Phase 1 Open Label Study of Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers (WINGS)
Goal of Study
The purpose of the study is to test HIV vaccines to see if they are safe. It is not possible to get HIV through participating in the study. Vaccines are used to create resistance to a disease, or to prevent infection. The study vaccines will use a live adenovirus, the type of virus that typically causes cold symptoms. We hope that this adenovirus will help to stimulate an immune response against HIV.
The two adenovirus-based experimental vaccines we are using are called Ad4-Env150KN, and Ad4-Env145NFL. This is the first time these vaccines are being given to humans. The adenovirus-based vaccines used in this study have been genetically modified so that the adenovirus will produce pieces of protein from the HIV virus. As the virus reproduces it may cause an immune response to both adenovirus and to HIV proteins. Since these vaccines contain a live adenovirus, there is a possibility that the adenovirus can spread to other people. Studies in more than 100 people with oral capsule and intranasal forms of other adenovirus vaccines have shown little spread of the adenovirus from human to human. However, there is still a possibility that you can infect other people with adenovirus after receiving one of these vaccines. Therefore, all of your intimate contacts must join this study if you decide to participate. An intimate contact is someone you will kiss on the mouth, have intercourse with, or have oral sex with during the study.
Your household contacts may also participate in this study. A household contact is anyone that you live with in the same house or apartment. Your household contacts do not have to participate in this study for you to participate. If you join this study, you will need to take precautions to avoid infecting others with adenovirus. This includes hygiene practices to prevent viral spread such as covering coughs/sneezes, handwashing, and avoiding use of shared dishes and kitchen utensils.
The study vaccines are not made from actual HIV. They contain only pieces of the HIV virus and do not contain live HIV. It is impossible for the study vaccines to give you HIV. Study participants will receive three vaccines over a six-month period. The first two vaccines are given as a nasal spray, and the last as an injection. The study will last for 12 months, and include about 11 visits to the NIH.
All participants must be able to travel to the NIH for all study visits. We will enroll up to 100 participants. Volunteers will be compensated.
- You are 18 to 49 years old, and in good general health
- You are HIV-negative
- You are not living with anyone under the age of 18 or over 65
- You are not living with anyone with a chronic illness or suppressed immune system
- You are not living with anyone pregnant or breastfeeding
- If female, you are not pregnant, breastfeeding, or trying to become pregnant
- If you have an intimate partner, they must also participate in the study, but they will not receive the study vaccines
- If you live with others in your house or apartment, they may also participate in the study, but they will not receive the study vaccines