Dr Angela M. Minassian E-mail: [email protected] Tel: +44 1865 611424 (volunteer co-ordinator) IRAS project ID: 261722 NRES Committee South Central Oxford A CCVTM, Churchill Hospital, Old Road, Headington Reference number: 19/SC/0322 Oxford, OX3 7LE PARTICIPANT INFORMATION SHEET: VAC077 A study to assess safety and immunogenicity of the Pfs25- IMX313/Matrix-M1 vaccine A Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK We would like to invite you to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it would involve. Please take time to read the following information carefully and discuss it with friends, relatives and your General Practitioner (GP) if you wish. Part 1 tells you the purpose of the study and what will happen to you if you take part. Part 2 tells you more information about the conduct of the study. Please ask us if there is anything that is not clear, or if you would like more information. You will be able to discuss the trial with us if you attend a screening visit, and we’re happy to answer queries before this too. Take time to decide whether or not to take part. Part 1 Why are we conducting this study? Malaria is a major global health problem. It is a potentially fatal disease caused by a parasite, which is transmitted to people by mosquitoes. Each year there are more than 200 million cases and over 400,000 deaths worldwide, most of which (61%) occur in children under 5 years old. There is a great need for new ways to reduce the spread of malaria by mosquitoes. Pfs25-IMX313/Matrix-M1 is a new ‘transmission-blocking vaccine’ for malaria. The vaccine aims to cause the body to produce an immune response which blocks the malaria parasite developing in the mosquito, so that when the mosquito next bites, it cannot infect another person with malaria. This means that unlike other vaccines, Pfs25-IMX313/Matrix-M1 does not aim to protect the person being vaccinated from disease but instead to reduce risk of infection to other people. In this way, if effective, a transmission-blocking vaccine could stop onward transmission of malaria and bring down the number of cases in the whole population. In this study, the Pfs25-IMX313/Matrix-M1 vaccine will be given to people for the first time. The purpose of this study is to assess the safety of Pfs25-IMX313/Matrix-M1, as well as the body’s immune response to the vaccine. We will do this by giving volunteers three doses of the vaccine, at four week intervals, doing blood tests and collecting information about any symptoms that occur after vaccination. We plan to recruit a total of 8 volunteers to be vaccinated. VAC077 Participant Information Sheet, V 2.0, 14th June 2019, University of Oxford. What will happen if I decide to take part? This study involves having three doses of the Pfs25-IMX313/Matrix-M1 vaccine and then being followed up with regular clinic visits and blood tests at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) clinic in Oxford. You will also be asked to complete a diary, recording any symptoms you experience after each vaccination. Do I have to take part? No. It is up to you to decide whether or not to take part. Your decision not to take part will not result in any penalty, or loss of benefits to which you are otherwise entitled. Even after consenting to take part you are free to withdraw at any time without giving a reason, but you may be asked to return to the clinic for follow up for safety reasons. The University of Oxford does not urge, influence, or encourage any employees/students of the institution to take part in this research study. Your decision to not participate in the study, or a decision on your part to withdraw from the study, will have no effect whatsoever on your employment/student status at the University. Length of research If you decide to take part in this study, you will be involved in the trial for approximately 8 months. In addition to the above, we would like to highlight the following key points we think you should consider before making a decision: This is the first time this vaccine is being tested in humans The Pfs25-IMX313 vaccine is being given to humans for the first time in this study, therefore, we not yet know the effects of the vaccine. The adjuvant that will be given together with the vaccine, called Matrix-M, has however been administered with other vaccines in previous clinical trials and has been shown to be well tolerated. We expect side effects of the vaccine will be similar to those seen in these previous studies using the same adjuvant, but as this is the first trial to test Pfs25- IMX313/Matrix-M1 vaccine, there is a chance that the effects may be different, or more severe. Following each vaccination, volunteers are required to attend regular clinic follow-ups and complete a daily diary The vaccine schedule involves three vaccinations, given at approximately 4 week intervals. Following each vaccination, volunteers will be required to fill in an electronic diary every day for 28 days and attend the clinic on days 1, 7, 14 and 28 after each vaccine. In addition, there are 2 further clinic visits after the last dose. Overall, volunteers will be followed for approximately 8 months. Each clinic visit involves blood tests to assess safety of the vaccine and the body’s immune response Blood tests will be taken at each clinic visit to help us assess any side effects of the vaccine and how the body’s immune system is responding. The volume of blood taken varies between 10 to 128 ml per visit (equivalent to 1-9 tablespoons), with approximately 972mL taken over the course of the study in total. Due to these regular blood tests, volunteers will be required to refrain from blood donation for the duration of the trial, as donating blood could increase the risk of anaemia. All volunteers are at risk of developing malaria following vaccination This vaccine is designed to prevent onward transmission of malaria, therefore all volunteers will remain at risk of malaria infection themselves. Therefore, in the future, before travelling to an area where malaria is present, volunteers should always seek and follow health advice about malaria prevention. VAC077 Participant Information Sheet, V 2.0, 14th June 2019, University of Oxford. CONSIDERATIONS BEFORE TAKING PART IN THIS STUDY Am I eligible to be involved in the trial? In order to be involved in the study you must: Be a healthy adult aged between 18 and 45 years. Be able and willing (in the Investigator’s opinion) to comply with all study requirements. Allow the Investigators to discuss your medical history with your GP. Practice continuous effective contraception for the duration of the study (women only). Refrain from blood donation during the course of the study. You cannot participate in this study if: You have had malaria before. You have travelled to a malaria endemic region in the last 6 months or are intending to travel to a malaria endemic region during the time you would be involved in the study. You have participated in another research study in the last 30 days. You are planning to participate in another study at the same time as this study. You have previously received an investigational vaccine likely to impact on interpretation of the trial data. You have had immunoglobulins and/or any blood products (such as a blood transfusion) in the 3 months preceding your involvement this trial. You have problems with your immune system. You are pregnant, breast feeding or intend to become pregnant during the study You are allergic to eggs You have a history of allergic disease or reactions to any component of the vaccine You have a history of a severe allergic reaction to a vaccination. You have a history of cancer. You have a history of a serious psychiatric condition that may affect participation in the study. You have any other serious long-term illnesses requiring hospital follow-up. You drink on average more than 25 units of alcohol a week (a pint of beer is 2 - 3 units, a small glass of wine (125mL) 1 unit and a shot of spirits (25mL) one unit). You have injected illegal drugs at any time in the last 5 years. You have hepatitis B, hepatitis C or HIV infection. Mild conditions, such as childhood asthma, which are well-controlled, would not automatically exclude you from participating. If you are unclear whether you are eligible to be involved in the study you can contact the study team who will be able to advise you. Screening Visit: This takes place at The Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) at The Churchill Hospital, Oxford and will last approximately two hours. The purpose of the screening visit is VAC077 Participant Information Sheet, V 2.0, 14th June 2019, University of Oxford. for you to discuss the trial with us and decide if you wish to enter the study. If you decide to participate, you will be asked to sign a consent form and we will check that you are eligible to participate. After signing the consent form: You will be asked some medical questions A doctor will examine you Blood samples and a urine sample will be taken.