The researchAbout 500,000 people die annually of malaria. Young children in Africa suffer very high rates of death from malaria. An effective vaccine could protect them. RUMC has conducted malaria vaccine research for more than 15 years.
Purpose of the study
This study will investigate how safe and effective immunization with NF135 malaria sporozoites is against a controlled human malaria infection. The effects of three immunizations with malaria parasites of NF135 origin under prophylaxis will be reviewed in two groups, cohort A and cohort B. The effects will be tested by infecting the study volunteers with malaria after the immunizations.
Study volunteers who do not get malaria will have been protected, while those who do get malaria will not have been protected. There will also be a third group of study volunteers who do not receive immunizations, but will be infected with malaria. This will be the 'control group'. Currently we are looking for participants for Cohort B which starts in January 2020.
Study timelines CPS135 study
This study will investigate how safe and effective immunization with NF135 malaria sporozoites is against a controlled human malaria infection.
Starts January 2020
Research group B158 volunteers will participate in this study. Volunteers will be divided into 2 groups, cohort A and cohort B (research groups), and a third control group. Volunteers from research group B1 will receive three CPS immunizations. There will be 6 weeks between each immunization, followed by a controlled human malaria infection. Volunteers from the control group will not receive immunizations and will only participate in the malaria infections as control groups.
Start January 6, 2020.The study lasts about 16 weeks from study start.
Compensation2300 - 3100 euro
starts September 2020
Research group B258 volunteers will participate in this study. Volunteers will be divided into 2 groups, cohort A and cohort B, and a third control group. Volunteers from cohort A and cohort B will receive three CPS immunizations. Volunteers from the B2 research group (control group) will not receive immunizations and will only participate in the malaria infections as control groups.
Study periodResearch group B2 starts in September 2020.The study lasts about 1 month from study start.
start early January 2020
Research group 3
Twenty healthy volunteers will participate in this study. There are four groups of five volunteers. Each group will receive a different dosage of TB31F because we want to test the safety and possible side effects of TB31F. We also want to study what dosage is necessary to block transmission of malaria parasites. You can choose in which group you want to be. The first group will receive the lowest dose of TB31F; group 2 will receive a slightly higher dose, and so on.
Study periodStart: January 2020.The study lasts 12 weeks from the day of TB31F dosing. There are 11 visits in total. On the day of TB31F administration, you will have to stay at the hospital for the entire day. In the evening, you can go home but you will have to return to the hospital 8 more times for short follow-up visits.
Who can participate?
We are looking for volunteers that
- are healthy
- are 18 - 35 years old
- are residing in Nijmegen
- have no history of malaria
Malaria vaccine developmentThrough controlled human malaria infections in healthy volunteers, researchers can study the immune response to malaria. We use this knowledge to develop new, better malaria vaccines.
We research how the malaria parasite itself can be used as a vaccine by repeatedly infecting healthy volunteers with malaria while they take antimalarials. The antimalarials prevent the volunteers from becoming ill, but the immune system comes into contact with the parasite and learns how to destroy it. If these volunteers are bitten by mosquitoes with malaria again, they will no longer become sick even without the antimalarials.
Together with the Leiden University Medical Center and the American company Sanaria Inc., a weakened malaria parasite has been developed at Radboud university medical center, in which two genes have been removed. This “genetically modified” parasite stops developing early on, which, as expected, results in no symptoms occurring in the human subject, but it is still recognized by the immune system. In 2017, we will test if this parasite can be used as a vaccine.
Testing malaria vaccinesTesting of a potential vaccine must first be done extensively on laboratory animals. At a later stage, the vaccines will be tested on healthy volunteers. After a malaria vaccine is found to be safe in healthy volunteers, it will be tested whether the vaccine is effective in preventing malaria. Sometimes, this research is conducted among a group of volunteers in countries where malaria is very common, like in Africa. However, these types of studies are often difficult to set up and conduct in Africa. In order to advance the development of malaria vaccines, these types of studies can also be performed in countries where malaria does not occur naturally. This involves healthy volunteers receiving the new vaccine and being exposed to malaria under strictly controlled conditions in order to see whether the vaccine can effectively prevent malaria.
The Center for Clinical Malaria Studies (CCMS) of Radboud university medical center in Nijmegen is one of the few places in the world where the malaria vaccine can be tested on healthy volunteers. In the meantime, the CCMS has accumulated over fifteen years of experience in this area.
In the years to come, multiple studies with promising malaria vaccines will be performed at the CCMS.