Yellow Fever Vaccination > Volunteers information

Information for volunteers

A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination

We would like to ask whether you would consider becoming a voluntary participant in our ongoing research effort to examine and to understand how the Yellow Fever vaccine works.

Below, we will describe the research involved as well as the consequences it will have for you should you decide to participate.

When you have read this written information and after you have talked to the vaccinating physicians and/or nurses, you are entitled to take time to deliberate before you decide whether to participate.

Please read the brochure "Before you make up your mind" (a translation of the coresponding Danish brochure about volunteering for clinical trials published by the Department of Research and Innovation), which is attached to this document.

If you wish, you have the right to bring an advisor (a friend, guardian etc) to the session with the vaccinating physicians and/or nurses.

Who can participate

To participate in the experiment you must

• be receiving a yellow fever vaccination for reasons other than this research project (typically, traveling abroad is the real reason for being Yellow Fever vaccinated)
• be able to donate a small blood sample before or at the time of vaccination
• be able to donate a larger sample of blood some 10 to 20 days after the vaccination (i.e you should still be in the Copenhagen area at that time)
• be between 18 and 66 years old
• not have donated more than more than 300 ml blood within the past two months
• not have anemia or any chronic heart ailments

About the experiment

We are investigating how our immune system reacts to the yellow fever vaccine. The purpose of any vaccine is to prepare the white blood cells of the immune system so they rapidly and efficiently can recognize and eradicate a particular invading microorganism (in this case, the yellow fever virus) if one should ever become infected. Unfortunately, we know very little about what parts of the yellow fever virus that are recognized by the white blood cells. We have considerable expertise in modeling immune responses and discovering immune targets. Investigating the immune responses following yellow fever vaccination is a great opportunity to test this knowledge in an environment that is safe, yet closely mimics the situation during a real infection.

What is the significance of this line of research?

For you personally, there are no immediate benefits. However, the results will of considerable benefit to medical sciences. Understanding what the immune system targets should enable many new approaches to medical intervention. By way of examples, one could search for relevant immune targets in more complex infections e.g. HIV, and generate new and improved vaccines against these infections; one could search for immune targets that are uniquely (or preferentially) expressed by tumor cells, and thereby generate a novel approach to cancer treatment; or one could search for those structures that are expressed by our own cells and in some individuals inadvertently attacked by our immune system thereby causing autoimmune diseases such as diabetes, sclerosis or rheumatoid arthritis, and eventually generate novel cures of these serious diseases.

If you should decide to participate in the investigation

We will:

• ask for information about who you are (e.g. name, address, email etc - and whether you have previously received yellow fever vaccination, and whether you have given blood recently).
• ask you to donate a small blood sample (40 ml) before or at the time of vaccination
• ask you to donate a larger blood sample (200 ml), which will be taken at the Rigshospitalet Blood Bank approximate between 10 and 20 days after the vaccination

Note - it is important that you can give us the first and second blood samples (therefore you should be able to donate the second blood sample before you travel)

• ask you whether you will allow us to contact you later (say 2-4 years after the vaccination) and at that time ask whether you would be available and willing to donate yet another blood sample. This would allow us to examine how their immune system reacts to yellow fever many years after the vaccination.

Note - any donation after the second donation is entirely optional. Even if you decide to stop after the second donation you can still enroll in the experiment.

What happens with your blood sample?

• Cells from the blood you give us will be purified and stored frozen in a cell bank
• The vials with the cells will be tagged with a code (i.e. without your name)
• The cells will be tested for their ability to respond to yellow fever
• The cells will be stored for up to 16 years
• If the cells should prove valuable in other research project such use would require re-authorization from you or from a science-ethical committee.

Possible side effects

There are very few side effects or discomfort in connection with donating blood. Apart from the needle puncture itself, bruising may occur on rare occasions. The size of the largest of the two blood donations corresponding to just under one half of a normal blood bank donation and will not significantly affect your blood percentage.

Registration and use of the information obtained during the investigation

Your personal data will be kept strictly confidential. Information that can be traced back to you personally will never be released. Results of the experiments will later be included in scientific articles, but always in anonymous form.

The results of the experiments will not in any way affect any treatment otherwise planned for you.

You will not know the outcome of these investigations (the basis for this decision is that the significance of any findings are unclear).

To safeguard ourselves against working with infected blood, we will conduct a routine blood bank analysis for possible infections (e.g. HIV, hepatitis C etc). If these analyses are positive, we will notify you of such outcome unless you have decided not to receive such information.

Termination of the investigation

It should be emphasized that participating in this investigation is entirely voluntary. You can opt out of the study at any time. Such a decision will not in any way affect your treatment.

The experiment may also be terminated if we deem it unsafe (i.e. if you have anemia and are unfit for a blood donation).

Financial support of the investigation

This investigation is conducted in cooperation between several research groups at the University of Copenhagen and the Technical University of Denmark, the Copenhagen University Hospital (Rigshospitalet), and at various vaccination clinics. The investigation will take 5-years to complete and it will include 200 vaccinee volunteers.

The study is supported financially by public funds including an allocation of approximately 35 million kr from the National Institutes of Health (NIH, USA).

Professor Søren Buus, University of Copenhagen has taken the initiative to study. He has no connection to the NIH. None of the researchers have any financial interest in the results of the study.

As partial coverage of vaccine expenses and transportation costs, we will pay you a small compensation of 250 kr. This amount will be transferred to your bank account (or sent to you by check) after the second blood donation. Similar compensation will be paid to the clinics drawing the blood.

This scientific experiment has been evaluated and approved by the scientific ethics committees for the Capital Region (protocol H1-2009-095). In addition, the project has been evaluated and approved by the Danish Data Protection Agency ("Datatilsynet") (license # 2008-41-2732).

Additional information about this investigation can be obtained from