Trials Malaria Research with a transmission blocking malaria vaccine

We are searching for healthy study participants in the age of 18 - 55 years to participate in a malaria research study with a transmission blocking malaria vaccine.

Malaria

Malaria is the most common tropical infectious disease. Despite the available medication, insecticides and mosquito nets, more than 200 million people annually contract the disease, resulting in nearly half a million deaths.

Malaria is caused by a parasite called Plasmodium, which is transmitted from humans to humans via mosquitoes. When a mosquito bites a malaria patient, parasites can be transferred to the mosquito. The parasites continue to develop in the mosquito, ultimately making the mosquito's saliva contagious to other people the next time it stings.

Purpose of the study

R0.6C is a new vaccine that can block the spread of malaria. In this research (called STOP-TRANS study), the active substance R0.6C will be combined with the adjuvant Alhydrogel or with two adjuvants Alhydrogel and Matrix-M to enhance the immune response. The R0.6C vaccination with adjuvants has been tested in the laboratory and also on animals, but never before on humans. The vaccination does not cure or prevent malaria, but it blocks the transmission of parasites from humans to the mosquito and can thus prevent the spread of malaria in the population.

Compensation for participation

You will receive a compensation of € 1305 for participating in this study. You will not be reimbursed for travel expenses. The full amount will only be paid when volunteers accomplish all study visits. The compensation for participating has to be reported to the Dutch Tax and Customs Authority as income.

Register

Are you interested in participating or would you like to receive more information? Register here

Participating in this trial

The duration of this study is about about 9 months in total. There are 29 appointments in total, 4 appointments take place at Radboudumc, the other appointments can take place in Radboudumc or in the Vaccination Center in Wageningen, depending on your preference, When you register via the registration button on this website, you will receive a patient information letter within a few working days.

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Participating in this trial

Are you participating in the study? Then it takes about 9 months in total. There are 29 appointments in total, 4 appointments take place at Radboudumc, the other appointments can take place in Radboudumc or in the Vaccination Center in Wageningen, depending on your preference.

If you register via the registration button on this website, you will receive an information letter within a few working days. In this letter you will find all the information of this study and you will read about what taking part in this study means.We will also invite you to a voluntary (digital) information session. IIf you subsequently decide to participate in this coronavirus vaccine research, you will go through the following steps:

Step 1: are you eligible to take part?

If you are interested in participating, you will be invited for a screening visit. During this visit there will be the chance to ask any remaining questions about the trail. After that, the consent form will be signed by you and the researcher. Before you can participate in this research, we first want to know if you are suitable to participate. That is why the researcher will conduct a number of examinations.

Step 2: the vaccination

You will receive a R0.6C vaccination in your upper arm a total of 4 times. The vaccination contains at least the active ingredient R0.6C and the adjuvant Alhydrogel, in half of the volunteers the vaccination also contains a second adjuvant Matrix-M. Four weeks after the 1st vaccination you will receive the 2nd vaccination, after another 4 weeks the 3rd vaccination will follow. Then there is 16 weeks between the 3rd and the 4th vaccination. The 4 vaccinations you will receive have the same dose, but this dose differs per study group. Each vaccination involves a number of follow-up visits (see step 3). You will be asked to report all symptoms you experience from the first vaccination until the last follow up visit in a study diary.

Step 3: study and measurements

The research requires that you come to the research center a total of 29 times in 9 months. If you are eligible for this trial, we ask that you come by again just before the trial starts for the "inclusion" visit. During this visit, we will repeat a number of examinations of the screening to verify that you are still eligible to participate in this study. We also take blood again and perform a new pregnancy test for women.

On the days that the R0.6C vaccine is administered, you have to stay in hospital for half a day. After each vaccination you will come to the research center up to 7 times for a short follow-up visit.

What are the pros and cons if you take part in the study?

Participating in the study can have advantages and disadvantages, those are listed below. Think about this carefully and discuss it with others.

There are no personal benefits from participating in this study. But with your participation you  will contribute to the development of a vaccination that blocks the transmissibility of malaria.

Participation in the study may have the following drawbacks:

  • You may experience the side effects or adverse effects of the vaccination.
  • You may be bothered by the measurements during the examination. For example: a blood sample can be painful. Or it could result in a bruise.
  • Participating in the study will cost you extra time.
  • You have to adhere to the agreements associated with the research.

It is possible that something is accidentally discovered during the investigation that is not directly relevant to the research, but is important for your health or that of your family members. In this case, you will be informed by the investigator, but your own GP or specialist will discuss with you what needs to be done next. The costs will be covered by your own health insurance.

Compensation

This research study is divided into 8 groups. The compensation you receive for participation is 1305 euros, regardless of the group in which you participate. This allowance is declared to the Tax and Customs Administration as income.


Who can participate?

We are looking for volunteers that

  • are healthy
  • are 18 - 55 years old
  • are residing in Nijmegen or Wageningen area
  • have no history of malaria

The vaccine

R0.6C is a vaccination aiming to block the spread of malaria. In this study we look at the safety and possible side effects of the R0.6C vaccine and whether the R0.6C vaccine induces an immune response in healthy subjects. We will test R0.6C at two different strengths. We will also test R0.6C with different adjuvants, with Alhydrogel alone or with two adjuvants: Alhydrogel and Matrix-MThe results of this research are important for further development of R0.6C vaccine and to stop the spread of malaria. The vaccination does not cure or prevent malaria, but it blocks the transmission of parasites from humans to the mosquito and can thus prevent the spread of malaria in the population.

Study timelines

For this research we will make 8 groups.

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Study timelines

For this research we will make 8 groups:

Group

Number of study subjects

Dosis R0.6C vaccin

Matrix-M adjuvant

Start date

1A

3

30 micrograms

No

May 17, 2021 -> already started

or

July 12, 2021

1B

3

30 micrograms

Yes

May 17, 2021 -> already started

or

July 12, 2021

2A

5

30 micrograms

No

September 13, 2021

2B

5

30 micrograms

Yes

September 13, 2021

3A

3

100 micrograms

No

September 27, 2021

3B

3

100 micrograms

Yes

September 27, 2021

4A

5

100 micrograms

No

October 12, 2021

4B

5

100 micrograms

Yes

October 12, 2021

Groups 1, 2, 3 and 4 will start with the vaccinations at different times. You can choose which group you want to join. Within each group, a lottery will determine which subgroup (A or B) you will be in, a subgroup with or without the adjuvant Matrix-M.


Malaria

Malaria is the most common tropical infectious disease.

read more

Malaria

Malaria is the most common tropical infectious disease. Despite the available medication, insecticides and mosquito nets, more than 200 million people annually contract the disease, resulting in nearly half a million deaths.

Malaria is caused by a parasite called Plasmodium, which is transmitted from humans to humans via mosquitoes. When a mosquito bites a malaria patient, parasites can be transferred to the mosquito. The parasites continue to develop in the mosquito, ultimately making the mosquito's saliva contagious to other people the next time it stings.

Development of malaria vaccines

Thanks to global attention to the spread of malaria, the number of malaria cases has dropped by nearly 50% over the past ten years. However, malaria continues to be responsible for a great deal of suffering and death. That is why our research focuses on the development effective malaria vaccine and malaria transmission blocking vaccines.

More information


Contact

drs. Manon Alkema
Clinical researcher

+31 (6) 1539 9580
contact

Contact

drs. Merel Smit MSc
Clinical researcher

+31 6 1539 9580
contact