May 18 is HIV Vaccine Awareness Day
How would an HIV vaccine work?
An HIV vaccine could work by teaching the body's immune system to recognize HIV in one of two ways. A strong immune response to a vaccine could protect a person from becoming HIV infected if exposed. Or a vaccine could also work by helping a person's body better fight HIV if that person does become infected.
What is the process?
To create HIV vaccines, scientists first test products in labs and then in animals to assess safety and immune responses. If these results look promising, three major phases of studies may be conducted in people. Very few vaccines make it all the way through to be an approved product. If a study vaccine completes all three phases with good results, it might be approved for general use by drug regulatory agencies around the world, such as the US Food and Drug Administration.
In Phase I, the study vaccine is tested in a small number of HIV-negative people to see if there are side effects and to see if the body's immune system responds to the vaccine.
In Phase II, researchers test the study vaccine in hundreds of HIV-negative people and continue to look at safety as well as looking at how well the body's immune system responds to the study vaccine. These studies may also look at when to give the vaccine and at what dose.
Phase III studies involve thousands of HIV-negative people. They continue to assess safety, and they determine if the study vaccine works to prevent HIV infection, or if it can help to control the disease if people do become infected.
Can study volunteers get HIV from the study vaccine?
No. It is impossible for anyone to get infected with HIV from the study vaccines because there is no actual HIV in them.
How are the rights and well being of study participants protected?
Several groups of experts at the HVTN and at the National Institutes of Health review our studies to be sure that they appear safe and that protections for volunteers have been included. The Institutional Review Board or Ethics Committee at each research clinic is charged with ensuring the safety and well being of the volunteers. For large studies, an independent Data and Safety Monitoring Board (DSMB) reviews data during the study and can recommend a study be stopped if it appears that volunteers are being placed at risk.
Representatives from local Community Advisory Boards (CABs) also review studies during the planning stages for acceptability to their communities from a cultural, ethical, and scientific perspective. CABs also help researchers to design materials that explain the study to potential study volunteers in language that is understandable.
Join the global effort
More than 30,000 people around the world have volunteered in an HIV vaccine study. Thousands more have participated on Community Advisory Boards. Find out how you can get involved by contacting the site nearest you. If you are a man who has sex with men in the United States, visit http://hopetakesaction.org.
Different studies enroll different kinds of people at locations around the world. Contact the site near you to learn more about open studies in your area.