At this time, all our vaccine studies are sponsored by the HIV Vaccine Trials Network (link to www.hvtn.org). The HVTN is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services (DHHS). The Network and NIAID have a close, cooperative working relationship, with shared attention to the intellectual and scientific issues. The Network’s headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
The HVTN partners with vaccine developers, public and private, to test promising vaccine candidates. The HIV Research Section in the San Francisco Department of Public Health is one of 27 partner sites around the world where the vaccine studies are conducted.
Many studies of HIV vaccines have been completed, thanks to the help of thousands of volunteers world-wide. Five of those studies were efficacy trials, testing to see whether the vaccine protected against HIV/AIDS.
In September, 2009, very exciting results were released from a large study in Thailand which showed that people who received the vaccine had 31% fewer HIV infections than those who receive placebo. Though this is a modest effect, it demonstrates that an HIV vaccine is possible. Click here (http://www.avac.org/ht/a/GetDocumentAction/i/3597) to learn more about those results.
The previous studies did not have a protective effect, but each offered some insight into how to conduct vaccine studies, and gave clues about vaccine development. Click here (http://www.avac.org/ht/d/sp/i/352/pid/352) to learn more about those and other studies.
All research activities at the HIV Research Section are fully in compliance with international standards of the ethical protections (http://www.hvtn.org/community/ethics.html) for research studies, and special standards for HIV studies. All of our research activities are conducted with input from our Community Advisory Group (http://www.helpfighthiv.org/board.htm), and under the approval of the UCSF Committee on Human Research (http://www.research.ucsf.edu/CHR/index.asp).
Participant safety is the number one concern in our vaccine studies. Study participants go through a process of informed consent before enrolling in the study during which they learn all of the risks, benefits, and responsibilities of study participation.
Once enrolled, participants have access to study staff at all times to address any questions or concerns. Participants can withdraw from the study at any time.
There's something everyone can do to help find a vaccine:
- Be an informed advocate for vaccine studies, talk to your friends about them, and support participants you know.
- Invite us to come and speak to your community or volunteer group about vaccine studies. Call Gavin Morrow-Hall, Community Education Coordinator, at (415) 437-4696 for more information.
- Become a part of our Community Advisory Group http://www.helpfighthiv.org/board.htm.
- Host a vaccine dinner party - we'll treat you and up to ten friends to dinner, and come to your home to conduct a fun, interactive workshop about HIV vaccines. Call Gavin at (415) 437-4696 for more information.
No, you cannot get HIV from an HIV vaccine. The vaccines we are testing do not contain any whole, live, killed, or weakened HIV. Instead, the vaccines use man-made imitations of pieces of the virus. The idea is to trick your body’s immune system into creating a response to a threat that isn’t there. Hopefully, then, if you are ever exposed to HIV, your body will know how to fight it.
Think of it like parts of a car. If someone handed you a steering wheel and some tires, you would know they were parts from a car, and you could practice steering or changing a flat. But you couldn’t use those parts to get yourself to work.
HIV vaccines are tested in laboratories and animals before people. Only the vaccines that look safe and promising are moved into testing with people in placebo-controlled, double blind studies.
"Placebo-controlled" means that volunteers in the studies may receive either the vaccine, or a placebo, like a dummy shot. "Double blind" means that neither the researchers nor the participants will know who received which shot until after the study is over. At the end of the study, investigators look for differences between the vaccine and placebo groups to see if the vaccine was safe and effective.
The vaccines are tested in several phases. In early phases, or safety trials, a small group of people at very low risk for HIV receive vaccine or placebo to test for side effects and other safety concerns. If a vaccine looks safe, a larger group of people is given the vaccine to test what might be the best dose of vaccine, and if the body is making a promising immune response. If a vaccine looks safe and promising, it is moved into a large efficacy trial, where a large group of people at risk for HIV are given either vaccine or placebo, and researchers measure whether the vaccine is protective against HIV.
All participants are offered extensive education, so that they know which trial they are enrolling in, and that they may receive vaccine or placebo. All participants receive regular risk reduction counseling and testing to help them reduce their risk for HIV.
We are often recruiting for more than one study at the same time. When you call us, we’ll be able to figure out which study is the best fit for you. Generally, there are 5-7 visits to our office in the first six months, and after that one visit every 3 months until the study is finished. Visits are usually carried out during business hours, between 7am and 5:30pm.
The vaccines we are testing have all been tested in animals, and many have already been tested in other people, so we have a good idea of the most common side effects. Those tend to be soreness at the site of injection, and some people also experience mild cold-like symptoms, such as a fever or headaches, for a day or two after the vaccine. Because it is an experimental product, there may be other side effects we don’t know about.
If you receive a vaccine during the study, you might test positive on a standard HIV test for an unknown period of time. The good news is that we can absolutely tell the difference between someone who has HIV, and someone who has antibodies because of the vaccine. The stickier part is that if you are tested at a regular HIV testing site, they might not know how to tell the difference between a vaccine-positive and an actual infection.
The reason for the false positive is that a vaccine might cause your immune system to make antibodies against HIV. Antibodies are your body’s way of fighting infection, and if a vaccine elicits them, it might be good sign the vaccine is making an immune response. The problem is that most HIV tests actually look for the antibodies, rather than the virus itself. So at a regular testing site, you might be told you were HIV positive, even though you just have antibodies.
We will be able to tell you your true HIV status, and we can provide documentation to anyone you need for us to. We will also provide you with HIV testing, or arrange for appropriate testing for you if you move, for as long as you test false positive.
