3 OXFORD VACCINE GROUP - University of...

Towards the prevention of RSV: A major cause of infant death, A vaccine study involving healthy adults; 201974/RSV

PED-001; Study Information Booklet & ICF, 15/SC/0133, Version 3.1, Dated 22-Jun-2015 of 22

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OXFORD VACCINE GROUP

Towards the prevention of RSV: A major cause of infant death

A vaccine study involving healthy adults

Study Information Booklet

You are invited to take part in a study to test a new vaccine against Respiratory Syncytial Virus (RSV), which is an important cause of lung infection in children and

the elderly. The study is being run by the Oxford Vaccine Group, which is part of the University of Oxford, and is sponsored by GlaxoSmithKline Biologicals S.A. (GSK).

Before you decide whether to take part, it is important for you to understand what the study is about and what participation would involve. Please take time to read

the information carefully, and discuss with others if you wish. If anything is unclear or you would like further information please contact the study team (details below).

Contact Details Oxford Vaccine Group

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital

Oxford OX3 7LE Tel/Fax: 01865 857420

Email: [email protected]

Thank you for taking the time to consider taking part in this study.

Towards the prevention of RSV: A major cause of infant death, A vaccine study involving healthy adults; 201974/RSV PED-001; Study Information Booklet & ICF, 15/SC/0133, Version 3.1, Dated 22-Jun-2015

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Study Title:

A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in healthy adults

What is the Oxford Vaccine Group?

The Oxford Vaccine Group, which is part of the University of Oxford, is an independent research team of doctors, nurses and play assistants. We carry out research studies of new and improved vaccines for babies, young children, teenagers and adults and teach doctors and nurses about immunisations. In the past 5 years alone, over 7,000 participants in the Thames Valley area have taken part in our research studies.

Why have I been invited to take part?

We are inviting healthy adults aged 18 to 45 years old to take part in this study as this vaccine must be tested first in healthy adults before it can be given to children. We use various ways to contact potential volunteers, including the Electoral Roll or the National Health Applications and Infrastructure Services (NHAIS) who hold the central NHS patient database (Open Exeter). This database identifies all persons within the local area who are in the appropriate age range.

What is RSV and what is the study all about?

In this study we are testing a new vaccine against Respiratory Syncytial Virus, or RSV. This virus can cause respiratory infections such as bronchiolitis and pneumonia.

RSV affects all ages, but mainly babies, the elderly and people whose bodies cannot easily fight infections. RSV is dangerous for babies, whose lungs are still very small and whose body cannot fight infections very well yet. RSV causes:

Hospital admission in approximately 24 out of every 1,000 babies under 1 year of age in England.

An estimated 253,000 deaths worldwide every year, almost all in children. 90% of these deaths are in developing or underdeveloped countries.

A risk of breathing problems later in life in babies with severe RSV infection.

Severe disease in the elderly, in older children and in adults with problems with their immune system. It causes a similar amount of disease as seasonal influenza (the flu).

Infections (and re-infections) in healthy adults do occur. In this group, RSV infections may result in symptoms similar to a cold or no symptoms at all, but the infection can be passed on to vulnerable individuals (babies, the elderly and people who have problems with their immune system).


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So far, there are no approved vaccines available to prevent RSV. Because of this, a new RSV vaccine is being developed to protect babies from RSV disease, and this study will evaluate this vaccine. Approximately 72 participants will take part in this study.

Do I have to take part?

It is up to you to decide whether or not to take part in this research study. If you do decide to take part you must sign the pages at the end of this leaflet to show that you agree to be part of the study. This is called ‘giving consent’. You will receive a copy of this form. You should make your decision only after: 1. A study staff member has explained the study to you 2. You know the purpose of the study and the risks, and 3. You are willing to do what is asked of you in the study. Talk with your family, friends, and your General Practitioner (GP) to help you make your decision. You can take as much time as you like. You may change your mind at any time during the study. You may leave the study at any time, even if you have signed this form. You do not have to give a reason. For independent advice you can contact INVOLVE (www.invo.org.uk) which is a government funded national advisory group supporting those considering involvement in NHS, public health and social care research.

What vaccines are given in the study?

In this study, 2 different doses (low and high) of an RSV vaccine called ChAd155-RSV, will be tested. If you join the study, you would receive either one of the 2 different doses of the RSV study vaccine, or what is referred to as a control. In this case the control is a vaccine called Bexsero or it is a placebo (only water and salt). You would receive 2 doses of the same vaccine or the control about 4 weeks apart. The RSV vaccine (or Chad155-RSV vaccine) is made up of a carrier virus and 3 RSV proteins. The carrier virus is a chimpanzee adenovirus (known as Chimpanzee adenovirus 155 or ChAd155), which is not known to cause disease in humans.

The carrier virus has been genetically modified so that it cannot replicate (multiply) itself in your body, and so that it expresses three RSV proteins. The 3 RSV proteins present in the vaccine are important for the RSV virus to be able to infect human cells and multiply in your body. Antibodies produced by your immune system against those proteins are important to limit RSV infection and prevent RSV disease.


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By modifying the virus in this way it is anticipated that immunisation with this vaccine will be able to generate a targeted immune response in your body to those three proteins from the RSV virus. The aim of generating such a response is that it might mean your body can fight off a real RSV infection more easily and not become so unwell.

The vaccine does not contain the RSV virus and cannot cause RSV disease.

This vaccine has never been given to humans before. It has been given to animals and the results of those tests in animals have shown that the vaccine was capable of stimulating the immune system against RSV and was effective in preventing RSV disease in the animals tested.

Bexsero, is a licensed vaccine against a bacterium called capsular group B Neisseria meningitidis (MenB), which can cause meningitis (infection of the lining of the brain) and septicaemia (blood poisoning). The MenB vaccine and the placebo are used as controls in this study to allow comparisons with ChAd155-RSV vaccine. Participants will be randomly assigned into 1 of 3 different groups to receive the ChAd155-RSV vaccine, the MenB vaccine or the placebo. This means a computer programme will randomly assign participants to be in one of these groups by chance, similarly to tossing a coin. You and the study team cannot influence what group you are put in. You also would be ‘blinded’, meaning you would not know what vaccine or placebo you would receive. Most of the study team would not know what you had received either (except the team member giving you the vaccine or placebo). By ‘blinding’ it allows the study team to assess the real effect of the study vaccine. You would be told what you had received only in case of emergency or after the study is finished. This study is being done primarily to make sure that the vaccine is safe and understand how well it is tolerated by those who receive it. However, the study will also give some information on how it may help your body to fight RSV infections. This will also help to find out whether it might be able to protect babies.

What will happen to me if I take part and what would I have to do?

Since this is the first time the RSV vaccine is being given to people, we will do the study in 3 steps to make sure you are safe when taking part. Out of the 72 people who take part in this study, 16 will go in the first step. The low dose of the RSV vaccine will be tested in this step. Another 16 will go in the second step and about 40 other people will go in the third step. The high dose of the RSV vaccine will be tested in the second and third steps. You would be included in one of these 3 steps.


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People in the first and second step of the study will have a 1 in 2 (50%) chance of getting the RSV vaccine, 1 in 4 (25%) chance of getting the MenB vaccine and 1 in 4 (25%) chance of getting the placebo. People in the third step will have 3 in 5 (60%) chance of getting the RSV vaccine, 1 in 5 chance of getting (20%) the MenB vaccine and 1 in 5 (20%) chance of getting the placebo. In total, about 40 people will receive the RSV vaccine (8 people will receive the low dose and about 32 people will received the high dose), about 16 will receive the MenB vaccine and about 16 will receive placebo. Information about how the ChAd155-RSV vaccine, MenB vaccine or placebo you receive affects your body and your health will be collected through a number of tests and procedures. At different times during the study, a group of experts in GSK will look at the side effects to decide if it is safe to give a second dose or to vaccinate more people. The group of experts can also meet at any moment, if needed, to discuss the safety of the study. Please refer to the diagram on the next page for the different steps of the study. You will receive a card with study contact information. Keep this card with you at all times during the study. Show this card to the medical staff if you need emergency care during the study. The medical staff can then contact your study doctor if needed to ask about the vaccine or product you received.


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Who can take part in the study?

We are keen to recruit healthy volunteers who are:

Willing and able to take part – i.e. able to attend all visits

Aged between 18 and 45 years old

Willing to allow us to communicate with their GP and/or medical consultant to notify them of enrolment and to verify the medical history (including verifying your medical history by accessing your Electronic Patient Record, if applicable)

(Females) Willing to use effective contraception from one month prior to starting and for 2 months after the last vaccine

You would not be able to take part if you:

Have significant heart, liver, lung, kidney or neurological disease

Have a bleeding disorder meaning you cannot receive injections

(Females) Are pregnant or breastfeeding

Are currently participating in another clinical trial where you have/will receive an investigational medicine/vaccine or have received one within 30 days of receiving a vaccine in this study

Have received or plan on receiving a vaccine within 30 days of the first dose of vaccine in this study or within 30 days of the last vaccine. You would not be able to take part if you have ever received a MenB vaccine, an RSV vaccine or a simian (monkey)/ human adenoviral vaccine.

Have allergies to latex or any of the components of vaccines used in the study

Having received immunoglobulins or any blood product transfusion within 3 months of the first vaccine dose

Have or are planning on donating blood within 4 months of the start of the trial

Current alcohol or drug abuse

A body mass index of > 40 kg/m2, which is a measure of obesity

What happens in this study?

This study will last about 12 months and you would need to visit the clinic at least 12 times. During this time, you would need to have tests, visit the clinic on schedule, and tell us about any changes you experience such as how you feel after the vaccine has been given.


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At the screening visit

A clinical study team member would explain the study to you in detail, and you would have the opportunity to ask any questions. If you are still interested in participating we would ask you to sign the study informed consent form. Following this you would have the following examinations, tests or procedures to find out if you can be in the study.

Visit / Day Main study activities at this visit

Screening Visit Before Day 0

Signing of Informed Consent Form Eligibility check (to see if you can take part in the study):

Questions about your health and medical history

Physical examination (including height and weight)

Pregnancy test (only for women who can get pregnant) Blood sampling (around 10 mL - 2 teaspoons) Urine testing

We would ask for your consent as well to contact your GP to obtain any relevant medical history that may affect your participation in the study. If needed, the study doctor might ask for more blood or a urine test to be sure you are healthy before you can receive the vaccine.

During the study:

You would be expected to do the following things during the study:

You would need to come to our study clinic at the Churchill Hospital for 11 scheduled visits. The schedule/dates for these visits are shown on the next page.

You would be asked to tell your study doctor about other hospital or GP visits, unscheduled tests (lab tests, X-rays etc.) and unscheduled procedures.

You would receive 2 vaccinations (injections in your upper arm) 4 weeks apart. You would get the first vaccination during the first study visit after the screening period (at Visit 1) and the second one 4 weeks later at Visit 5.

After each vaccination you would need to stay at the clinic for 60 minutes so that you can be observed. Your vital signs (blood pressure, heart rate and respiratory rate) will be checked again to make sure you are well before you leave the clinic.

During the study visits, the study doctor or study staff would collect information to check the effect of the vaccine.


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These are summarised in the table below.

Visit / Day Main study activities at this visit

Visit 1 Study Day 0

Final check on eligibility (to see if you can take part):

Questions about your health/medical history

Physical examination

Pregnancy test (only for women who can get pregnant) Blood sampling (around 75 mL - less than half a cup) Temperature measurement Vaccination + 60 minutes observation + recheck of vital signs Receive Diary Card

Visit 2 Study Day 1

Questions about your health Physical examination Blood sampling (around 12 mL - about 3 teaspoons)

Visit 3 Study Day 3


Visit 4 Study Day 7

Return Diary Card Questions about your health and physical examination Blood sampling (around 68 mL - less than half a cup) Receive Diary Card

Visit 5 Study Day 30

Return Diary Card Questions about your health Physical examination Pregnancy test (only for women who can get pregnant) Blood sampling (around 75 mL - less than half a cup) Temperature measurement Vaccination + 60 minutes observation Receive Diary Card

Visit 6 Day 31 of the

study





Return Diary Card Questions about your health and physical examination Blood sampling (around 68 mL - less than half a cup) Receive Diary Card


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Return Diary Card Questions about your health Physical examination (if the study doctor thinks it is necessary) Blood sampling (around 75 mL - less than half a cup)


Questions about your health Physical examination (if the study doctor thinks it is necessary) Blood sampling (around 10 mL - 2 teaspoons)


Questions about your health Physical examination (if the study doctor thinks it is necessary) Blood sampling (around 10 mL - 2 teaspoons)

Blood would be taken at each visit. The amount would be between 10 mL (about 2 teaspoons) and 75 mL (less than half a cup) depending on the tests that will be done. The total amount of blood taken during the whole study (about 1 year) would be no more than 439 mL (about 2 cups), which is less than 1 “blood donation” to the UK Blood Transfusion Service. Your body would replace this blood quickly. There might be a case in which your blood needs to be retested or a urine sample taken to confirm test results. This might happen at your next visit or at an unscheduled visit that you would need to come to the clinic for. At this visit the study staff would take a sample of your blood (10 mL, 2 teaspoons) and collect a urine sample, as needed. Study Diary Cards: After each vaccination, you would have to complete 2 diary cards. One will cover the first 7 days after vaccination and you will be asked to take your temperature, measure any injection site reactions (e.g. redness or swelling) with a ruler and record if you’ve had any symptoms or taken any medications. You will also be asked to fill in another diary card to record whether you’ve had any medications, symptoms or have been seen by your GP or any other health professional from day 7 and up to a month after each vaccination. If you feel that you have a cold-like sickness during the study, we may ask to see you and check if you have RSV infection naturally. Either at your next clinic visit or at an unscheduled visit, the doctor would check you and might ask to test you for respiratory viruses by taking a nasal swab (sample from your nostrils).

How would being part of this study affect my lifestyle? When deciding whether to take part in this study, consider how the tests listed above and the visit schedule would affect your work and family schedules. Consider if you need transportation to get to the clinic. You may find that these tests and visits are inconvenient and require special effort. In addition, some tests may be uncomfortable. Ask us if you have any questions about the tests and procedures for the study.


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You would need to allow enough time for phone calls from study staff. You would need to allow enough time each day to complete your diary (i.e. 5 to 10 minutes). You would need to talk with the study doctor before you start any new medications. If you are a woman who can get pregnant, you would need to use adequate birth control while in this study. For the purposes of this study this would mean methods such as the oral contraceptive pill (combined or progestogen alone), hormonal injections/depots, male partner sterilisation or abstinence from heterosexual intercourse. Single barrier methods such as condoms alone would not be considered adequate (although condoms with spermicidal cream or a diaphragm would be). Check with the study team about what kind of birth control methods to use and how long to use them.

What are the alternative treatments available? So far, there are no vaccines available against RSV and there is no effective medicine to treat RSV infections. Treatments against RSV disease usually only work on the disease symptoms and do not work on the cause of the disease. Children ‘at risk’ of RSV infection (e.g. premature babies) may be given a synthetic (artificial) antibody as monthly injections over winter, but no such option exist for adults.

What side effects or risks can I expect from this study? You may have side effects while on this study. We would observe everyone in the study for any side effects. Side effects for all study procedures and vaccinations are outlined below. Side effects may be mild or serious. Some effects will stop shortly after receiving the vaccine In some cases, side effects can be serious, lasting or may never go away. It is important to notify the study team if you are at all worried about your symptoms. You may take medicines after you’ve received a vaccination to help lessen side effects (for example, if you have a fever you could take paracetamol to help treat it). Any medication you have taken during the study should be recorded in your diary card. If you have a severe reaction, we may give you medicines to assist you. Vaccination In general, the known risks following vaccination are minor and brief (lasting a few days). As with any vaccination, the following events could occur:

Pain, redness or swelling of your arm around the spot where the vaccine was injected

General: fatigue, headache, fever, gastrointestinal symptoms such as nausea (feeling sick), vomiting, diarrhoea or abdominal pain


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As with all injected vaccines, unexpected, severe allergic reactions may very rarely occur. An allergic reaction can be recognised by itchy skin rash, swelling of the face, difficulties in breathing and swallowing or by a sudden drop in blood pressure. If such reactions occur, they usually start very soon after vaccination. That is why it is important that you stay at the study site for at least 60 minutes after vaccination, where all medical equipment and personnel are available to treat an allergic reaction. RSV vaccine As it is the first time that the study vaccine will be tested in humans there might be side effects that we don’t yet know about. Similar vaccines to protect against other diseases have already been used in people. As soon as a new side effect is known, we will tell you. Some information could also come from animal studies. We will also keep following this up during the study. Animal studies conducted to date have shown this vaccine to be capable of stimulating the immune system against RSV. Some changes in laboratory values were seen 24 hours after injection, but most of them returned to normal within 7 days and they did not seem to cause any clinical symptoms or disease.

MenB vaccine (Bexsero) Like all vaccines, the MenB vaccine can cause side effects, although not everybody gets them. If there are side effects, they usually happen in the first 3 days after vaccination and they do not last for a long time.

The most common side effects of the MenB vaccine are (seen in more than 1 out of 10 vaccinated people):

Local side effects at the injection site: pain, swelling, hardening and redness.

General side effects: headache, nausea (feeling sick), generally feeling unwell, muscle pain and joint pain.

The study doctor can give you more details about this vaccine. If new information about this vaccine is known while the study is ongoing which may affect your safety, the study doctor will let you know.

Placebo

Vaccination with placebo does not usually cause side effects other than the ones known for any injection.

Blood sampling

When giving blood you may feel faint or experience mild pain, bruising, irritation or redness from the needle. These may clear up in a short period of time.


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Nasal swabs Nasal swabs can be uncomfortable but this should also clear up in a short period of time. Call the study doctor right away if you have any side effects that you think are serious. What happens if something abnormal or medically important is detected on your tests? All the safety information related to you (e.g. diary cards, blood tests) would be continuously examined during the whole study period. If anything serious in relation to your health is detected, you would be immediately informed and a plan of management would be decided with you and your GP.

If you have private medical insurance you should check with the company before agreeing to take part in the trial to ensure that your participation would not affect your medical insurance.

What about pregnancy and breastfeeding? You should not take part in this study if you are pregnant or breastfeeding. As this is the first time this vaccine will be given to humans, there is no information about how the vaccine could affect an unborn baby. If you get pregnant during this study, inform the study doctor right away. If you get pregnant during the study, you will not receive any more vaccine but may remain in the study for follow-up. You may be asked questions later about the pregnancy and the baby. Please refer to the previous section on lifestyle for advice on birth control.

What are the benefits of taking part?

Information from this study may help doctors learn more about RSV and the RSV vaccine. This information may help us to make a vaccine that can protect babies against RSV. RSV vaccine: If you are vaccinated with an RSV vaccine, this may not be of any benefit for you. MenB vaccine: If you are vaccinated with the MenB vaccine you may be protected against some types of meningococcal disease (the bacterium or germ that can cause meningitis and blood poisoning). Placebo: If you receive the placebo, there is no benefit.


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Do I have to stay in the study?

Your participation in this study is voluntary. You may choose to stop being in the study at any time, without giving a reason. If you do give a reason, then it may be recorded. Tell the study staff if you want to stop being in the study. Your decision will not affect your medical care now or in the future. It will not affect other benefits you receive outside of the study or medical care you receive. You may be asked to leave the study if:

The results of certain tests show that you are not eligible to take part in this study or to receive the study vaccine

You do not attend visits or follow study procedures

You are diagnosed with any new health problems which could impact on your participation in the study

You become pregnant or decide that you want to become pregnant

The study doctor thinks it is best for you not to take part New information may become available or known that might affect your choice to stay in the study. Such information will be shared and discussed with you. This new information might include:

Safety issues with the study vaccine

Evidence that the study vaccine may not work The study sponsor, the regulatory authority, or your study doctor may choose to stop the study at any time. We will give you the reason at that time. What happens if I withdraw consent? If you decide to withdraw consent, this means you decided that no more information about your health could be collected for this study unless you gave permission for us to do so. You and the study doctor will need to discuss this, but we may ask you to allow us to phone you or have you visit the study centre (e.g. for a follow-up visit to check for any side effect you may have had from the study vaccine). The study team may find out information about your health after you have left the study. The study team will send this information to the sponsor if it involves the safety aspect of the vaccine and would notify you of any concerns. With your permission, we would also notify your GP. All the information you gave us and the samples we’ve obtained before you left the study would still be used for the study.


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It is possible to stop receiving the study vaccine and still stay in the study. Even if you do not want to keep receiving study vaccine, your health information is still very important information for the study and you would be asked to continue the scheduled visits and to be in contact with the study staff. This also may include the study staff contacting you or others to learn about your well-being. It is very important for the study that the study staff be able to collect health information about you until the study ends. We would ask you provide contact details of a person who can act as a 24 hour contact in the case of an emergency or needing to contact you urgently, and provide contact details of any doctors treating you. We may contact these people if we are not able to contact you during the study. What happens if I get hurt taking part in this study? The sponsor will pay you compensation if you are hurt by a vaccine or a procedure you needed only as part of this study. You study doctor can give you a copy of the guidelines for this type of injury. Signing this consent form does not change any legal rights you have. If you become ill or are hurt while you are in the study, you would be eligible to receive treatment through the NHS as you normally would. Would my information be kept private and what would happen to it? It is very important that your personal and medical information stay confidential and secure. The sponsor will protect your information in accordance with current law. When you sign this consent form you agree that the sponsor can use your personal and medical information as described here:

Your personal and medical information may be checked by the sponsor and others (like agencies that approve and monitor studies). This is to make sure that the study is being run properly.

Besides that, only the researchers at this study site can use information that identifies you (such as name and address) and only for the purpose of the study.

Your study information collected during the study will be labelled with a code number (for example, 1234782). It will not include your name or address. The study team will have the link between your name and the code number.

The link between your name and the code number will not be shared. Only the code number and coded information will be sent to the sponsor.

The sponsor will use your coded information for research only. This may include research looking at improving the quality and efficiency in conducting clinical research trials in general.


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The sponsor may:

keep your coded information electronically, and analyse it by computer to find out what the study is telling us. This may be done by the sponsor or a third party, in which case the sponsor will ensure that the third party is required to keep your data secure,

share the information with regulatory agencies that approve new vaccines and medicines,

share the information with people who check that the study is done properly (like the ethics committee or review boards),

combine the information with results from other studies to learn more about the vaccine and this disease and related diseases. This may help us to assess the risks and benefits of the sponsor (or other) vaccines or medicines, or to improve disease understanding,

publish study results for medical journals, meetings and on the internet for other researchers to use; your name will not appear in any publication,

share coded information with other companies, organisations or universities to carry out research. This may include research looking at improving the quality and efficiency in conducting clinical research trials in general.

Personal and medical data collected during the study may be moved, stored and used in the country where you live or another country where the sponsor or those working with the sponsor work. Use of this information may take place in countries with lower data protection rules than the country where you live. The sponsor will make sure that if your data are moved to another country, it will still be treated as stated in this Informed Consent Form. A description of this clinical study will be available on the sponsor’s Clinical Study Register: http://www.gsk-clinicalstudyregister.com/ and may also appear in clinical trial/study registries in countries in which the clinical study is conducted. The sponsor will be the owner of the study results. The sponsor plans to use the results, and may get patents, or sell the vaccines in the future, or make profits other ways. You will not be paid any part of this. If you withdraw your consent for use of your personal information, you will no longer be able to continue in the study. However all the information and samples collected before you left the study, or at any follow up visit, will still be used as set out in this consent form.

http://www.gsk-clinicalstudyregister.com/


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At any time, you may ask the study team to see your personal information and correct it, if necessary. In some circumstances, you may not be able to access your study information while the study is ongoing. However, the study doctor will share any important medical information if it is relevant to your health during the course of the study. You must not take part in too many studies because it is not good for you. The sponsor’s clinical units and other units like ours in the UK subscribe to a database of volunteers. The Over Volunteering Prevention System (TOPS) gives us information about volunteers who take part in studies. We will enter into the database:

your National Insurance number (if you are a UK citizen); or

your passport number and country of origin (if you are not a UK citizen); and

the date of your last dose of study vaccine.

What would happen to my samples?

As part of the study, you will be asked to give samples of your blood and possibly nasal swab (samples from your nostrils) and urine. Your blood and nasal swab samples may be sent to GSK or other laboratories working with GSK including those outside the UK to:

measure how your body reacts to the study vaccine

ensure the quality of the tests we use for the study vaccine and/ or disease,

improve tests and develop new tests linked to the study vaccine and/or disease. These tests will never include testing related to your genes’ hereditary characteristics.

Your samples will be given a code so that it does not directly identify you. Your samples will be kept for a maximum of 20 years from the end of the study (the last visit of the last subject to complete the study). Any sample remaining at that time will be destroyed. Optional tests on your samples:

If you agree, your sample(s) may also be used for future research. For example, research related to the study vaccines and/or disease to improve scientific understanding. GSK will always ask approval for this research to an independent ethics committee or independent review board. You can state on the last page if you agree to this or not. There is no problem if you do not agree. You can still be part of the study.


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Who is funding the research? GSK is a group of companies that creates and makes medicines and other health products. The Belgian company GlaxoSmithKline Biologicals SA, which is part of GSK group, is paying the University of Oxford to run this study. You can discuss this information in private with your doctor or family to talk about your healthcare or to decide about taking part in this study.

Who has reviewed the research?

This study has been reviewed and approved for conduct by South Central Berkshire Research Ethics Committee, one of the national research ethics committees. This committee reviews research studies to protect the rights and wellbeing of the people taking part. The study also has the approval of the Oxford University Hospitals NHS trust research and development department. In addition the Medicines and Healthcare products Regulatory Agency (MHRA) has independently reviewed and approved the conduct of this clinical trial.

With your permission, your study doctor would contact your GP to inform him/her that you are participating in this study.

If you decide to take part, you would be given a copy of this information sheet and of your signed consent form, to keep.

What would happen to the results of the research study?

The results of this research study will be published in a scientific medical journal but this would not happen until long after the study is completed. Your individual results would not be identifiable nor would you be identified in any report or publication. Once the study is published we would send out a summary of the results to all participants. You would not have access to your personal results.


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Reimbursement

Study participants would be reimbursed for their time, travel and inconvenience of taking part in the study. The maximum reimbursement for any volunteer is who completes the whole study is £540. All participants will be reimbursed for their time, travel and the inconvenience based on the following figures:

Travel expenses: £15 per visit

Inconvenience of blood tests: £10 per blood donation

Time required for visit: £20 per visit

Inconvenience of nasal sampling: £10 per sample

The sum reimbursed is on a pro rata basis, so, if for example, you choose to withdraw half way through the study we would calculate your reimbursement based on the visits you have attended and samples that have been obtained.

Payments are made directly by bank transfer in instalments during the study. For this reason we would require participants to provide their bank details at screening. Bank details would be kept confidential.

You may also receive reimbursement for any unscheduled visits you attend (if you have symptoms of a possible RSV infection). You would be reimbursed £55 per unscheduled visit, up to a maximum of £165 (equivalent of 3 unscheduled visits). If you do not require any unscheduled visits, you will not be reimbursed for this amount.

What should I do if I’m interested in taking part?

If you decide that you are interested in taking part then please call or email us. One of the study team would telephone you to briefly discuss the study further and answer any immediate questions you might have.

If you were still keen to take part we would be happy to arrange a visit at the Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) on the Churchill Hospital site.

What if I wish to complain?

If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should contact the Oxford Vaccine Group (telephone 01865 857420) or email [email protected].


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What do I do now?

Thank you for considering taking part in this study. You do not need to make a final decision straight away. If you wish to discuss any element of the study further, then please contact us by either

telephone (01865 857420)

website (trials.ovg.ox.ac.uk/rsv)

email ([email protected])

Yours sincerely,

Dr Matthew Snape Chief Investigator Consultant Vaccinologist and Paediatrician Honorary Senior Clinical Lecturer

Prof. Paul Klenerman Principle Investigator Professor of Immunology Group Head Consultant Physician

Dr. Paola Cicconi Clinical Research Fellow

Mary Smith Lead Research Nurse


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OXFORD VACCINE GROUP

Towards the prevention of RSV: A major cause of infant death A vaccine study involving healthy adults

Study Number:

Centre Name:

Participant Consent Form Study Title: A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in healthy adults. If you agree with each section below, please INITIAL the box: NB. All boxes below need to be initialled in order for the participant to be enrolled in to the study. INITIALS

1) I have read and understood the information sheet (V3.1, dated 22-June-2015) for the above study and I confirm that the study procedures and information have been explained to me. I have had the opportunity to ask questions and I am satisfied with the answers and explanations provided.

2) I have been given time and opportunity to read the information carefully, to discuss it with others and to decide whether or not to take part in the study. I understand that my participation in this study is voluntary and that I am free to withdraw from the study at any time, without giving any reason, without my medical care or legal rights being affected, the study doctor may ask me to leave the study at any time and I cannot be in another study while I am taking part in this study.

3) I understand that sections of my medical notes may be looked at by responsible individuals from GlaxoSmithKline Biologicals S.A., companies acting on their behalf or regulatory authorities or the NHS Trust where it is relevant to my taking part in research. I give permission for these individuals to have access to my records.

4) I have been given the names of study staff whom I can call.

5) I agree to my GP being informed about my participation in this study.

6) I agree that my data/sample(s) can be transferred outside the European Union.


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7) I know what will happen to my blood samples.

8) I agree to my National Insurance (if UK citizen) or Passport number being used to register me on TOPS. I agree that if a conflict is found on TOPS OVG can share relevant information with other research groups and source relevant information from other research groups.

9) I I freely agree to take part in this study.

Participant Consent Form for Optional Research Please INITIAL beside YES/NO to the following questions. By answering “No” to any section will not influence your participation in the clinical study:

1) I

My samples may also be used for future research (at the time of the study or after the study is finished) not described in this form, for the purposes of improving scientific understanding of vaccines other than the study vaccines and/ or disease the study vaccines are designed to prevent. GSK will always ask approval for this research to an independent ethics committee or independent review board. I understand that if I select “No”, I can still take part in the study

YES ____ NO ____

Please print and sign your name below and add today’s date:

__________________

___________________

_________________

Name of participant Signature Date

__________________

___________________

_________________

Name of person taking consent Signature Date


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