HIV Vaccine Clinical Trials Begin in the US and South Africa

Yesterday, the National Institute of Allergy and Infectious Disease (NIAID), a subset of the National Institutes of Health (NIH), revealed that phase 1 vaccine trials for human immunodeficiency virus (HIV) will begin enrolling participants in the United States and South Africa.

The launch of this clinical trial marks almost a decade of exploration, as research for this novel formulation began in 2004. According to the NIH press release, the Bill and Melinda Gates Foundation, the NIAID, and Vir Biotechnology have funded research and trials.

The trial will test the VIR-1388 vaccine using a cytomegalovirus (CMV) vector. According to the CDC, CMV is a common viral infection that affects one-third of children by age 5 and nearly half of adults by age 40.

In its active form, the viral infection can cause mild cold symptoms including fever, sore throat, fatigue, and swollen glands. Once infected, individuals with CMV will always have the virus. However, it remains inactive unless it is re-activated or the patient is re-infected with a different viral strain.

Essentially, the CMV viral vector is a weakened version of the virus used to deliver the vaccine material throughout the immune system. The vaccine material triggers the immune system to produce T-cells that recognize HIV and eliminate it before it becomes a chronic infection.

The randomized, double-blind, placebo-controlled multicenter study will occur across six sites in the US, including Birmingham, Alabama; Decatur, Georgia; Boston, Massachusetts; Philadelphia, Pennsylvania; Pittsburgh, Pennsylvania; and Seattle, Washington, in addition to four sites in South Africa.

Participants for this study will range from 18 to 55 years old and must be healthy. The researchers also ensure patients have an inactive, asymptomatic version of CMV. Additionally, the study will consist of two parts. In part A, the researchers will only recruit CMV seropositive persons of non-childbearing potential. Part B will allow people with childbearing potential; however, they will be required to use two forms of contraception.

They will be enrolled in one of four participant groups. Three groups will receive varying doses of the VIR-1388 vaccine, and the final group will receive a placebo.

“HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts,” said Carey Hwang, MD, PhD, Vir’s Senior Vice President, Clinical Research, and Head of Chronic Infection, in the VIR press release. “The initiation of our first clinical trial evaluating VIR-1388 is an important clinical milestone in our pursuit of developing an HIV vaccine, and we are grateful to all our partners for their support of this Phase 1 trial. We are hopeful that our unique approach will help close the longstanding public health gap in HIV prevention.”