Phase I Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers
The purpose of this study is to test experimental HIV vaccines to see if they are safe. HIV is the virus that causes AIDS. The vaccines use a live adenovirus as a carrier (or transporter). Adenoviruses are naturally occurring viruses that typically cause symptoms of a cold or conjunctivitis (a superficial eye infection). We hope that the adenovirus carrier will help the vaccines stimulate an immune response against HIV. An immune response is the body’s release of cells and substances that protect the body from infection and foreign matter. Another important goal is to see whether different ways of giving the vaccines cause different immune responses. We also want to see if the adenovirus in the vaccines is contagious or spreads to others. The study vaccine will not expose you to HIV infection. Volunteers will be compensated.
We plan to enroll up to 110 subjects who are 18 to 49 years old and in good general health that will receive one or both of the study vaccines or placebo. A placebo is an inactive sugar-water solution that looks like the study vaccines but does not contain the vaccine or any part of the viruses. Researchers use a placebo to see if the study vaccine is more or less safe or effective than not taking anything. We estimate that an additional 110 household or intimate contacts will be enrolled in this study.
The study vaccines are available in two routes: oral (whole pills swallowed) or intranasal (sprayed in the nose). Experiments in 125 people with an oral capsule form of another adenovirus vaccine have shown little spread of the adenovirus from human to human. We don’t know if the intranasal forms are more likely to spread the adenovirus than the oral capsules. Therefore, if you want to be considered for the intranasal vaccines, you must be willing to be hospitalized for five to seven days or longer if needed for medical reasons.
Since the vaccines contain a live adenovirus, there is a possibility that you can infect other people with adenovirus. Therefore, all of your intimate contacts must join this study. An intimate contact is someone you will kiss on the mouth, have intercourse with, or have oral sex with during the study. You will be asked to talk to your intimate contacts about your plans to participate in this study. If you want to participate, your intimate contacts will need to notify the study team and set up a discussion about the study and their potential participation.
Your household contacts may also participate in this study. A household contact is anyone that you live in the same house or apartment with. We will ask you to discuss this study with your household contacts and ask them to contact the study team if they are interested in participating. Your household contacts do not have to participate in this study for you to participate.
Your total time of participation in this study will be 14 months. During this time, you will have one seven-day hospital stay (if you do the intranasal vaccine), two additional vaccination visits, and seven follow-up visits. You may need additional follow-up visits if you experience adenovirus symptoms or vaccine side effects. You will be monitored throughout the study for vaccine-related side effects and treated at the National Institutes of Health (NIH) hospital in case any occur.
At the time you enroll in the study, you must have a negative HIV antibody test. An HIV antibody test is the usual way to test for HIV infection. After the study vaccinations, it is very likely that you will have a positive result on common HIV tests that look for antibody. If you get an HIV test somewhere else, people giving the test may think you have HIV infection. For this reason, you should get HIV tests only at NIH during the study. We will use a testing method that looks for the presence of HIV virus. This method will show if a true infection is present.
We do not know how long HIV antibodies from the experimental vaccinations will last in your blood. When this study finishes, we can assist you with obtaining tests that can tell the difference between antibody from study vaccinations and a true HIV infection. This can be done either by testing in another NIH research protocol or by advising your private healthcare provider on testing methods.
If someone believes you have HIV infection when you do not, then you could face discrimination. For example, you could be denied health care, employment, insurance, a visa, or entry into the military. You may also call the clinic if you need assistance or have questions or concerns.
It is important for you to continue to avoid behaviors associated with the risk of getting HIV infection.
Last Updated February 23, 2015