HIV Vaccine to Be Tested in US, South Africa

The National Institutes of Health on Wednesday said it will launch clinical trials for a novel HIV vaccine in the U.S. and South Africa.

"NIH scientific advances continue to be vital to achieving our national goal of ending the HIV epidemic by 2030," Assistant Secretary of Health Rachel Levine wrote on X.  "This HIV vaccine clinical trial is another step toward our bold goal."

The Phase 1 trial, named HVTN 142, evaluates the safety and efficacy of the new HIV vaccine candidate VIR-1388 in generating an HIV-specific immune response.

VIR-1388, the innovative vaccine, employs a milder form of cytomegalovirus (CMV) to transport HIV vaccine components into the immune system. This approach addresses the challenge of diminishing immunity that has hindered previous HIV vaccine endeavors.

"CMV has been present in much of the global population for centuries" and presents often with no or few symptoms, the NIH said in a public announcement. "CMV remains detectable in the body for life, which suggests it has the potential to deliver and then safely help the body retain HIV vaccine material for a long period."

CMV, often asymptomatic and unnoticed by carriers, can persist in the body indefinitely. This resilience suggests its potential to effectively transport and sustain HIV vaccine material over an extended duration, potentially surmounting the declining immunity associated with shorter-lasting vaccine vectors.

The NIAID-funded HIV Vaccine Trials Network will conduct a study across 10 U.S. and South African locations, enrolling 95 HIV-negative individuals with asymptomatic CMV. Initial results are expected by late 2024.

Creating an HIV vaccine is challenging due to the virus' rapid mutation and replication. In March 2022, NIH announced mRNA HIV vaccine trials, leveraging mRNA's adaptability to effectively target the virus' mutations.

"There's an obvious agreement that we need a vaccine," Paul Volberding, Infectious Disease News chief medical editor, said in April when a sizable clinical trial initiated in 2019 officially halted. "This has proved to be probably the toughest vaccine scientists have worked to create."

By the end of 2022, approximately 39 million people, including 1.5 million children, were living with HIV, according to the WHO. In Africa, nearly 1 in 25 adults has HIV, constituting over two-thirds of all cases. Over 40 million lives have been claimed by HIV-related illnesses since the epidemic's inception over four decades ago.

Since 2004, the National Institute of Allergy and Infectious Diseases, under the auspices of the NIH, has provided funding for research on CMV vector vaccines for HIV. The Bill & Melinda Gates Foundation and San Francisco-based Vir Biotechnology supported the clinical trial financially.

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