How Many People Will Be In This Study And Who Can Join?
The study will enroll about 5400 men and women in South Africa. To join this study, a person must be healthy, between 18 and 35 years old, and not infected with HIV (HIV-negative). A person must be willing to have medical check-ups and regular HIV counseling and testing. Women cannot be pregnant or breastfeeding. There are also other criteria that must be met in order for a person to be eligible to join the study.
What You Can Expect If You Decide To Volunteer?
We will answer any questions you have to make sure you understand what is involved with participating in this study.
- You will have physical exams that include blood tests. Blood samples will be used to test for HIV infection; how your immune system responds to the study products, limited genetic testing and other tests that will help researchers understand the participant’s health and immune system better.
- Over the course of the study, you come to the clinic approximately 16 times over 3 years. At 5 of these visits you will get the study injections of the study vaccines or the placebos. You will get a total of 8 injections during the study.
- You will be asked to keep track of how you feel for the 3 days following each injection visit. You and the site staff will be in contact about how you’re feeling during this time.
- Follow-up visits will include HIV counseling and testing, and answering questions from the clinic staff. These visits will be shorter than visits where you get study injections.
- You will be told about the optimal ways to protect yourself from HIV infection.
When And Where Will The Study Be Done?
The study began enrolling participants in October 2016 and will be conducted in 15 clinical research sites throughout South Africa.