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 after it has been shown to be safe in animals. 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. It takes many vaccine studies to produce a safe, effective vaccine.

Currently there is no licensed vaccine against HIV or AIDS.

The vaccines being tested are not made from live HIV, killed HIV, or HIV-infected human cells. They cannot cause HIV infection or AIDS.

Antibodies are one of the natural ways that our bodies fight infection. Giving people antibodies to prevent an infection is an accepted medical practice that is more than 100 years old. For example, doctors give people natural antibodies to prevent infections like hepatitis A and B and chicken pox. Some of the antibodies that are used for preventing infections are made in laboratories. Manufactured antibodies have been used successfully to prevent a dangerous respiratory infection in infants called Respiratory Syncytial Virus (RSV).

Laboratory tests have shown that bnAbs can protect cells from being infected by the many different strains of HIV found around the world. They have also prevented animals from getting infected.

The bnAbs being tested are not made from live HIV, killed HIV, or HIV-infected human cells. They cannot cause HIV infection or AIDS. The antibodies are made in a laboratory, using the same kinds of processes used to make other medicines.

Although we have been doing this research since 1987, today is an exciting time for HIV science! The HVTN has more studies open now than ever before. There was also a study done in Thailand where the 2-vaccine combination reduced new infections by 32%, so that has given us lots of new information to follow up on. We need more people to volunteer for studies so we can keep pushing forward and make even more progress.

The HVTN and the HPTN are international collaborations of scientists, educators, and community members searching for effective and safe HIV prevention modalities and an HIV vaccine. The National Institute of Allergy and Infectious Diseases (NIAID) and the Networks developed these studies, along with scientists from the companies who developed and manufactured the specific study products. NIAID is part of the National Institutes of Health (NIH), which is part of the United States government. The HVTN and HPTN are primarily funded by NIAID. Another significant funding source is the Bill & Melinda Gates Foundation. In addition, each of our study clinics is based at a local organization such as a university, hospital, or health department.

To learn more about the HPTN and their other prevention studies (including other long-acting options), visit www.hptn.org.

All of the HVTN’s and HPTN’s studies work toward our missions to prevent HIV transmission and infection, and to find a safe and effective HIV vaccine. The main purpose of these studies is to test for safety, and whether people are able to take the study products without becoming too uncomfortable. Another important goal of the studies is to test if people’s immune systems respond to the study products. Studies of bnAbs might lead to new ways to prevent HIV themselves, and they also inform the development of HIV vaccines by helping us understand the response the immune system must produce to prevent HIV.

Globally, there are still about 5,000 new HIV infections every day, which is about 1.8 million a year. In the US, there are over 37,000 new HIV infections every year. Over 24,000 of those infections happen among people age 20-40. Gay and bisexual men are still the most heavily impacted group, particularly African American and Latino young men, but infections among women, heterosexual people, and people who use drugs also continue to impact people every day. Throughout history, vaccines and clean water have been the two most important tools to end infectious diseases, and we hope you will consider joining us in the search for new HIV prevention tools and a vaccine.

We do not know all the risks of the study vaccines and bnAbs. Some are being tested in people for the first time, while with others we have more information and experience. Some adjuvants (products added to vaccines to get a stronger response) are also experimental. We do not move forward with studies in people until results from studies of the products in animals show no safety concerns. However, results in animals do not always predict the results in people. That is why the main purpose of these studies is to test whether the study vaccines or bnAbs are safe to give to people. Each participant’s health will be watched closely throughout the study. If you are interested in joining a study, we will review all of the information we know about the specific products being used in that study during the informed consent process.

The products used in these studies are not made from live HIV, killed HIV, or HIV-infected human cells. These study products cannot cause HIV infection or AIDS.

Participants should not expect to be protected from HIV by these study vaccines or bnAbs. In fact, participants may not even get the study vaccines or bnAbs in the study, since some participants might get a placebo.

These early stage studies are not designed to find out if the products work to prevent HIV infection. More studies will need to be done to learn if they do.

Because it is not expected that the study products will prevent HIV/AIDS, participants will be counseled on how to reduce their risk of HIV infection.

These early stage studies will help researchers determine which products are worthy of further study. It may take several rounds of additional studies over a number of years to fully determine the safety of a product, how the immune system responds, and ultimately whether a product is effective and practical. This research process from the time a research product (such as a bnAb or vaccine) first gets tested in people to proving that it works to prevent infection could take a decade or more.

Protecting the health and respecting the rights of participants are top priorities for everyone in the HVTN and HPTN. Without volunteers, we would never be able to find effective prevention methods or 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 or bnAbs 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 safety monitoring board regularly look at the health information from the study to decide whether it appears safe to continue giving study injections or IV infusions.
• 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 and bnAbs 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.
• The HVTN and HPTN have a policy that outlines the rights and responsibilities of study participants. It is given to every person during the informed consent process.

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 actually infected with HIV. This is called a vaccine-induced seropositive (VISP) test result. 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 these studies 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, tell your study clinic 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.

About HIV vaccine and bnAb clinical studies: www.clinicaltrials.gov

About the HIV Vaccine Trials Network: www.hvtn.org

About the HIV Prevention Trials Network: www.hptn.org

About your rights and responsibilities as a study participant: http://www.hvtn.org/en/participants/participants-rights.html

If you have additional questions that were not answered, please email us at [email protected] or contact the study clinic near you.