How Many People Will Be In This Study And Who Can Join?
The study will enroll about 2600 women in South Africa, Malawi, Mozambique, Zambia, and Zimbabwe. To join this study, women must be healthy, HIV-negative, and between 18 and 35 years old. These women must be willing to have medical check-ups and regular HIV counseling and testing. They cannot be pregnant or breastfeeding. There are also other criteria that must be met 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; to check how your immune system responds to the study vaccines; for 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 will go to the clinic approximately 17 times over 3 years. At 4 of these visits you will get injections of the study vaccines or the placebos. In total, you will receive six injections during the study.
- You will be asked to keep track of how you feel for the 3-7 days following each injection. After this time, you and the site staff will be in contact to see how you are feeling.
- The 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 receive injections.
- The HIV counseling will advise you about the best ways to protect yourself from HIV infection during the study.
When And Where Will The Study Be Done?
The study will begin enrolling participants in November 2017 and is taking place at multiple sites in South Africa, Malawi, Mozambique, Zambia, and Zimbabwe.