Conducted in SouthAfrica, the aim of the study was to evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of RUTI® compared to placebo in subjects (HIV+ and HIV-) with latent tuberculosis infection.
The double-blind, randomized, placebo-controlled CT demonstrated the tolerability of RUTI® in infected subjects.The immunogenicity profile of RUTI vaccine in LTBI subjects suggested considering one single injection of one of the highest doses in future trials.
This has been another important step in the clinical development of RUTI® towards commercialization, a vaccine which was designed, patented and initially developed in our Unit by the leadership of Dr Cardona, who was its inventor. The development was further transfered to a spin-off company specifically created to accomplish this objective, Archivel Farma SL).In this sense, the relationship with this company has led to personnel (students) training, generation of thesis works, manuscripts and patents in collaboration, and a profitable transfer of knowledge. The company is now seeking funding to complete the clinical development of the vaccine with the aim to arrive to the market.
You can read the paper here.