1. What is a vaccine study?
A vaccine teaches the body’s immune system to prevent a particular infection or fight a specific disease. Your immune system protects you from disease. To develop a vaccine, researchers need to test it in people. A vaccine study tests whether study vaccines are safe (do not cause health problems) and whether people’s immune systems respond to the study vaccines. A vaccine study can also be used to find out if vaccines prevent or fight a target infection or disease. It takes many vaccine studies to produce a safe, effective vaccine.
Currently no vaccine against HIV or AIDS is licensed for use anywhere in the world.
2. What is the HVTN 702 study?
HVTN 702 tests a combination of two experimental vaccines against HIV. The study vaccines are called ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59. These vaccines are supplied by Sanofi Pasteur and GlaxoSmithKline (GSK), respectively.
We can give you more detailed information about the study vaccines, if you would like.
Half of the participants in this study will get a placebo instead of the study vaccines. A placebo is an injection without any study vaccine in it. In this study, the placebo is sterile salt water.
3. Is actual HIV used in the study vaccines?
No! Real HIV is NOT used to make the vaccines used in this study.
Vaccines for other diseases may be made from weakened forms of the germ causing the disease. However this approach is NOT used in making HIV vaccines. The vaccines used in this study are not made from either live HIV, killed HIV, parts taken from HIV, or HIV-infected human cells. They are made from materials designed to look like small parts of HIV to the immune system. Study vaccines cannot cause HIV infection or AIDS.
4. What are the vaccines being used in this study?
One of the study vaccines, ALVAC vCP2438, is made from a virus called canarypox. The study vaccine is designed to tell the body to make proteins that look like those 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 the virus if a person is exposed to HIV in the future.
The other vaccine, Bivalent Subtype C gp120, is made from two proteins that look like proteins found in HIV. This can also produce an immune response.
The Bivalent Subtype C gp120 vaccine is given with an adjuvant. An adjuvant is a substance added to a vaccine to increase the immune response. The adjuvant is called MF59. This adjuvant is used in commercially available vaccines (e.g., Fluad® seasonal flu vaccine) to increase the immune response in older people and infants. More than 100 million doses of vaccines with MF59 have been distributed worldwide.
5. What organizations are involved in this study?
The National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN) developed this study, along with the companies that are supplying the study vaccines, Sanofi Pasteur and GSK. NIAID is part of the National Institutes of Health (NIH), which is part of the United States government. Support for this study is also being provided by the South African Medical Research Council (SAMRC).
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.
Support for development of these vaccines and for the HVTN 702 clinical trial is also provided by the Bill & Melinda Gates Foundation.
6. When and where will this study be done?
The study began enrolling participants on October 26, 2016. It is being done in South Africa in these locations: Brits, Cape Town (Emavundleni and Khayelitsha), Durban (eThekwini, Isipingo, and Verulam), Klerksdorp, Ladysmith, Ga-Rankuwa, Mthatha, Rustenburg, Soshanguve, Soweto (Bara and Kliptown), and Tembisa.
7. 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, and
- To evaluate whether it is possible to license these vaccines for sale in South Africa.
8. How many people will be in this study, and who can join?
The study will involve about 5400 participants.
To join this study, a person 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 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.
9. Are these study vaccines safe?
These same study vaccines were given to 210 people in South Africa in a study called HVTN 100. Very similar vaccines have were given to more than 8000 people in a clinical trial called RV144 in Thailand and in clinical trials in the United States, France, South America, and the Caribbean. There have been no serious health problems related to these vaccines. However, there is always the possibility of problems that have not been seen yet. 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 throughout the study.
The vaccines in RV144 did not include MF59, which is used in one of the vaccines in this study. MF59 is an adjuvant, a substance that makes the immune system respond more strongly to a vaccine. MF59 is used with flu vaccines which are given to people in many countries every year.
The vaccines used in this study are not made from live HIV, killed HIV, parts taken from HIV, or HIV-infected human cells. These study vaccines cannot cause HIV infection or AIDS.
10. Can these study vaccines protect participants from getting infected with HIV?
Participants should not assume these study vaccines will protect them from HIV. In fact, participants may not even get the study vaccines in this study, since half of the participants will get placebos.
This study is being done to find out if the study vaccines can prevent HIV. If they do, more studies may be needed to confirm this.
Because we don’t know if the study vaccines will prevent HIV/AIDS, participants will be counseled on how to avoid HIV infection and will be referred to facilities where they can access available HIV prevention methods.
11. 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 5 years. It is possible that we may know sooner.
12. How will the safety, 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 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 and Safety Monitoring Board (DSMB) regularly look at the health information from the study to decide whether it seems safe and worthwhile to carry on with the study.
- 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 monitors safety of participants and looks at whether participant rights are being respected.
- The South Africa Medicines Control Council oversees the conduct of the study and requires regular reports on the safety of the participants.
- 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). That includes one of the vaccines 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.
- Participants are also counselled on the optimal ways to prevent HIV infection.
13. Could the study vaccines cause a positive result on an HIV test?
Yes, the study vaccines may cause a participant 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 medical or dental care, certain jobs, insurance, or a visa for work in or travel to certain countries. People with VISP test results might not be allowed to donate blood or other organs. People who are interested in joining the study and who are planning to apply for insurance or employment should talk to a study site about this right away. The insurance company or employer 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.
14. Where can I find more information?
About HIV vaccine clinical studies: www.clinicaltrials.gov
About the HIV Vaccine Trials Network: www.hvtn.org
If you have additional questions that were not answered by this document, please ask us. You can contact: [email protected]