A phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in combination with a Clade C ENV protein in healthy HIV-uninfected adults
How does the body’s immune system respond to a new vaccine called DREP-HIV-PT1, and is it safe to use?
What is this study about?
EHVA P01 is a study that is looking at the use of a new vaccine against the HIV virus.
There are two parts to the study:
- The first part is open-label and will assess the safety of this vaccine, since this will be the first time that it has been used in humans.
- The second part aims to see how well and for how long the vaccine activates the immune system.
This trial is not looking at whether or not the vaccine is effective in terms of protecting against HIV, it is just assessing whether and how well the immune system responds.
Type of study
Who is funding the study?
The trial is funded by the European Commission Horizon 2020 Research and Innovation Programme (Grant no. 681032); Swiss State Secretariat for Education, Research and Innovation (SERI) (Grant no. 15.0337); and the Vaccine Research Institute/Inserm-ANRS.
When is it taking place?
August 2022- December 2024 (programme funded from January 2016)
Where is it taking place?
Four clinical research centres in Europe (UK, France, and Switzerland). Recruitment in the UK will take place at Chelsea and Westminster Hospital.
Who is included?
Healthy HIV and hepatitis C-negative adults aged 18-55 using highly effective methods to avoid pregnancy in self or partner with no history of anaphylaxis, severe allergy or exposure to experimental vaccines.