Clinical Trial Of New HIV Vaccine VIR-1388 Begins In The United States and South Africa

A trial of a preventive HIV vaccine has started in the United States and South Africa. The Phase 1 trial will check if the vaccine called VIR-1388 is safe and if it can make the immune system respond to HIV.  The National Institute of Allergy and Infectious Diseases (NIAID) has provided financial and scientific support throughout the lifecycle of this HIV vaccine concept.  NIAID is contributing funding for this research.

VIR-1388 is made to teach our immune system to create special cells called T cells. These T cells can recognize HIV and tell our immune system to fight against it. This fight can prevent the virus from causing long-term infection. VIR-1388 uses a virus called cytomegalovirus (CMV). Cytomegalovirus is a weakened version of CMV that doesn't make participants sick. 

CMV has been around in many people for a very long time, and most people don't even know they have it because it usually doesn't cause any problems. CMV stays in our bodies for our whole lives, and that's good for this vaccine because it can keep the HIV vaccine material in our bodies for a long time. This might help our immune system remember how to fight HIV for a longer period, which is important because some other vaccines don't last as long.

NIAID has funded the development and discovery of the CMV vaccine vector since 2004. NIAID is funding this trial with the Bill & Melinda Gates Foundation and Vir Biotechnology, based in San Francisco. 

This HIV Vaccine Trials Network is taking place at four places in South Africa and six in the United States. This network will enroll 95 HIV-negative participants. Participants will be randomly given to one of four study arms: three arms will each receive a different dose of the vaccine, and one will receive a placebo. 

To make sure the people in the study stay safe, they will only include those who already have CMV but don't have any symptoms from it. They will get some early results from the study around the end of 2024. Some volunteers might also choose to be part of a longer study that will keep track of them for up to three years after they get their first vaccine dose.