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N Engl J Med 2Partnership for Research on Ebola VACcination (PREVAC) CONSENT TO PARTICIPATE IN STUDY Coordinating Investigator: Yazdan Yazdanpanah, Institut National de la Santé et de la Recherche Médicale (INSERM), France Country Principal Investigators (PIs): Abdoul Habib Beavogui, Guinea Mark Kieh, Liberia Stephen B. Kennedy (Co-PI), Liberia Moses B. F. Massaquoi (Co-PI), Liberia Fatorma K. Bolay (Co-PI), Liberia Bailah Leigh, Sierra Leone Seydou Doumbia, Mali (UCRC) Samba Sow, Mali (CVD) Milagritos D. Tapia, Mali (CVD co-investigator) Sponsors: INSERM, France National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), United States London School of Hygiene & Tropical Medicine (LSHTM), Great Britain Sites: Liberia, West Africa Guinea, West Africa Sierra Leone, West Africa Mali, West Africa WHAT IS A VACCINE CLINICAL RESEARCH STUDY? Vaccines are medicines that are used to prevent people from getting certain diseases. Many people get vaccines to prevent diseases like flu, measles, polio, and tetanus. A vaccine helps your body to fight off a particular germ if you come in contact with it. A clinical research study helps doctors understand new ways to prevent or treat a disease. One way to do this is by studying vaccines. In a study, the vaccines are PREVAC Version 4 Page 2 of 9 ‘experimental,’ which means they are still being studied. That is why studies are needed to find out if vaccines are safe and work in people. WHAT IS THIS STUDY ABOUT? You are here today to hear about a vaccine clinical research study that we are inviting you to participate in. Right now, there are no approved vaccines to stop people from getting sick with Ebola. In this study, we will test 3 experimental vaccines to see if they are safe and if they can get the body to make antibodies against Ebola. Antibodies are what the body makes to fight off infection. In the rest of this consent document, ‘you’ can mean you or your child if you are thinking about allowing your child to be in the study. WHAT VACCINES ARE BEING STUDIED? We are studying 3 different kinds of vaccines (rVSV∆G-ZEBOV, Ad26.ZEBOV, and MVA-BN-Filo) used in different combinations. Each participant will receive 1 injection followed by another injection 56 days later. Each of the vaccines has a very small portion of the Ebola virus. But you cannot get Ebola from the vaccines. These vaccines have been given to many adults and some children around the world. Some people on this study will get placebo and others will get 1 or 2 of the vaccines. The placebo is an injection of salt water, which contains no vaccine and has no effect on the body. This is done to find out how well the vaccines work. If there is an Ebola outbreak in the area where the study is being conducted, participants that are within the “ring of contacts” identified by local health officials may be offered the opportunity to receive the rVSVΔG-ZEBOV vaccine. WILL I GET A VACCINE OR SALT WATER? There are 5 study groups. If you join the study, you will be randomly put into 1 of these groups. This happens by chance. Out of every 7 people on this study, 5 will be in a vaccine group and 2 will be in a salt water group. You and the study staff will not know what group you are in or if you are getting vaccine or salt water. This is done to prevent study participants and the study staff from forming opinions about the study drugs that could affect the outcome of the study. YOU CAN SAY “YES” OR “NO” TO TAKE PART IN THIS STUDY. To be in this study, you must be older than one year of age and plan to continue to live in the study area for at least the next year and are willing to follow the protocol requirements needed to take part in this study. The decision on when children will be enrolled will be made by an independent data and safety monitoring board. You cannot be in this study if you are an Ebola survivor or if you have ever received an PREVAC Version 4 Page 3 of 9 Ebola vaccine. Pregnant women and breastfeeding mothers are not allowed to take part in the study. Additionally, children will have laboratory tests done to determine if they have HIV. Children who are HIV positive will not be able to take part in this study. If you think you may want to join this study, we will describe the study and answer any questions you may have. You can also talk to your friends and family about the study. We will also give you written information about the study. You do not have to join this study if you don’t want to. If you agree to be in the study, we will ask you to sign this consent form. WHAT HAPPENS IF I AGREE TO BE IN THIS