Spanish biotechnology firm Aelix Therapeutics has commenced patient enrolment in a Phase I clinical trial (AELIX-002) of HTI vaccine to treat patients infected with HIV.
Designed by the firm’s chief scientific officer Dr Christian Brander and colleagues, HTI vaccine immunogen combines specific HIV regions that are enriched with T-cell responses in individuals who can control the virus without antiretroviral drugs.
The randomised, double-blind, placebo-controlled Phase I AELIX-002 will evaluate the safety, tolerability and immunogenicity of the vaccine.
To enhance the immune responses to HIV, the vaccine will be given in a prime-boost regimen, including an initial DNA vector and a subsequent Modified Vaccinia Ankara virus (MVA) vector.
Aelix Therapeutics chief medical officer Dr Ian McGowan said: “Developing a safe and effective therapeutic HIV vaccine that frees patients from the burden of antiretroviral therapy could be considered as the final frontier in HIV research.”
Intended to optimise the expansion of immune responses associated with the vaccine, the trial’s enrolment will include patients who were diagnosed less than six months after their initial HIV infection and immediately treated using antiretroviral therapy (ART).
The trial is being conducted at the University Hospital Germans Trias i Pujol (HUGTIP) in Badalona, Spain, and will be led by investigators from the IrsiCaixa AIDS Research Institute and the Fight AIDS Foundation.
Trial’s HUGTIP principal investigator Dr Beatriz Mothe said: “The vaccine has been designed with the goal of refocusing patients' immune response to especially vulnerable sites of HIV so that they can control their HIV infection without further antiretroviral therapy.”
Results from the Phase I trial for HTI vaccine are expected to be reported next year.