STUDY? When you sign your name or put your mark on the consent form, it means that you agree to be in the study. You can change your mind at any time and leave the study. If you decide not to join the study or to leave the study later, you will not lose any regular health care services you already are getting. About 5,000 people will be taking part in this study in West Africa. We will ask you some questions and take your temperature to see if you qualify to be in this study. It is important for you to tell the truth so the study team can make sure it is safe for you to be in the study. WHAT DOES THE STUDY INVOLVE? If you qualify for the study and decide to join, you will come back to the clinic 8 or 9 times over the next year. After the first year, we may ask you to come back for 1 study visit once a year, for 4 more years. During the clinic visits, we will ask how you are feeling and if you have been sick, take your temperature and weight, and check your blood for research purposes. You will receive an inconvenience allowance for your time after each study visit at the site. During 2 of the clinic visits you will get an injection into your upper arm, or thigh for younger children. This injection will be a study vaccine or salt water. Getting the injection might hurt a little. You will feel a pinch with the needle. We will watch you closely for 30 minutes after the injection. We will give you an ID card with a phone number of who to contact in case you feel sick at any time after your visit. For children, we will contact you every day for 7 days after each injection to find out how you are doing. We will collect a saliva sample from a small group of children (up to 17 years old) during 7 of the clinic visits. We will collect the saliva by asking the child to spit into a cup. We will store the samples for research testing. They will be labeled with a code and not with a name. PREVAC Version 4 Page 4 of 9 WHAT COULD BE THE SIDE EFFECTS FROM THE INJECTIONS? These vaccines have been given to people in other research studies, and some of these people had side effects. Some of the side effects you may have after the injections are: • you may have pain, swelling, itchiness, redness, or warmth where you got the shot, and you may have a small sore on your arm just like any other vaccine; • your arm may be sore and harder to move; • the glands under your arms or in your neck may swell; • you may get a fever or headache, feel tired, or have chills, rash, nausea, change in appetite, vomiting, diarrhea, dizziness, muscle, joint or belly aches, mouth sores, or body pains. Some people will have some side effects after the injection. One person experienced itchiness across the body several days after vaccination. Other people may have no side effects. These side effects are temporary and should only last a few days but may last for a few weeks for some people. ARE THERE ANY OTHER RISKS OF VACCINATION? The immune system is the part of your body that fights infections. Vaccines work by getting the immune system ready to do this. Rarely, a vaccine can cause the immune system to attack parts of your own body. This type of side effect can sometimes be serious. People can have allergic reactions to vaccines, including hives, trouble breathing, or other allergic responses. This is very rare, but is also a possible effect of any vaccine. Vaccines may cause temporary changes in some blood test results. Some people have had mild tingling of the hands and feet or mild muscle weakness after vaccination. These have lasted as little as one day in some people and up to several weeks in other people, but usually go away on their own. One person developed a moderately severe case of these symptoms that has been ongoing for several months. These symptoms interfere with some of their daily activities. There may be other side effects of vaccination that may be severe or life-threatening. Recently, one person in a study of one of the MVA-BN-Filo vaccines had double vision, pain when moving the eye, and difficulty keeping balance when walking. This happened about a week after a common cold with fever and a month after vaccination. We do not know if the person received MVA-BN-Filo or placebo at their vaccination. This person had to go to the hospital for therapy and has recovered. These symptoms were most likely caused by the cold with fever. However, we cannot say for sure that this was not related to the vaccination. The risk of this happening in this study is not known, but is very low. A recent study of the rVSV∆G-ZEBOV vaccine was suspended after 3 of 9 volunteers reported signs of knee arthritis (with pain and stiffness) of unknown origin. The reason for this is not known. This effect was also seen in an earlier study of the vaccine in Europe. During the course of the study, whatever the trial product used, PREVAC Version 4 Page 5 of 9 the medical team will pay close attention to signs that may suggest arthritis. Since these are new vaccines, they may cause other changes that could hurt or bother you that we do not know about. Short-term medical care can be provided if there are side effects from the injections. It is important that you always tell the study staff if you have any problems and always keep in touch with them. WHAT INSTRUCTIONS DO I NEED TO FOLLOW? One of the study vaccines is made from the VSV virus, which normally affects animals and does not normally cause any serious disease in humans. This virus can be