EHVA P01

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.

Is a new vaccine called DREP-HIV-PT1 safe and how does the body’s immune system respond to it?

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.

One part is open-label to assess the safety of this vaccine, since this will be the first time that it has been used in humans.

The second part is to see how well, and for how long, the vaccine activates the immune system. But this trial is not looking at whether or not the vaccine is effective in terms of protection against HIV. It is just assessing whether and how well the immune system responds.

Type of study

Randomised trial

Contact details

mrcctu.ehva@ucl.ac.uk

Who is funding the study?

European Commission Horizon 2020 Research and Innovation Programme (Grant no. 681032)

Swiss State Secretariat for Education, Research and Innovation (SERI) (Grant no. 15.0337)

Vaccine Research Institute/Inserm-ANRS

When is it taking place?

Dec 2021-June 2023

Where is it taking place?

At 3 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 age 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.