1. What is a vaccine study? A vaccine teaches the body to prevent a particular infection or fight a disease. In order to develop a vaccine, researchers need to test it in people. A vaccine study tests whether the vaccine is safe (does not cause health problems) and whether people s immune systems respond to the study vaccines. Your immune system protects you from disease. A vaccine study can also be used to find out if a vaccine might help prevent or fight an infection or disease. It takes many vaccine studies to produce a safe, effective vaccine. Currently there is no licensed vaccine against HIV or AIDS. 2. What is the HVTN 110 study? HVTN 110 tests 3 experimental vaccines against HIV. The study vaccines are called Ad4-mgag, Ad4- EnvC150, and AIDSVAX B/E. The Ad4-mgag and Ad4-EnvC150 vaccines are supplied by PaxVax, Inc. (San Diego, California, USA), and the AIDSVAX B/E vaccine is supplied by Global Solutions for Infectious Diseases (GSID) (South San Francisco, California, USA). The study vaccines used in this study are not made from live HIV, killed HIV, or HIV-infected human cells. They cannot cause HIV infection or AIDS. We can give you more detailed information about the study vaccines, if you would like. 3. What organizations are involved in this study? The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN) developed this study, along with the companies that are supplying the study vaccines, PaxVax, Inc (San Diego, CA) and Global Solutions for Infectious Diseases (San Francisco, CA). NIAID is part of the United States government. The HVTN is an international collaboration of scientists, educators, and community members searching for an effective and safe HIV vaccine. The HVTN is funded by NIAID. In Atlanta, the study is taking place at The Hope Clinic, which is part of the Emory Vaccine Center, of Emory University School of Medicine. 4. When and where will this study be done? The Hope Clinic The study is expected to begin enrolling participants around December, 2014. It will be done in these locations: Page 1 of 6 Version 1.0 Date: 11/25/2014
United States: Atlanta, GA; Birmingham, AL, Boston, MA; Cleveland, OH; Nashville, TN; New York, NY; Philadelphia, PA; Rochester, NY; San Francisco, CA; Seattle, WA. 5. Why is this study being done? All of the HVTN s studies work toward our mission to find a safe and effective HIV vaccine. The main purpose of this study is to see if the study vaccines are safe to give to people, and whether people are able to take the study vaccines without becoming too uncomfortable. Another important goal of the study is to test if people s immune systems respond to the study vaccines. We are also studying whether different ways of giving vaccines cause different immune responses in people. 6. What are the different ways of giving these vaccines? The Ad4-mgag and Ad4-EnvC150 vaccines or placebos are given as a set of pills that people will swallow. The placebo is a set of sugar pills with no vaccine. The AIDSVAX B/E vaccine (that everyone will get) will be given as an injection. 7. Are these study vaccines safe? We do not know all the risks of the study vaccines because they have not been given to people together before. The AIDSVAX B/E vaccine has been given to thousands of people as part of the RV144 HIV vaccine study in Thailand. The AIDSVAX B/E vaccine did not cause any serious health problems in those participants. The Ad4-mgag and Ad4- EnvC150 were given to about 5 people before. These vaccines are made with a virus called adenovirus subtype 4 (Ad4). Ad4 viruses have been used in studies for other vaccines (against anthrax and bird flu) and did not cause any serious health problems. Ad4 vaccines similar to those used in HVTN110 have been used for over 25 years in the military, and have been proven safe and effective in preventing Ad4-related disease in recruits. They have been given to more than 10 million people. 8. How many people will be in this study, and who can join? The study will involve up to 60 participants. To join this study, a person must be healthy, between 18 and 49 years old, and not infected with HIV. They cannot be pregnant or breastfeeding. We will ask people about their medical history, give them a physical exam and take blood and urine samples for testing. We will also ask people about their sexual activity and drug use. There are also other criteria that must be met, and for this study we will have several special requirements, which are described in Question 9. 9. What are the special requirements for this study? The Ad4 vaccines contain live, weakened adenovirus. Adenoviruses can cause symptoms of the common cold. It is possible that people who get the Ad4 vaccines may pass the Ad4 to other people with whom they have intimate contact, during the month after they receive the vaccine. An intimate contact is defined as someone who you kiss, have sexual intercourse with, or have oral sex with during the study. Adenoviruses can be spread by these kinds of intimate contact. We think it is unlikely that this would happen in this study, because the vaccines use a weakened form of Ad4. Page 2 of 6
In order to better understand how Ad4 is passed to others, your intimate contacts must also join the study. We will ask them to sign a similar consent form to the one participants will sign. We want to make sure they understand the potential risks to them. We will ask vaccine recipients not to have intimate contact with anyone for 28 days following each of the 3 Ad4 vaccinations. After 28 days there is no longer a risk of passing Ad4 to others. They must also tell the researchers if they have any new intimate contacts during the study. If their new intimate contacts do not want to join this study, they will not be able to get any more doses of the Ad4 vaccines, but can still get the AIDSVAX B/E injection. Since it is possible for the vaccine recipient to pass Ad4 to others, participants will not be allowed to join the study if they: live with or care for children under age 18 live with or care for people with weakened immune systems, including people with HIV live with or care for adults over age 65 have intimate contact with any members of the groups above Vaccine recipients will be provided with information sheets to share with the members of their household that describe how to prevent Ad4 infection. Ad4 can be passed to others in your saliva, nasal fluid, stools (feces). If any household members show symptoms of an Ad4 infection, they will be asked to come to the clinic to join the study and be seen by a clinician, but this is optional. 10. How is Ad4 different from the Ad5 that was used in previous vaccine studies? Though these 2 adenoviruses belong to the same family, they are different viruses and act differently in the body. Ad4 is also not as common as Ad5, and the body s responses to it may be different. In addition, studies involving 100,000 military recruits receiving Ad4 vaccines found no difference in HIV rates among vaccinees compared with 100,000 recruits who did not get the vaccines. This suggests that Ad4 by itself does not increase the risk of HIV infection. 11. Can these study vaccines protect participants from getting infected with HIV? Participants should not expect to be protected from HIV by these study vaccines. In fact, participants may not even get all the study vaccines in this study, since some participants will get a placebo instead of the Ad4 vaccines. This study is not designed to find out if the study vaccines work to prevent or fight HIV. More studies will need to be done to learn if they do. Because it is not expected that the study vaccines will prevent HIV, participants in this study will be counseled on how to avoid behavior that will put them at risk of HIV infection. 12. How long will it take to find out if the study vaccines work? The results of HVTN 110 will help researchers to know if they should do more studies on the vaccine(s). These additional studies would give the study vaccines to more people to see if it is/they Page 3 of 6
are safe. They would also give us a better understanding of how the immune system responds, and whether the vaccines can prevent HIV infection. If more studies are done, it could take several years to find out if the study vaccines work. Vaccine recipients will have 14 months of scheduled clinic visits (main study) followed by annual health contacts for a total of 3 years following initial study vaccination. Intimate contacts will be enrolled and monitored for adenovirus and HIV antibodies for up to 8 months. Household contacts showing symptoms of Ad4 infection will be followed for about 2 months, if they are willing. 13. How will the health and rights of participants be protected? Protecting the health and respecting the rights of participants are top priorities for everyone in the HVTN. Without volunteers, we would never be able to find an HIV vaccine. A first step in protecting the rights of study participants is to give them information about the study before they join. Clinic staff will give people information about the study products and procedures, the possible risks and benefits to participants, and the rights that they have. These include the right to receive any new information about the study that could affect whether they want to stay in it, and the right to leave the study at any time. During the study, the clinic staff will monitor participants and their intimate contacts to make sure the study vaccines are not causing any health problems. The clinic staff will also ask participants about any social problems they may experience from being in the study. If a participant or their intimate contact has a health or social problem related to being in the study, clinic staff will help them. Intimate and household contacts will be provided with information sheets describing how to avoid Ad4 infection. There are also several groups involved in protecting participants rights and well-being: A study safety review team and an independent safety monitoring board regularly look at the health information from the study to decide whether it appears safe to continue giving study injections. An Institutional Review Board (IRB) or Ethics Committee (EC) reviews and monitors the study plan for each clinic doing the study, including the information that is given to people about the study, study progress, and health problems in participants. The IRB/EC also looks at whether participant rights are being respected. The US Food & Drug Administration (FDA) also reviews the study. The FDA enforces US laws about research in humans and the use of study vaccines in research. Each study clinic has a Community Advisory Board (CAB). Its members are local people who bring the concerns and interests of the community and study participants to the researchers. CAB members are part of the team that develops each study. They also help develop or review the information that is given to participants. Page 4 of 6
The Hope Clinic (404) 712-1370 14. Could the study vaccines cause a positive result on an HIV test? Yes, the study vaccines may cause you to test positive on some types of HIV tests. If a participant gets an HIV study vaccine, their body may make antibodies to HIV. Antibodies help you fight infection. Standard HIV tests search for HIV antibodies as a sign of infection. Because of this, a person could have a positive HIV test result even if they are not infected with HIV. This is called a vaccine-induced seropositive (VISP) test result. You may also see this called Vaccine-Induced Seroreactive. We do not know who will have VISP test results or how long these test results may last. People with VISP test results need specific HIV tests to determine if a positive test result is due to VISP or a true infection. Clinics participating in this study have access to these specific tests that look for the virus itself instead of looking for antibodies. No health problems are associated with a VISP test result, but VISP test results may cause problems in several areas such as medical or dental care, employment, insurance, a visa for traveling, or entry into the military. You might not be allowed to donate blood or other organs. If you are planning to apply for insurance, employment, or the military inform your study site right away. The insurance company, employer, or military agency may not accept HIV test results from the HVTN. However, the HVTN can work with them to ensure the right test is done that will show your true HIV status. It is possible for intimate contacts to get VISP. There is a slight chance that household contacts will have VISP, but it is not expected. We will provide the same HIV testing for any contacts with VISP. 15. Where can I find more information? About HIV vaccine clinical studies: www.clinicaltrials.gov About the HIV Vaccine Trials Network: www.hvtn.org About VISP: http://www.hvtn.org/visp/index.html If you have additional questions that were not answered by this document, please ask us. You can contact: The Hope Clinic (404) 712-1370 Page 5 of 6
HVTN 110 Vaccine Study: Additional Vaccine Information Two of the study vaccines, called Ad4-mgag and Ad4- EnvC150, are made from a virus called adenovirus subtype 4. Adenoviruses are common, and most people have been previously infected with one of the many types of adenoviruses. These study vaccines are designed to tell the body to make proteins that are found in HIV. (Proteins are natural substances. They help build and maintain your body, and do the same for viruses such as HIV.) The body s immune system may respond to these proteins. This is called an immune response. An immune response prepares the body to recognize the same proteins in HIV and fight it if a person is exposed to HIV in the future. One of the study vaccines, AIDSVAX B/E, is made from a protein that is similar to a protein found in HIV. This can also produce an immune response. This vaccine is given with an adjuvant called alum. An adjuvant is a substance added to a vaccine to increase the immune response. Alum is used in many licensed vaccines. Some participants in this study will get a placebo instead of the Ad4 vaccines. The placebo is a set of sugar pills with no vaccine. Page 6 of 6 Version 1.0 Date: 11/25/2014