Trials Coronavirus vaccine research

COVID-19 is the disease caused by the coronavirus SARS-CoV-2. The disease can cause respiratory symptoms and fever, and in severe cases it leads to breathing problems. The virus is spread via coughing and sneezing. When someone coughs or sneezes, the virus is released into the air in droplets. If other people inhale those droplets, or get them in their mouth, nose or eyes, for example via their hands, they may become infected with the virus. Anyone can become seriously ill from the coronavirus SARS-CoV-2, but some people have a higher risk of severe illness from COVID-19. This ABNCoV2 vaccine is designed to protect people against COVID-19 disease. After the vaccine is administered, the body is supposed to make antibodies against the SARS-CoV-2 virus. The body is then well prepared when it comes into contact with the SARS-CoV-2 virus.

Purpose

The aim of this study is to test the safety and possible side effects of the ABNCoV2 vaccine in healthy subjects and to study if an immune response is generated after ABNCoV2 administration. In this study, different doses of the ABNCoV2 vaccine without adjuvant are compared to the ABNCoV2 vaccine with adjuvant. ABNCoV2 is a vaccine that might protect against the SARS-CoV-2 virus. The ABNCoV2 vaccine is a vaccine that has not been tested in humans before. However, it has been extensively tested in the laboratory, and also on animals.

The results of this research are important to help reduce the virus-spread, to protect vulnerable populations worldwide, to decrease the load on the health care systems and to reduce the economic impact.

The ABNCoV2 vaccine is not part of national COVID-19 vaccination program in the Netherlands.

Compensation

This research study is divided into 7 groups. The compensation you receive for participation is 1000 euros, regardless of the group in which you participate. This allowance is declared to the Tax and Customs Administration as income.

Register (in Dutch)

We organize voluntary (digital) information sessions for this research. Do you want to participate and/or receive more information? Register here. Registration form

Who can participate?

You can participated if you:

  • are healthy
  • are between the age of 18 -55 years old
  • live in (the area of) Nijmegen
  • do not have had the coronavirus
  • are not yet vaccinated with a coronavirus vaccine

The vaccine

This study is an European Union-funded consortium that develops a Virus-Like particle vaccine SARS-CoV-2 vaccine to prevent infection and spread of Covid-19.

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The vaccine

This research study is an European Union-funded consortium that develops a Virus-Like particle vaccine SARS-CoV-2 vaccine to prevent infection and spread of Covid-19.

The technology

For this study capsid virus-like particle (cVLP) technology is used to develop a second generation Covid-19 vaccine. cVLPs are successfully used in several marketed vaccines, e.g. for the prevention of human papilloma virus infection. To the immune system, cVLP vaccines look like a virus but they cannot replicate. This leads to very good immune responses and a good safety profile, even in immunosuppressed individuals. So far, development times for cVLP vaccines were very long because the technology is highly complex. While studying malaria vaccines we developed a novel technology that greatly facilitates production of cVLP vaccines because the cVLP and the vaccine antigen can be produced independently and then “glued” together. This leads to focusing of the antibody response towards the vaccine antigen leading to highly effective immune responses. 

The project

the consortium has developed the cVLP-based Covid-19 vaccine ABNCoV2 and plan to test it in healthy adult volunteers to find the best dose, schedule and formulation of vaccination. The vaccine will be tested with and without the adjuvant MF59. Adjuvants can make immune responses stronger, which is particularly important when very old or immunosuppressed individuals are immunized.

 

The partners and their main roles

  • AdaptVac is a biotechnology company owned by the inventors of the novel cVLP platform technology that spun out from the University of Copenhagen. AdaptVac provides the technology and knowhow relating to cVLPs and is responsible for manufacture of the vaccine.
  • University of Copenhagen leads the consortium. It has a long track record in vaccine development. It was here where the novel VLP technology was originally discovered.
  • University of Tübingen provides project management and is involved in set up of the clinical trial.
  • ExpreS2ion Biotechnologies is a biotechnology company specialized on the production of proteins using insect cells. They are responsible for process development and expression of the vaccine antigen.
  • Wageningen University works on the design of the vaccine antigen and tests different expression systems to select the best candidates.
  • Leiden University Medical Center is responsible for functional assays to measure if the vaccine induces immune responses that prevent infection with SARS-CoV-2.
  • Radboud University Medical Center is responsible for the first-in-human trial of the Covid-19 vaccine candidate ABNCoV2. Here, the vaccine will be formulated and tested in healthy, adult volunteers to identify the optimal dose, schedule and formulation. With this information, ABNCoV2 will enter further clinical development to be available for use in late 2021.

Participating in this trial

The duration of this study is about 7 month. There are 16 appointments in total: 14 of which take place in the hospital and 2 appointments are by telephone. 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 taking part in the study? It will take about 28 weeks (7 months) in total. There are 16 appointments in total, 14 of which take place in the hospital and 2 appointments are by telephone.

There are 42 healthy volunteers participating in this study. The volunteers are divided over 7 groups of 6 volunteers each. Each group will receive a different dose of the vaccine to test the safety and possible side effects of the vaccine, and to find the best dose, schedule and formulation of vaccination.

The ABNCoV2 vaccine formulated with or without MF59 adjuvant is administered in the muscle of the upper arm. Four weeks after the vaccination, all volunteers will receive a second vaccination, a so-called ‘booster’. The second vaccination has the same dose and formulation as the first vaccination. 

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?
First, we want to know if you are eligible to take part. During the screening, the consent form will be signed by you and the researcher. During this screening visit you will also have the opportunity to ask questions. Before you can participate in this trial, we want to check whether you are eligible for participation. Therefore the investigator will invite you for a screening and perform some medical examinations.

Step 2: the vaccination
There are 42 healthy volunteers participating in this study. The volunteers are divided over 7 groups of 6 volunteers each. Each group will receive a different dose of the vaccine to test the safety and possible side effects of the vaccine, and to find the best dose, schedule and formulation of vaccination.

The ABNCoV2 vaccine formulated with or without MF59 adjuvant is administered in the muscle of the upper arm. Four weeks after the vaccination, all volunteers will receive a second vaccination, a so-called ‘booster’. The second vaccination has the same dose and formulation as the first vaccination.

Step 3: study and measurements
For the study, you need to visit the hospital 15 times in 28 weeks (7 months).
 

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

Taking part in the study can have pros and cons. We will list them below. Think about this carefully and talk to other people about it. You yourself do not benefit from taking part in this study. But if you take part you will help in the search for a new vaccine against COVID-19.

Taking part in the study can have these cons:

  • You may experience the side effects or adverse effects of the ABNCoV2 vaccine and/or MF59 adjuvant.
  • There may be some discomfort from the measurements during the study. For example: taking a blood sample can be a little painful. Or you could get a bruise as a result.
  • Taking part in the study will cost you extra time.
  • You need to be hospitalised during half a day.
  • You have to comply with the study agreements.

It is possible that an accidental discovery is made during the study that is not directly related to the research, but does concern your health or that of your family members. If this happens, your own doctor or specialist will discuss with you what needs to happen next. The cost of this will fall under your own insurance policy.

By participating in this study, it is also possible to receive one of the authorized corona vaccines from the national vaccination program. You will receive more information about this during the informal information meetings.

Compensation

This research study is divided into 7 groups. The compensation you receive for participation is 1000 euros, regardless of the group in which you participate. This allowance is declared to the Tax and Customs Administration as income.


Timelines

The volunteers in this study are divided over 7 groups of 6 volunteers each. Every group has a different planning.

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Timelines

The volunteers are divided over 7 groups of 6 volunteers each.  You can indicate your preference with which group you want to participate. The study team makes the final division of the groups. If the group of your choice is full, the clinical investigator of the study will inform you about other groups where there is still room available.

Group

Amount of participants

Dosage coronavirus vaccine ABNCoV2

MF59-adjuvant

Start date

Group 1A

3

6 microgram

No

15 March 2021

Group 1B

3

6 microgram

Yes

22 March 2021

Group 2A

3

12 microgram

No

22 March 2021

Group 2B

3

12 microgram

Yes

29 March 2021

Group 3A

3

25 microgram

No

29 March 2021

Group 3B

3

25 microgram

Yes

6 April 2021

Group 4

6

50 microgram

To be determined*

3 May 2021

Group 5

6

70 microgram

To be determined*

10 May 2021

Group 6

6

Second highest

optimal dosage**

To be determined*

11 June 2021

Group 7

6

Optimal dosage**

To be determined*

11 June 2021

Half of the volunteers in groups 1 to 3 receive the vaccine ABNCoV2 without adjuvant (groups 1A, 2A and 3A) and the other half receives the vaccine ABNCoV2 with adjuvant (groups 1B, 2B and 3B).
* In groups 1 to 3 we will test whether adding the MF59-adjuvant to the vaccine ABNCoV2 improves the effect of the vaccine. If this is the case, groups 4 to 7 will receive the ABNCoV2 vaccine with adjuvant. If the vaccine efficacy does not improve with the adjuvant, then the volunteers in groups 4 to 7 will receive the ABNCoV2 vaccine without adjuvant.


** The results of group 1 to 5 are used to determine the optimal dose of the ABNCoV2 vaccine. The optimal dose and the second highest optimal dose are tested again in group 6 and group 7. Volunteers in group 6 receive the second highest optimal dose and the volunteers in group 7 receive the optimal dose.
For example: if the results of groups 1 to 5 show that 50 microgram is the best dose, then group 6 receives 25 microgram and group 7 receives 50 microgram.


The Dutch COVID-19 vaccination program and this research

The ABNCoV2 vaccine (COVID-19 vaccine) is not part of the national COVID-19 vaccination program in the Netherlands. It is important to know that: 

  • If you participate in this study and you receive a call for an authorized corona vaccine from the vaccination program, you must report this to us immediately. We will then discuss with you when you can get the vaccination, or whether you may need to postpone the vaccination for a few weeks.
  • Regardless of your participation in this study, you can also receive the authorized corona vaccine from the Dutch COVID-19 vaccination program. Depending on where you are in the follow-up period, we may ask you to postpone your vaccination.
  • If you participate, you may not participate in the Dutch COVID-19 vaccination program until 8 weeks after the start of the study. It is no problem to receive an authorized COVID-19 vaccine after that period.
  • If you are called up during the follow-up period of the study to obtain an authorized corona vaccine from the Dutch COVID-19 vaccination program, we will ask you to come to the hospital just before and after the vaccination for extra follow-up visits and blood tests. These additional follow-up visits are not mandatory. Do you choose to participate in these extra follow-up visits before and after the vaccination with an authorized vaccine? In that case you will receive a reimbursement of €25,- for each additional follow-up visit with blood collection on top of the reimbursement of €1000,-

The team


Clinical Researcher

drs. Merel Smit MSc

During the study 24/7 on call
06 1144 6136
contact

Principal Investigator

prof. dr. Benjamin Mordmüller


Clinical supervisor

dr. Matthew McCall