malaria treatment and prevention. We need healthy people to volunteer for our studies.
If you have questions about malaria or participating in our studies, we have compiled a list of the most frequently asked questions from our study participants, below.
General Malaria Questions
Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito that feeds on humans. People who get malaria are typically very sick with high fevers, shaking chills, and flu‐like illness. Five kinds of malaria parasites can infect humans: Plasmodium falciparum, P. vivax, P. ovale, P. knowlesi, and P. malariae. Infection with P. falciparum, if not promptly treated, can lead to death. Although malaria can be deadly, illness and death from malaria can usually be prevented and it is easily treated.
Usually, people get malaria by being bitten by an infective female Anopheles mosquito. Only Anopheles mosquitoes can transmit malaria, and they must have been infected through a previous blood meal taken from an infected person. When a mosquito bites an infected person, a small amount of blood is taken in, containing microscopic malaria parasites. About 1 week later, when the mosquito takes its next blood meal, these parasites mix with the mosquito's saliva and are injected into the person being bitten.
Because the malaria parasite is found in red blood cells of an infected person, malaria can also be transmitted through blood transfusion, organ transplant, or the shared use of needles or syringes contaminated with blood. Malaria may also be transmitted from a mother to her unborn infant before or during delivery (congenital malaria).
No. Malaria is not spread from person to person like a cold or the flu, and it cannot be sexually transmitted. You cannot get malaria from casual contact with malaria‐infected people, such as sitting next to someone who has malaria.
Anyone can get malaria. Most cases occur in people who live in countries with mosquito infestation. People from countries with no malaria can become infected when they travel to countries with malaria or through a blood transfusion (although this is very rare). Also, an infected mother can transmit malaria to her infant before or during delivery.
Plasmodium falciparum causes severe and life‐threatening malaria; this parasite is very common in many countries in Africa south of the Sahara desert. People who are heavily exposed to the bites of mosquitoes infected with P. falciparum are most at risk of dying from malaria. People who have little or no immunity to malaria, such as young children and pregnant women or travelers coming from areas with no malaria, are more likely to become very sick and die. Poor people living in rural areas who lack knowledge, money or access to health care are at greater risk for this disease. As a result of all these factors, an estimated 90 percent of deaths due to malaria occur in Africa south of the Sahara (sub‐Saharan Africa); most of these deaths occur in children under 5 years of age. Participants in our trials are followed very carefully once they are enrolled into our studies for all of these reasons.
No, anyone who goes to a malaria‐risk country should take precautions against contracting malaria. Usually, people who live in malaria‐endemic areas have some immunity to malaria. However, without frequent exposure to malaria parasites, your immune system loses its ability to fight malaria. You are as much at risk as a nonimmune person. Please consult with your health care provider or a travel clinic about precautions to take against malaria (preventive drugs and protection against mosquito bites) and against other diseases.
Symptoms of malaria include fever and flu‐like illness, including shaking chills, headache, muscle aches and tiredness. Nausea, vomiting and diarrhea may also occur. Most participants in our studies do not feel sick.
Malaria may cause anemia and jaundice (yellow coloring of the skin and eyes) because of the loss of red blood cells. Infection with one type of malaria, Plasmodium falciparum, if not promptly treated, may cause kidney failure, seizures, mental confusion, coma and death.
For most people, symptoms begin 10 days to 4 weeks after infection, although a person may feel ill as early as 7 days or as late as 1 year later. Two kinds of malaria, P. vivax and P. ovale, can occur again (relapsing malaria). In P. vivax and P. ovale infections, some parasites can remain dormant in the liver for several months up to about 4 years after a person is bitten by an infected mosquito. When these parasites come out of hibernation and begin invading red blood cells (relapse), the person will become sick.
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 for lack of treatment. Ninety percent of malaria deaths in Africa are among children under the age of 5 years.
Over 1,300 American travelers become ill and sometimes die from malaria while abroad or when they get home after traveling.
To learn more about malaria, please visit the Centers for Disease Control and Prevention or World Health Organization.
Screening Questions
No. We compensate participants for time and travel.
Each study is unique in its design and participation requirements. Compensation varies, depending on the number of study visits required. 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.
The amount of time needed for a screening visit varies, but in general, they take from 1 to 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 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 questions, including any about the consent form or other information you may have heard about our studies.
If you decide to agree 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.
Each study requires different tests, 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 advance our knowledge of malaria and the treatment of the disease. You will also have a physical exam, 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 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 in 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 can cause relapse 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 the Fred Hutch Cancer Center 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.