The study evaluated the safety, efficacy and immunogenicity of AELIX’s HIV vaccine

Aelix – a company specialising in the discovery of therapies for HIV– has revealed the results of its AELIX-002 clinical study.

AELIX-002 research was conducted in partnership with Gilead Sciences at the IrsiCaixa AIDS Research Institute. The centre has been jointly promoted by the ‘la Caixa’ Foundation and the Department of Health of the Generalitat de Catalunya.

The study evaluated safety, tolerability, efficacy and immunogenicity of Aelix’s HIVACAT T-cell immunogen (HTI) therapeutic HIV vaccine in people living with HIV and are receiving early treatment. Consequently, the research has achieved all its primary and secondary endpoints.

The trial also focused on the efficacy of the vaccination and demonstrated that the use of the Aelix HTI vaccine can allow a significant length of time without AntiRetroviral Therapy (ART). Furthermore, the strength of the vaccine-induced T-cell response, with prolonged periods off ART.

The emerging results now support the development of combination strategies, based on the HTI vaccine, to control HIV without the need for ongoing ART.

A second clinical study – AELIX-003 – is also being conducted in collaboration with Gilead. This active phase 2 study is designed to evaluate the HTI vaccine in combination with Gilead’s investigational Toll-Like Receptor 7 agonist, vesatolimod, in people with HIV on antiretroviral therapy.

Vesatolimod is an immune modulator being evaluated as part of an investigational combination regimen that could potentially lead to viral remission. During this study, vesatolimod is expected to enhance the vaccine-induced immune response leading to the elimination of virus-infected cells.

“The positive results from this trial show that it is possible to induce an immune response in a person living with HIV which enables them to improve the suppression of the virus in the absence of antiretroviral medication,” reflected Dr Beatriz Mothe, associate researcher at the IrsiCaixa AIDS Research Institute.

“A safe and effective HTI vaccine could become the backbone of combination strategies to achieve complete viral suppression, which ultimately is our common goal,” he added.

“We are excited to have published the data on this important study in such a prestigious journal, reaching a wide readership. Our T-cell vaccine approach has the potential to play a critical role in strategies to cure HIV infection,” concluded Dr Christian Brander, chief scientific officer at Aelix and principal investigator at IrsiCaixa.