Malaria Vaccine Study (GAP3KO) Control Group

Adults age 18 to 50 are needed for a malaria vaccine study.

We are looking for healthy adults age 18 to 50 to help test an investigational vaccine for malaria by participating in a control group. People in the control group will receive a malaria “challenge” and not the investigational vaccine. You do not need to be a Kaiser Permanente member to be part of this research, which is called the GAP3KO Malaria Vaccine Study.

Lisa Jackson, MD, MPH, senior investigator at Kaiser Permanente Washington Health Research Institute, is the lead researcher for the study. Our funding comes from the U.S. National Institutes of Health.

Why is this research important?

Malaria is a significant global health problem. It infects 200 million people and causes about 438,000 deaths worldwide each year. Most cases and deaths are in children less than 5 years old in low income countries. Malaria is caused by a parasite, which is transmitted by mosquito bites. Efforts to develop an effective malaria vaccine have been happening for many years, but there is currently no licensed vaccine available in the United States.

The vaccine that is farthest along in development globally is the RTS,S vaccine, also known as Mosquirix™. That vaccine contains parts of the malaria parasite. It was first tested in adults in malaria-free regions. Adults who were given the vaccine were then exposed to malaria to see if the vaccine could prevent infection. Promising results from those trials led to the start of a large study involving 15,000 young children in Africa. The vaccine was modestly effective, reducing malaria cases by about one-third over a four-year period, but the protective effect lessened over time. Mosquirix will be given to children in three African countries under a pilot program starting in 2018. It is considered to be an important advance, but more effective vaccines are still needed.

What is the purpose of this study?

This study will look at how well a newer investigational vaccine prevents malaria infection in adults. The vaccine is made up of malaria parasites that have been genetically modified so that they cannot grow in the bloodstream and cause infection. The parasites are fed to mosquitoes raised in the laboratory, and the vaccine is given by the bite of those infected mosquitoes.

What is the malaria challenge?

A malaria challenge is a standard part of malaria vaccine studies that is done to see whether the vaccine provides protection against the illness. There is no blood test that can tell us if the vaccine works to create an immune response that prevents malaria. The malaria challenge is the only way to find this out. Without the malaria challenge, vaccines that show promise can’t go on to larger research studies in areas where malaria infection occurs. Control subjects are also enrolled in the challenge, to make sure that the challenge procedures really do cause malaria infection in people who have not received the study vaccine. This verifies the adequacy of the challenge.

Who can be in the study?

This study will enroll healthy adults age 18 to 50. People who have medical conditions that affect the immune system or are taking medications that affect the immune system may not be in the study. There are other conditions that may make you ineligible for this study.

What will happen if you enroll in the study?

  • Control subjects will have up to 20 scheduled study visits and 1 phone visit over an 8-month period. 
  • This study will have two malaria challenges; one in August 2018, and one in February 2019.
  • Control subjects will participate in only one challenge. The challenge involves being bitten by five mosquitoes infected with fully infectious malaria parasites.
    • Control subjects are expected to develop malaria infection after the challenge.
  • After the challenge, we will use a blood test called “PCR” to detect very low levels of malaria parasites in the blood. This testing will happen frequently, often daily, during the time that infection could occur.
  • If/when malaria infection occurs, treatment will be given with an oral medication (Malarone) that is effective against the malaria parasites used in the study.
  • The study visits will primarily be held in Kaiser Permanente Washington’s research clinic in the Metropolitan Park East building, near I-5 in downtown Seattle. The challenge visit will be held at the Seattle Children's Research Institute (formerly known as the Center for Infectious Disease Research) facility in the South Lake Union area. Parking or bus fare will be provided.
  • During part of the study, visits will happen every day, including some weekends. Most visits will need to occur early in the morning, around 7 or 8 a.m.
  • To thank you for your help, you will receive $200 for the challenge visit and $50 for each of the other study visits you complete. The total amount received will be up to $1150.

Let us know if you might be interested

If you think you might want to be part of this study and would like more information, please email us at KPWA.vaccine@kp.org. Include your full name, phone number, and the best time to call, and we’ll get back to you soon.