Dora ha scritto:Presso il Beth Israel Deaconess Medical Center di Boston, comincia uno studio clinico di fase I, randomizzato e controllato con placebo, su due diversi regimi del vaccino Ad26.Mos4.HIV in funzione terapeutica, per valutarne sicurezza e tollerabilità in 26 persone con HIV controllato dalla ART:
Inizio previsto a febbraio 2018; conclusione a marzo 2020.
Dal comunicato stampa di Johnson & Johnson in occasione della presentazione dei dati ad interim dello studio TRAVERSE (HPX2004/HVTN117/IPCAVD011; ClinicalTrials.gov number NCT02788045) alla HIV Research for Prevention Conference (HIVR4P), che si è tenuta in questi giorni a Madrid:
- - TRAVERSE data add to body of clinical evidence supporting further study of Janssen’s investigational mosaic-based vaccine regimen -
[...] Johnson & Johnson today announced the primary analysis of immune response data for a tetravalent mosaic-based preventive vaccine against HIV-1 infection in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In the early-stage, Phase 1/2a TRAVERSE study among HIV-negative volunteers, a vaccine regimen including a tetravalent (4-valent) mosaic viral vector was compared to a regimen containing a trivalent (3-valent) mosaic vector. At 28 weeks, the tetravalent mosaic-based vaccine was well tolerated and significantly enhanced the breadth of immune responses to different HIV-1 strains compared to the trivalent version. These Phase 1/2a data will be shared this week at the 2018 HIV Research for Prevention Conference (HIVR4P) in Madrid, Spain. The tetravalent vaccine is now in large-scale efficacy testing. [...]
Developing an effective vaccine against HIV has proven challenging due in part to the significant global genetic diversity of the virus. Janssen’s investigational vaccine regimen contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes. Both the trivalent and tetravalent versions of the mosaic-based vaccine contain viral vectors that deliver immunogens designed to elicit immune responses against the three main proteins of HIV (Env, Pol and Gag). But the tetravalent formulation adds a fourth immunogen, which is Env-focused and designed to enhance the breadth of immune responses against HIV-1 subtypes.
These new TRAVERSE results build on encouraging safety and immune response results for the mosaic-based vaccine from the Phase 1/2a APPROACH study that were shared at the 22nd International AIDS Conference (AIDS 2018). Early findings from TRAVERSE and APPROACH were critical in enabling the first large-scale efficacy study for a mosaic-based vaccine regimen, HVTN 705/HPX2008 (also known as ‘Imbokodo’), to commence in November 2017. This Phase 2b study is assessing a regimen based on the tetravalent vaccine that was first clinically evaluated in the TRAVERSE study. It aims to enroll 2,600 women aged 18-35 in five sub-Saharan African countries to determine whether the vaccine is safe and efficacious in reducing HIV-1 infection in this population.
Results from HVTN 705/HPX2008 are expected in 2021. Additional large-scale studies will be needed to support licensure of the mosaic-based vaccine regimen against HIV-1. [...]
