A Phase I Study to Assess the Safety of HIV and Hep C Vaccines Candidates When Given Separately or in Combination
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1 A Phase I Study to Assess the Safety of HIV and Hep C Vaccines Candidates When Given Separately or in Combination Sponsor: University of Oxford EudraCT No.: REC: South Central Oxford A REC Ref. No.: 14/SC/0195 PARTICIPANT INFORMATION LEAFLET Thank you for showing interest in this study. Before you decide to take part, it is important that we explain why this research is being done and what it will involve. You should be aged years, Hepatitis C (Hep C) and HIV-negative, and healthy. Women who are interested in participating should not be pregnant or intending to become pregnant during the study period. Participating in this trial does not mean that you will become immune to HIV or Hepatitis C. If you take part, we will advise you on how to protect yourself against HIV and Hepatitis C infection. Please take time to read the following information carefully and discuss it with friends, relatives or your GP if you wish. Please ask us if there is anything that is not clear or if you would like more information. Why is this study being done? Hep C and HIV are both common infections. By the end of 2010, there were 2.3 million people in Europe living with HIV, and over half of these people were co-infected with the Hep C virus. Vaccination is the most effective way to prevent many infectious diseases, but developing effective vaccines against HIV and Hep C is extremely challenging. One of the main reasons for this is the enormous variation in Hep C and HIV types around the world. This is caused by the extraordinary ability of the viruses to change their genes. Oxford University researchers have developed vaccine candidates for both HIV and Hep C and have tested these in people. All of the vaccines to be given during this study been shown to be safe and able to induce an immune response. However, the aim of the study is to find out whether vaccines for HIV Page 1 of 10
2 and Hep C can, when given together, induce immune responses that are similar in strength to when each vaccine is given separately. Many licensed vaccines are given as combinations, such diphtheria, tetanus, whooping cough and polio. The advantage of combined vaccinations for many diseases is that fewer clinic visits are needed and there is less chance of any of the vaccine components being missed. Because many people in the world are at risk of both HIV and Hep C it would be an advantage to prevent both infections with as few immunisations as possible. What are the vaccines being tested in this study? The vaccines being tested in this study each consist of two parts. The first part is known as a carrier (also called a vector ). The carriers are harmless viruses: a chimpanzee adenovirus called ChAd or AdCh, which is similar to human common cold viruses, and a type of smallpox vaccine called modified vaccinia virus Ankara (MVA), neither of which can cause disease in people. The second part of each vaccine contains segments of the genes of the HIV or Hep C virus. The HIV and Hep C components of the vaccines are completely synthetic and do not contain live HIV or Hep C, therefore they cannot give people Hep C or HIV infection, or AIDS. The vaccines are called AdCh3NSmut1 ( Hep C1 ), MVA-NSmut ( Hep C2 ), ChAd63.HIVconsv ( HIV 1 ) and MVA.HIVconsv ( HIV 2 ). What would I be vaccinated with? During this study, 32 individuals will be allocated into three groups. The first group of 8 individuals will receive two Hep C vaccines by injection the first will be Hep C1 and will be followed eight weeks later by Hep C2. The second group of 8 individuals will receive two HIV injections the first will be HIV 1 and will be followed eight weeks later by HIV 2. The third group of 16 individuals will receive four injections for HIV and HCV together. The first two injections will be given at the same time, one of HIV 1 and one of Hep C 1. This will be followed 8 weeks later by two more injections, one of HIV 2 and one of Hep C 2. Do I have to take part? It is entirely your decision as to whether or not to take part. If you do decide to take part you will be asked to sign a consent form. After you have done so, you are still free to withdraw at any time and without giving a reason. How often do I need to attend? You will be asked to attend for 12 study visits over a period of 8 months. Page 2 of 10
3 What do I have to do if I agree to take part? Screening Visit On the first visit (screening visit) the study doctor or nurse will discuss the study in detail with you to make sure that you fully understand what the study is about and what is involved if you decide to take part, and that you are happy to give written consent to take part in the study. If you decide to take part we will give you a copy of the consent form that you have signed which you can keep for your records together with this information sheet. We will give you an appointment schedule for the study visits. If appropriate, we will ask you to ensure that you use effective contraception throughout the study. We will ask you questions about your health and any medications you are taking and give you a physical examination. During the physical examination, we will measure your weight and vital signs, including pulse, blood pressure and temperature. We will also ask questions to ensure that you are not at risk of HIV and Hep C infection. A blood sample and a urine sample will be taken in order to confirm that you are eligible to take part. The urine sample will be used to test for protein and glucose, as well for pregnancy if you are female. The blood sample will be used for tests including for HIV, Hep C and Hep B infections. These tests will be explained to you in detail. If we identify any reason that would prevent you from taking part in this study this will be discussed with you. If a minor abnormality is noted on a screening blood test, a repeat test might be required to verify it. We will see you within two weeks to give you the results and discuss whether you might still be eligible for vaccination. We will ask you to refrain from participating in other clinical trials at the same time. In addition we will ask your permission to register you on the TOPS database ( which is a confidential national database of healthy volunteers and when they take part in studies, to minimise the risks that can come from over-volunteering. You will be asked you provide your National Insurance number if you are a UK citizen or passport number and country of origin if you are not a UK citizen. Vaccination Visits On the vaccination visits you will be given an injection into the muscle over the shoulder region of one or both arms, depending on which group you have been assigned to. We will monitor you for between 30 minutes and 1 hour at the clinic to ensure that there is no serious reaction to the vaccine(s). Page 3 of 10
4 Before going home, you will be given a diary card and telephone number(s) to call the doctor or nurse in case you have any side effects or concerns about the vaccine. During the next three days you will be asked to keep a daily record of your temperature and any flu - like symptoms that you might experience. A doctor or nurse will telephone you on the third day after the vaccination to check whether you have had any symptoms or concerns since the first check-up on the day after vaccination. Subsequent Visits On every subsequent visit we will ask questions about your health and, if necessary, we will carry out a physical examination. You will have between 25 and 90 ml (roughly 1½ 6 tablespoons) of blood taken at each visit (on average, just under 4 tablespoons per visit) with a total of no more than 670 ml taken over a period of 8 months. 670 ml is less than the amount that would be taken from regular blood donors at a Blood Donation Centre during an 8-month period. What will happen to the blood samples that I give? The blood tests will include a full blood count, blood chemistry and liver function tests at selected visits, to ensure that the vaccines are safe. In addition, a blood sample will be taken at each visit for research laboratory tests that will measure your immune response to HIV-1 and HCV, evidence of other infections, and your Human Leukocyte Antigen (HLA) tissue type (similar to blood group). The HLA typing is the only genetic test which will be performed. Some of each sample will be stored at each visit for future tests. Blood samples will be labelled with your unique study code only, before sending to the appropriate laboratory for analysis or storing for future testing. If you choose to withdraw from the study, any of your anonymised samples collected prior to withdrawal may be used for future tests. Page 4 of 10
5 The chart below gives a summary of what will happen at each visit: Number of visits 12 Duration of study 8 months (238 days) Vaccination visits Day 0 and 56 Blood samples Screening visit, days 0, 1, 7, 14, 28, 56, 57, 63, 84, 98 and 238 Urine sample Screening visit Pregnancy test (if applicable) Screening visit, day 0 and day 56 Physical examination Screening visit, days 0, 7, 28, 56, 63, 84, 98 and 238 What are the risks of taking part? The HIV and Hep C vaccines have each been given to healthy volunteers with no significant or serious side effects. For this reason, we do not expect that giving the HIV and Hep C vaccines together will cause any harm. However, we do not yet know whether there are any particular risks associated with the vaccinations being combined in this study. Risks of vaccination The most common side effects we have seen when the HIV and Hep C vaccines are injected into the shoulder muscle are aching and sometimes redness at the injection site, which can develop over a few days. In addition, tiredness and occasionally flu -like symptoms can develop over 2 days following the injection but these symptoms usually settle without treatment. We do not expect to see any serious adverse reactions when these series of vaccines are given. No serious side effects were observed in people receiving these vaccines individually. However, it is possible that any new combination of vaccines may produce new and unexpected side effects in humans. Any vaccination has the potential to cause the following: Redness, pain, swelling, itching, bruising, a warm feeling Flu-like symptoms such as fever, chills, muscle aches and pains, headaches, nausea, dizziness, fatigue Page 5 of 10
6 Allergic reactions such as an itchy rash, low blood pressure, sudden body swelling, serious breathing difficulty A temporary ache around the injection site For these reasons, we will observe you in the clinic for 30 minutes to 1 hour after vaccination. Risks of taking blood samples (venepuncture) Having blood taken may cause discomfort, bleeding or bruising where the needle enters the body and, in rare cases, light-headedness and fainting. We do not foresee that the amount of blood taken during the study will cause harm to your health. In similar studies we have conducted previously at the University of Oxford, no-one has developed anaemia during this time. However, we will check for anaemia at regular intervals during the study. Incidental findings If at screening or any time during the study a blood sample indicates that you may be positive for HIV or Hep C, we will take a second sample to confirm this result. In the event that this is a true positive result we will discuss the implications with you and refer you for treatment and/or support. False positive results on Hep C or HIV-1 tests As a result of vaccination with Hep C1 or Hep C2 you may test positive for antibodies against Hep C and these antibodies may persist in the future. This is a result of the vaccination and NOT because of Hep C infection. There is a simple blood test which can tell if you have contracted Hep C: this test, called PCR (polymerase chain reaction), is able to detect even small amounts of virus in the blood. Before and after the trial we will do PCR to verify that you are not infected with the Hep C virus. The test can be repeated in the future if you need to reassure yourself that you have not contracted Hep C infection. The presence of antibodies that you might have developed as a result of the vaccination will not alter the result of the PCR test. If you do develop antibodies to the Hep C virus we will, with your permission, write to your GP explaining this and give a copy of the letter to you to keep for the future. The text of the letter will be as follows: The individual named above participated in a trial of an experimental vaccine against Hepatitis C Virus (HCV) conducted at Oxford University. At enrolment the individual was tested for HCV antibodies and also for the presence of the virus by polymerase chain reaction (PCR) analysis. Both these tests were Page 6 of 10
7 negative. Tests for the presence of the virus by PCR at the end of the trial were negative and we can confirm that at this point the individual had not been exposed to HCV and was not a carrier. As a result of the vaccination, this individual has have generated antibodies against HCV proteins, which will result in a positive response in a HCV antibody screening test. This test result should not be taken as a marker of current or previous infection with HCV and has no impact on their health status. They present no risk of transmission of HCV; this status can be confirmed if necessary by analysis of plasma for HCV viral RNA by PCR. However, according to the current regulations of the National Blood Service, HCV antibody positive tests results will exclude the individual from being a blood or tissue donor as long as they remain positive, although it will not necessarily impact upon the ability to be an organ donor." There is a very low chance that vaccination with the HIV vaccines may also cause some HIV-1 tests to give false positive results following vaccination. The chance of a false positive HIV-1 test result is very low because the vaccines contain only fragments of HIV, not entire natural HIV proteins. If this does occur, we will test again using different methods that will be able to distinguish true infection from a result due to vaccination and we will provide an explanatory letter for your personal records and for your GP. Social harms It is possible that by taking part in this study, others may perceive you to be at risk of HIV or Hep C infection or stigmatise you. If you have any concerns or difficulties, trial staff will provide assistance and support. Risks associated with other HIV vaccine candidates in other trials Many clinical trials have tested the safety of other HIV vaccine candidates, but only a few vaccines have been tested in human volunteers to see if the vaccine could protect against HIV infection and/or AIDS. Two of these other vaccines had no effect and one had a very modest protective effect. None of these other vaccines was the same as the vaccines you will receive. A vaccine based on a vector made from a human adenovirus called HAdV-5 (also called Ad5) was tested in two studies (STEP and Phambili) in over 3000 men and women at risk for HIV in the Americas, Australia and South Africa. The HAdV-5 vector is a weakened form of a common cold virus. Vaccinations in both trials were stopped in 2007 because the vaccines did not prevent HIV infections and did not reduce the amount of HIV in the bloodstream of participants who became HIV-infected. In the STEP study, there were more HIV infections in vaccinated men than in the men who received Page 7 of 10
8 placebo. This was an unexpected result, which the trial had not been designed to detect. Men who already had antibody to HAdV-5 at the time of enrolment due to natural exposure to the adenovirus and were not circumcised showed more HIV infections; this was probably not due to chance. When the Phambili trial stopped vaccinations, there were more HIV infections in vaccinated women than in women who received placebo. This difference could have been due to chance, meaning that the vaccine was no different from placebo at protecting from HIV infection, because the trial was stopped very early. A different vaccine, also based on a vector made from HAdV-5, along with a DNA vaccine, has recently been tested in a large trial called HVTN 505 in the United States. This study enrolled about 2500 men who were at risk for HIV infection but did not have antibody to HAdV-5 and who were circumcised. In April 2013, the trial vaccinations were stopped because the vaccine did not protect against HIV infection and did not reduce the amount of HIV in the bloodstream of people became infected. There were slightly more HIV infections in the vaccine group compared to the placebo group. Statisticians determined that a difference of this size could occur by chance alone, meaning that this vaccine was not associated with increased risk of HIV infection. We are testing biologically different adenoviruses from HAdV-5, called AdCh3 and ChAdV63, isolated from chimpanzees. Antibodies to these viruses are very rare in people. Will the study benefit me? You will receive no direct benefit from this study. The aim of the study is to see whether co-vaccination against HIV and Hep C stimulates an immune response against both HIV-1 and Hep C, but you will not be protected against Hep C or HIV-1 infection, or AIDS. However, knowledge gained may in the future help others to avoid HIV-1 or Hep C infection. Can I take part in this study if I am pregnant? If you are trying to or planning to become pregnant, or if you are breast-feeding, you should not take part in this study. The safety of the vaccines in pregnancy is not known. You or your partner will be asked to use an effective method of contraception during the study, if this is appropriate and if you are not already doing so. Contraception will need to be continued for the duration of the study. If you become pregnant during the study, you should tell us immediately. Page 8 of 10
9 Will I be able to participate in other trials in the future if I have received this vaccine? This depends on the specific criteria of each trial and it would need to be discussed on an individual basis. If you decide not to take part or to withdraw from this study because you wish to ensure that you are eligible for another study, we will respect your decision. Will the information from the study be confidential? Yes, all your records will be kept confidential. In addition to the doctors and nurses that you meet, other trial staff involved who have access to your records are equally bound to respect your confidentiality. The data will be collected and kept in accordance with the Data Protection Act All data will be coded, which means that your name will not be used on any research report or samples collected during the study. Your identifiable information will be kept in a secure location separate to the anonymised data for the duration of the study. Authorised members of the University of Oxford may be given access to data for monitoring and/or audit of the study to ensure we are complying with the regulations. Anonymised data collected during the course of the study may be passed onto other organisations, which may include commercial organisations. What if new information becomes available? We will share any new information learned during the course of the study that might change your mind about staying in the study. Who reviews the study? The trial procedures have been reviewed and approved by the Research Ethics Committee (REC). The REC along with an independent committee of experts (Data Safety Monitoring Committee) will monitor the progress of the trial, playing close attention to events that could have an impact on the health of the participants. What happens to the results at the end of the study? One of the study doctors will inform you of the results of the trial. The data gathered from the research will be submitted for publication in scientific journals. In addition, we may produce reports for the general public which would be published via the web and other media. You will not be identified in any report or publication. Who sponsors the study? The study is sponsored by the University of Oxford. Page 9 of 10
10 Research-Related Injury We do not expect you to suffer any injury as a result of participating in this study. Medical care will be organised in the unlikely event that an injury related to the study does occur. The University of Oxford, as Sponsor, has appropriate insurance in place for the unlikely event that you suffer any harm as a direct consequence of your participation in this trial. Will I be paid for taking part in this study? You will receive between 40 to 60 per study visit to compensate you for your time and travel. If you participate in the study until the end, you will receive a total payment of 780. If you choose to leave the study early or are withdrawn from the study you will be compensated according to the length of your participation based on these figures. You should note that compensation payments received in the trial may have an impact on your entitlements to benefits. What happens if I have a complaint? 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 Chief Investigator, Lucy Dorrell, on Alternatively, you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on , or by at ctrg@admin.ox.ac.uk. Who can I contact for more information? For questions about this study please contact: vaccinetrials@ndm.ox.ac.uk, Tel.: Centre of Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital, Old Road, Headington, Oxford, OX3 7LE If you have any questions you would prefer to discuss with a staff member who is not directly involved in this research, please contact: Dr Brian Angus, Consultant Physician brian.angus@ndm.ox.ac.uk, Tel.: Nuffield Department of Clinical Medicine, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU Page 10 of 10
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