A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection
Can therapeutic vaccinations and/or monoclonal antibody treatment improve control of HIV replication?
What is this study about?
We are testing a combination of two therapeutic HIV vaccines (DNA and MVA) with or without a monoclonal antibody (Vedolizumab) in HIV positive people who are on treatment.
This is a phase I/II, multi-centre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants.
This study will measure:
- The impact of a prime-boost vaccine regimen (two different vaccines) on viral load
- The impact of immunotherapy (monoclonal antibody) on viral load
- The impact of combining the prime-boost vaccine regimen with immunotherapy on viral load.
To measure the impact of these strategies on viral load, we need to ask people in the study to stop HIV treatment for up to 24 weeks. We want to find out if vaccines lead to new immune responses and boost the body’s responses against HIV.
Type of study
Who is funding the study?
- European Union’s Horizon 2020
- Swiss State Secretariat for Education, Research and Innovation (SERI)
When is it taking place?
December 2015 - December 2020
Where is it taking place?
Hospital clinics in United Kingdom, France, Switzerland, Germany, Italy and Spain.
Who is included?
HIV positive participants who started HIV treatment after 2009 and at least one year ago, and are willing to stop cART for a short time or change treatment if required.