clinical-and-translational-research-header

clinical-and-translational-research-header

Clinical and Translational Research in Experimental Medicine and Biomedicine

Clinical and translational research

Clinical research at York is a joint venture, utilising the expertise and resources of the University of York, Hull York Medical School and York Teaching Hospital NHS Foundation Trust (YTHFT).

We provide an environment that can deliver early phase trials (phase I and phase II) or support translational scientific research within York. We also design and support clinical studies in Asia, Africa, and South America. To date, Clinical Trials of Investigational Medicinal Products (CTIMP) trials delivered by York academics at York Hospital have been jointly sponsored by the University of York and YTHFT. There is also a clinical suite within the Department of Biology, University of York, where unievrsity-sponsored non-CTIMP studies can be conducted.

Our Experimental Medicine and Biomedicine theme evolved from the Centre for Immunology and Infection, which was established in 2004. The Centre established a close working relationship with YTHFT in 2009 to support basic and translational research. Over these years, we have successfully delivered several phase I and II trials.

The research has covered a number of areas in Infectious Diseases, HIV & Immunology, but we have also delivered clinical trials in oncology, ophthalmology and rheumatology. In most cases, we have successfully recruited to time and target.

Following the University’s acquisition of a Human Tissue Authority research license, the York Tissue Bank was established. This initiative aims to develop networks with the clinical care teams and provide researchers from both the hospital and university with access to human tissue for basic and translational research.

Ongoing projects

  • A phase IIb double-blind placebo-controlled randomized clinical trial (RCT) to evaluate the therapeutic efficacy of ChAd63-KH vaccine in patients with persistent post kala-azar dermal leishmaniasis (PKDL) in Sudan.
  • A phase IIb double-blind, placebo-controlled RCT to evaluate ChAd63-KH for the prevention of PKDL in previously treated visceral leishmaniasis patients in Sudan.
  • A phase 4 RCT with immunological endpoints of two different HPV vaccines given as 1,2, or 3 doses in 9-12 year old girls in Tanzania
  • The development of a Controlled Human Infection Model (human challenge study) of Leishmania major in healthy volunteers
  • A multicentre study in East Africa to determine the immune set point after treatment for visceral leishmaniasis using sodium stibogluconate / paromomycin combination therapy.

Completed projects

  • LEISH1: a phase 1 First-in-Human study to assess the safety and immunogenicity of a new Leishmania vaccine candidate ChAd63-KH.
  • NCRN464: A commercial randomised, double-blind, placebo-controlled, phase I/II trial of RNActive®-derived Cancer Vaccine (CV9104) in asymptomatic or minimally symptomatic patients with metastatic castrate-refractory prostate cancer.
  • ADON: A commercial 48-week, double-blind, randomised, multi-centre, parallel-group study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute de-myelinating optic neuritis.
  • DAPIDAR: A randomised, double blind phase I study to assess the safety, pharmacokinetics and pharmacodynamics of single and 14 days dosing with two anti-HIV vaginal microbicide formulations containing either Darunavir, or Dapivirine plus Darunavir.
  • RADIUS: Rheumatology clinical trial, sponsored by Merck.
  • CV-9104-004: Oncology clinical trial.
  • MABGEL1: phase 1 clinical trial of a triple anti-HIV monoclonal antibody vaginal microbicide.
  • MUCOVAC2: Mucosal and systemic HIV vaccine phase 1 clinical trial.
  • GENTICEL: Therapeutic HPV vaccine clinical trial, in LSIL, sponsored by Genticel.
  • GSK Hand Osteoarthritis: Rheumatology clinical trial, sponsored by GSK.
  • IgA Renal: Renal clinical trial, sponsored by Merck.
  • NASH: Hepatology clinical trial.