What makes
vaccine break-throughs possible?

Ending HIV is about all of us.

Understanding the science and how research studies work helps you know what important work there is to be done, and how you can participate.

Answers to your questions

Why it matters now

Over the last 40 years, HIV has taken millions of lives of loved ones around the world. And while there are effective treatments, there is still no cure. Nearly 35,000 people got HIV in the US last year alone. And 13% of those who have it, don’t even know it.

Throughout history, science has shown that vaccines are one of the most important tools to prevent infectious diseases. That’s why finding a safe and effective vaccine to prevent HIV is a priority. But we can’t do it without the help of volunteers.

Every day, thousands of people acquire HIV around the world. However, thanks to all these years of research and all the breakthroughs in COVID-19, we are closer to finding a vaccine to fight against HIV.

History has shown us that when it comes to a pandemic, no one is safe until everyone is safe. Now science needs more people,—just like you—to get involved to ensure that all kinds of people are represented in research.

Vaccine & Antibody Studies

A vaccine teaches the body to prevent a particular infection or fight a disease. In order to prove a vaccine is safe and effective, 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.

Vaccines are used to train our bodies’ immune systems to fight off bacteria and viruses that can cause disease. That response especially depends on two main parts of the immune system: antibodies and T-cells. Antibodies prevent infections, and T-cells help to clear out the infected cells if an infection does happen. A vaccine can teach antibodies and T-cells what HIV looks like, so that our bodies are prepared to fight back faster and stronger if we are ever exposed to HIV. The studies are done in phases, step by step, to look at safety and immune responses while protecting the well-being of the participants.

Most antibodies that our bodies make are specific to one particular bacteria or virus. HIV is challenging because it has many different strains that are found in different parts of the world, so building a global vaccine is tough. BnAbs are manufactured in a laboratory, and are copies of naturally occurring antibodies. BnAbs are special because they can block many different HIV strains. Many new bnAbs have been discovered in the past few years, and studies are looking at them individually and in combinations.

Antibodies work to block infection, so it is impossible for the bnAbs used in a study to cause an HIV infection.

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 chickenpox. Some of the antibodies that are used for preventing infections are made in laboratories. Manufactured bnAbs have been used successfully to prevent a dangerous respiratory infection in infants called Respiratory Syncytial Virus (RSV), and the AMP Studies showed that they have value in blocking HIV as well.

Like vaccine studies, bnAb studies are done step by step to answer questions about safety, how the body responds, and how the bnAbs move around in the body while protecting the well-being of participants.

In traditional research, people get a vaccine and scientists wait to see if their bodies will respond by making antibodies against HIV. In bnAb studies, we skip a step and give people the antibodies directly. We use intravenous infusions (commonly known as “giving an IV”) or in some cases, with traditional shots in a muscle or under the skin. Another difference is that antibodies produced naturally by your body in response to a vaccine can last for a long time, but these laboratory-made bnAbs usually only last for a few months, so people need to get them on a regular schedule.

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 suggest that it is safe to do so. However, results in animals do not always predict the results in people. That is why the main purpose of Phase 1 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. 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. it is not until Phase 2b or Phase 3, where thousands of people are enrolled, that we look at whether the product is successful in preventing infection. 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.

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 effective HIV prevention methods. A first step in protecting the rights of study participants is to give them information about the study before they join through a process called Informed Consent. 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 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. Similar regulatory agencies in each country where a study is being conducted will also review. — 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 types of HIV tests to determine if a positive test result is due to VISP or a true infection. Clinics participating in HVTN studies have access to these specific tests that look for the virus itself instead of looking for antibodies. These tests are available to study participants without any charge, even after their study participation is complete. 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.

We are currently looking for people to participate in studies of preventive HIV vaccines and broadly neutralizing antibodies. If you join our Red Ribbon Registry, a site located near you will be able to contact you if they think you would be eligible for a study they have available.

In general, study participants must be:
18-50 years old HIV-negative In overall good health Living near one of our clinic sites

If you prefer to talk with someone directly, we can put you in touch with a study clinic in or near your city.
The clinic staff are the best people to tell you about the studies being done in your area. They will be able to answer your questions, and they love talking to people about the studies! You are under no obligation after finding out more information or asking questions. Email [email protected] with your location and we’ll be in touch.

Most studies require coming into the clinic for 10 or more visits over 1-2 years. If you go through an informed consent process to join a study, you will be given the specific details for that study.

No! 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. Our goal is to find ways to prevent HIV.

Study volunteers are reimbursed for their time, travel and the inconvenience of study participation. If you go through an informed consent process to join a study, you will be given the specific details for that study.

Some vaccines are being tested in people for the first time, while others may have been tested in previous studies. When you go through the informed consent process, you will be told everything that is known about the products, including the results from previous studies.

Eligibility

No. The HVTN and HPTN are doing studies for HIV prevention, so we enroll people who are not living with HIV.

Eligibility can usually be determined within a few days to a week through one or two visits to the study clinic. Some tests may take a little longer.

Most HVTN studies enroll adults aged 18 to 50, but there is some variation.

Maybe. Some medical conditions can prevent your participation, and it varies from study to study.

Maybe. The study staff will evaluate you to see if you are eligible to participate.

Probably not. Most HVTN studies do not enroll people who are pregnant, and pregnancy testing is done prior to each vaccination. This is because we don’t know about the safety risks to the fetus. We also counsel participants who are able to become pregnant about use of contraception during the study.

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