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. Some vaccine studies test 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. Some vaccine studies 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 705/HPX2008 study?
HVTN 705/HPX2008 tests 2 experimental vaccines against HIV. The study vaccines are called Ad26.Mos4.HIV and Clade C gp140. These vaccines were developed by Janssen Vaccines & Prevention B.V. From here on, we will call them Ad26 and Protein or study vaccines.
The Ad26 vaccine
The Ad26 vaccine is made from a virus called Adenovirus type 26. This vaccine has parts of HIV inserted. It is designed to tell the body to make proteins that are similar to proteins found in HIV. (Proteins are natural substances that are found in all living things, such as the human body and viruses such as HIV.) The body’s immune system may respond to the copies of HIV proteins in the study vaccine. This is called an immune response. An immune response prepares the body to recognize the same proteins in HIV and fight the virus if a person is exposed to HIV in the future. Adenovirus type 26 is common in everyday life and can cause colds and respiratory infections. However, the adenovirus used in this study vaccine has been weakened so it cannot cause infection and is harmless to humans.
The Protein vaccine
The Protein vaccine, Clade C gp140, is made from a protein that is similar to a protein found on the surface of HIV. This can also produce an immune response.
The Protein vaccine in the study is mixed with an adjuvant called Aluminum Phosphate. An adjuvant is a substance added to a vaccine to increase the immune response. Aluminum is used in many common vaccines such as those for Hepatitis A and B, diphtheria, and tetanus.
The products used in this study are not made from live HIV, killed HIV, or HIV-infected human cells. These study vaccines 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), the HIV Vaccine Trials Network (HVTN) and Janssen Vaccines & Prevention B.V. developed this study. Janssen Vaccines & Prevention B.V. is the regulatory sponsor and is also supplying the study vaccines. NIAID is part of the National Institutes of Health (NIH), which 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 and this particular study is co-funded by the Bill & Melinda Gates Foundation and Janssen Vaccines & Prevention B.V
4. When and where will this study be done?
The study is expected to begin enrolling participants around October 2017. It will be done in these locations:
- Malawi: Lilongwe
- Mozambique: Maputo
- South Africa: Bloemfontein, Brits, Cape Town (Emavundleni, Khayelitsha, and Masiphumelele), Durban (Chatsworth, eThekwini, Isipingo, Tongaat and Verulam), Elansdoorn, Klerksdorp, Ladysmith, Mamelodi, Medunsa, Mthatha, Rustenburg, Soshanguve, Soweto (Bara and Kliptown), and Tembisa
- Zambia: Lusaka and Ndola
- Zimbabwe: Harare
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 purposes of the study are:
- To test whether the study vaccines can prevent HIV infection
- To provide more information about the safety of the study vaccines
- To give us clues about how a vaccine might work to prevent HIV infection
6. How many people will be in this study, and who can join?
The study will involve about 2600 female participants.
To join this study, women must be healthy, between 18 and 35 years old, and not infected with HIV. They cannot be pregnant or breastfeeding. There are also other criteria that must be met. We will ask women about their medical history, give them a physical exam and take blood and urine samples for testing. We will also ask women about their sexual activity and drug use.
7. Are these study vaccines safe?
We do not know all the risks of the study vaccines because they have only been given to a limited number of people before. The Protein vaccine has been given to about 300 people and the Ad26 vaccine has been given to about 110 people. Although no one in the earlier studies had any serious health problems related to these study vaccines, there is always the possibility that there could be problems no one expected. That is why one purpose of this study is to test whether the vaccines are safe when given to more people. Each participant’s health will be watched closely by trained nurses and doctors throughout the study.
8. 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 the study vaccines in this study, since half of participants will get a placebo. The placebo in this study is sterile salt water.
This study is designed to find out if the study vaccines work to prevent or fight HIV.
Because we don’t know if the study vaccines will prevent HIV/AIDS, participants in this study will be counseled on how to avoid HIV infection and will be referred to facilities where they can access available HIV prevention methods.
9. How long will it take to find out if the study vaccines work?
We expect to learn if the study vaccines are preventing HIV infections in about 4 years. It is possible that we may know sooner.
10. 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 and Janssen Vaccines. 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 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 has a health or social problem related to being in the study, clinic staff will help them.
There are also several groups involved in protecting participants’ rights and well-being:
- A study safety review team and an independent data 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 South Africa Medicines Control Council, as well as national regulatory authorities of other countries, oversee the conduct of the study and require regular reports on the safety of participants.
- 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 clinic has an Institutional Biosafety Committee (IBC) that oversees how the study vaccines are prepared in the pharmacy and how they are used in the clinic.
- Some clinics have special Ethics Committees that oversee places where blood and other samples are stored. These places are called bio-banks or repositories.
- The South Africa Department of Agriculture, Forestry, and Fisheries (DAFF) has a special board that must review and approve all applications to import genetically modified materials (GMO) such as the Ad26 vaccine in this study.
- 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.
11. Could the study vaccines cause a positive result on an HIV test?
Yes, the study vaccines are likely to cause participants 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 people 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 Seroreactivity (VISR). 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. Trial participants should only be tested at clinics participating in this study.
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. People might not be allowed to donate blood or other organs. If participants are planning to apply for insurance, employment, or the military, they should inform the 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 a person’s true HIV status. If you have these antibodies and then fall pregnant they may be passed on to the baby, who may also be misdiagnosed as infected and put on treatment. The research clinic can give a copy of your results to you to use in any of these settings if you need this.