information for volunteers - Department of Immunology & Microbiology

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Here, you will find information on participating in our ongoing research
effort to understand how the Yellow Fever vaccine works. You will be able
to read the information. If you are able to do so, please print it, fill in
wherever possible and bring the material with you when you are going to
get your Yellow Fever vaccination. Otherwise, we will provide you with a
copy of the documents at that time.
Our website can be found at www.gulfebervaccination.dk
A complete analysis of the T cell
epitopes induced by Yellow Fever
virus vaccination
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
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TABLE OF CONTENTS
INFORMATION FOR VOLUNTEERS .......................................................................................................................................... 4
Who can participate ...........................................................................................................................................................................................4
About the experiment .......................................................................................................................................................................................4
What is the significance of this line of research? ..................................................................................................................................5
If you should decide to participate in the investigation ....................................................................................................................5
What happens with your blood sample? ..................................................................................................................................................5
Possible side effects ...........................................................................................................................................................................................6
Registration and use of the information obtained during the investigation ............................................................................6
Termination of the investigation .................................................................................................................................................................6
Financial support of the investigation .......................................................................................................................................................6
DECLARATION OF INFORMED CONSENT ............................................................................................................................. 8
QUESTIONAIRE................................................................................................................................................................................. 9
INFORMATION ABOUT PLACE OF VACCINATION .......................................................................................................... 10
INFORMATION ABOUT THE BLOOD BANK AT RIGSHOSPITALET .......................................................................... 11
THE RIGHTS OF A VOLUNTEER IN A BIOMEDICAL RESEARCH PROJECT............................................................ 12
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
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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 section about ”The rights of a volunteer in a biomedical research project” attached at
the end of this document. This is an excerpt and translation of the Danish brochure about volunteering for
clinical trials published by the Department of Research and Innovation. (the Danish version can be found
on our website www.gulfebervaccination.dk).
If you wish, you have the right to bring an advisor (a family member, a friend, guardian etc) to the
session with the vaccinating physicians and/or nurses.
Who can participate
To participate in the experiment you must
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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
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
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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.
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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 reauthorization from you or from a science-ethical committee.
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Possible side effects
Der er meget få bivirkninger eller ubehag i forbindelse med at give blodprøver. Ud over selve stikket
kan der en sjælden gang forekomme blå mærker. Størrelsen af den største af de to blodprøver svarer til
lidt under en halvdelen af en normale portion blod for en bloddonor og vil ikke væsentlig komme til at
påvirke blodprocenten.
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.
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Dette videnskabelige forsøg er bedømt og godkendt af De Videnskabsetisk Komitéer for region
Hovedstaden (protokol H1-2009-095). Desuden er projektet anmeldt og godkendt af datatilsynet
(tilladelse #2008-41-2732).
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).
Yours truly,
Søren Buus, Professor
Laboratory of Experimental Immunology
University of Copenhagen
Additional information about this investigation can be obtained from Professor Søren Buus, University
of Copenhagen, Panum 18.3.12, Blegdamsvej 3, 2200 Copenhagen (tel. 3532 7885, click for email to
Søren Buus) or from Project Manager, associate professor Anette Stryhn, University of Copenhagen,
Panum 22.3.14, Blegdamsvej 3, 2200 Copenhagen (tel. 3532 7884, click for email to Anette Stryhn)
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
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DECLARATION OF INFORMED CONSENT
Concerning: ” A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination”
Declaration from the volunteer:
I have received verbal and written information, and I know enough about the purpose, methodology,
advantages and disadvantages to say yes to participate.
I have been informed that it is voluntary to participate and that I can revoke my commitment to
participate at any time and that doing so will not in any way affect my current or future rights to treatment.
I consent to participate in this investigation, and to having blood collected for storage of white blood cells
in a cell bank. I have received a copy of this “Informed Consent” and a copy of the written participant
information on the project for my own use.
Name of the volunteer: _____________________________________________________
Date: __________ Signature: _________________________________________________
I have been informed that my blood will be examined using routine blood bank tests for infectious
diseases such as HIV, hepatitis C, etc. If these turn out to be positive, I will be contacted by the Copenhagen
University Hospital (Rigshospitalet) Blood Bank, unless I have opted not to receive such information.
Yes, I want to be contacted about any discovery of infectious diseases
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No, I do not want to be contacted about any discovery of infectious diseases
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You will have to give two blood donations, one at the time of vaccination and another some 10 - 20 days
after vaccination. If possible, we would also like to contact you later (e.g. 2 - 4 years after vaccination) and
ask you whether you are willing to give another blood donation.
Yes, I give my permission to be contacted for any additional blood donation
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No, I do not give my permission to be contacted for any additional blood donation
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I authorize that the Danish health authorities can inspect my health records until 15 years after the
completion of these investigations (according to § 2.1 of the Law on Medical Confidentiality). This
authorization applies only to information that is related to the investigation and may be revoked at any time.
Such information will be treated confidentially.
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Statement by the persons responsible for informing the volunteer
I certify that the volunteer has received verbal and written information about the experiment, and been
given ample opportunity to ask questions. It is my conviction that this information is sufficient to allow the
volunteer to make an informed decision about participating in the experiment.
Name of the person giving information __________________________________________________
Date: __________ Signature: _________________________________________________
Person responsible for the investigation: Søren Buus, Lab. for Exp. Immunol., University of Copenhagen
Date: __________ Signature: _________________________________________________
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
QUESTIONAIRE
In connection with the "A complete analysis of the T cell epitopes induced by Yellow Fever virus
vaccination", we will ask you to fill out the questionnaire below:
Name:
CPR #:
Address:
Ethnicity:
(e.g. Danish; this information is voluntary)
Email:
Yes
No
I have previously been vaccinated against Yellow Fever
If yes, when?:
Will you be receiving any other vaccination than the Yellow Fever vaccine?
If yes, which?:
Have you within the past two months been donating blood in excess of 300 ml?
Do you want to be reminded by email about making reservations for the second
blood donation?
Do you want to be reminded by SMS about making reservations for the second
blood donation?
If yes – what is you mobile phone number:
Do you want the compensation of 250 DKK to be transferred to your bank
account?
Registration #:
Account #.:
If yes, please state your bank account information
Bank name:
If no, your compensation will send via check to the address given above
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
INFORMATION ABOUT PLACE OF VACCINATION
The Medical Office of the Danish Shipowners' Association
Amaliegade 33 (Entry D)
1256 København K
Vaccinations and consultation takes place (NB - only by prior appointment)::
Monday to Friday: 8:30 to 14:00
Bookings:
Monday to Friday: 9:00 to 14:00
Telephone: 3348 9263 or 67
Click here to send an email to The Medical Office of the Danish Shipowners' Association
Click here for the website of The Medical Office of the Danish Shipowners' Association
Click here to find the Medical Office of the Danish Shipowners' Association on a map
REMEMBER TO SAY THAT YOU WANT TO PARTICIPATE IN THE
"YELLOW FEVER EXPERIMENT"
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
INFORMATION ABOUT THE BLOOD BANK AT
RIGSHOSPITALET
The second blood donation will be drawn some 10-20 days after vaccination at the “Blood Donor
Collection”, Section 9501, Entrance 95, Blood Bank, Blegdamsvej 56 (opposite Rigshospitalet),
DK-2100 Copenhagen Ø
Call and book an appointment with
Nurse Birthe Brøndum
Region Hovedstadens Blodbank
Rigshospitalet
Telephone +45 3545 0909
Opening hours for both appointments and blood donations are:
Monday, Tuesday and Thursday: 08.30 to 14.30
Wednesday: 11.00 to 15.00
Friday: 08.30 to 14.00
Click here to find Rigshospitalets Blood Bank on a map (here you can also find information on
buses and parking facilities)
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
THE RIGHTS OF A VOLUNTEER IN A BIOMEDICAL
RESEARCH PROJECT
As a participant in a biomedical research project, you should know that:
• your participation in a research project is completely voluntary and can only be done after you have received both
written and oral information about the research project and signed an “Informed Consent” form
• you can at any time - orally, in writing or by other clear indication - withdraw your consent to participate and
withdraw from the research project. Withdrawing does not affect your rights to present or future treatments, or
other rights that you may have
• you have the right to bring a family member, friend or an acquaintance with you to the information interview
• you are entitled to deliberation time before you sign the “Informed Consent” form
• information about your health, other purely private matters and other confidential information about you which
may arise as a consequence of the research project are subject to confidentiality
• storage of information about you, including information from your blood and tissues, is governed by rules of law
concerning the processing of personal data and rules of law concerning health
• there is a possibility of gaining access to experimental protocols through disclosure provisions of the Freedom of
Information Act. This means that you can access all documents pertaining to your participation in the trial, except
those parts which contain trade secrets or confidential information about others
• there is a possibility to launch complains and get compensation under the rules of law on complaints and redress
within the health care system
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A complete analysis of the T cell epitopes induced by Yellow Fever virus vaccination
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