image: Transmission electron micrograph of HIV-1 virus particles from infected H9 cells, produced in cell culture. The particles exhibit two stages of replication: the two “arcs” are immature particles budding from the plasma membrane of the cell, and the center spherical particle is a mature form in extracellular space. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. view more
Credit: NIAID
WHAT:
A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.
VIR-1388 is designed to instruct the immune system to produce T cells that can recognize HIV and signal an immune response to prevent the virus from establishing chronic infection. VIR-1388 uses a cytomegalovirus (CMV) vector, meaning a weakened version of CMV delivers the HIV vaccine material to the immune system without causing disease in the study participants. CMV has been present in much of the global population for centuries. Most people living with CMV experience no symptoms and are unaware that they are living with the virus. 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, potentially overcoming the waning immunity observed with more short-lived vaccine vectors.
NIAID has funded the discovery and development of the CMV vaccine vector since 2004 and is funding this trial with the Bill & Melinda Gates Foundation and Vir Biotechnology, based in San Francisco. The trial is sponsored by Vir and conducted through the NIAID-funded HIV Vaccine Trials Network (HVTN) as study HVTN 142.
HVTN 142 is taking place at six sites in the United States and four in South Africa and will enroll 95 HIV-negative participants. Participants will be randomly assigned to one of four study arms: three arms will each receive a different dose of the vaccine, and one will receive a placebo. To optimize participant safety, this study will only enroll people already living with asymptomatic CMV. Initial results are expected in late 2024, and an optional long-term sub-study will continue to follow volunteers for up to three years after their first vaccine dose.
Additional information about the trial is available on ClinicalTrials.gov under study identifier NCT05854381.
WHO:
Carl Dieffenbach, Ph.D., Director of NIAID’s Division of AIDS, is available to discuss this research.
CONTACT:
To schedule interviews, please contact the NIAID News & Science Writing Branch, (301) 402-1663, NIAIDNews@niaid.nih.gov.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.
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