Today, WHV joins the world in commemorating World AIDS Day in remembrance of those who have lost their lives due to AIDS-related illness and to show support for those living with HIV. This world AIDS day, we reflect back on the achievements of the HIV vaccine research community in 2021 and acknowledge the ongoing critical need to accelerate the development of a safe and effective HIV vaccine in order to reduce HIV infections around the world.
Over the past year, WHV has accomplished two major clinical development milestones relevant for the fight against HIV: In March of 2021, the phase 1a HVTN124 trial evaluating the safety and immunogenicity of WHV’s polyvalent DNA/Protein HIV Vaccine (PDPHV) candidate formally concluded without the occurrence of any safety concerns and secondary analyses showed remarkable immunogenicity data. This trial was sponsored by the the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN). Results from HVTN124 were presented at the HVTN Full Group Meeting in May. Only a few months later in July, the subsequent phase 1b WHV138 trial was launched, aiming to further characterize the safety and immunogenicity profile of PDPHV in a simplified vaccination schedule. This is the first time for WHV to act as the sponsor of a clinical trial since the biotech company was established only three years ago. WHV138 is already half-way enrolled and is anticipated to conclude in the Fall of 2023. Plans for a phase 2 trial are already underway as WHV prepares to move the vaccine candidate into the next testing stage.
There is growing evidence that a safe and effective as well as globally relevant HIV vaccine needs to not only be multigenic, polyvalent, and heterologous, but also be able to elicit a multi-factorial immune response in order curb the HIV pandemic manifesting a large HIV-1 subtype diversity. The vaccine candidate PDPHV is currently the only product tested in humans that targets all four major circulating subtypes of HIV-1 responsible for the global HIV burden. Its formulation is based on decades of research conducted by Dr. Lu’s lab at the University of Massachusetts Medical School (UMMS) in Worcester, MA. The vaccine consists of a 5-plasmid Env (A, B, C, E)/Gag (C)-expressing DNA vaccine and a recombinant gp120 protein vaccine of which the antigens are matched to the DNA plasmids. Results from Dr. Lu’s pre-clinical studies in rabbits, as well as early phase trials in humans indicate that when used in a DNA/Protein prime-boost regimen, PDPHV has the potential to elicit cross-protective, high magnitude and large breadth immune responses. With such a low-risk safety profile and very promising immunogenicity results, the vaccine candidate PDPHV could have a major impact on the HIV vaccine field, advancing it further towards developing a safe and effective HIV vaccine that can be applied worldwide.
WHV is honored to engage with a number of stakeholders joining efforts in ending the HIV pandemic that has caused hundreds of thousands of deaths and is still affecting millions of people today. Together with leading HIV vaccine researchers and renowned infectious disease specialists, WHV strives to advance the HIV vaccine field and aspires that AIDS will one day be a vaccine preventable disease.
