CUTHIVTHER 001

A randomized phase I/II study to assess the safety and immunogenicity of the DNA-GTU vaccine administered by two novel methods compared to placebo in HIV-infected patients on antiretroviral therapy

Examining the safety and effectiveness of the DNA-GTU vaccine administered in two different ways to a placebo in HIV patients on antiretrovival therapy

What is this study about?

The aim of this study is to assess the safety and potential of the vaccine. The vaccine is called the DNA GTU-multiHIV B clade vaccine. It has been tested in HIV-infected people who were not on treatment and reduced the amount of virus detectable in the blood. We will test how well the vaccine stimulates the immune system, compared to volunteers who will be randomised to receive a placebo vaccine. The placebo will be Sodium Chloride BP (water with salt). The vaccine we are testing does not contain any active (live) or denatured (killed) whole HIV.

At present, it isn’t clear which route of giving this HIV vaccine is best at being able to stimulate the immune system against HIV infection. In the previous trial in HIV-infected individuals, the vaccine was injected into the skin (intradermal) or into the muscle (intramuscular). We know from other studies that the route influences the nature of the immune responses.

This study will look at two methods of giving the HIV vaccine:

Electroporation - a small electrical pulse will be applied with the vaccine into the upper thigh. The pulse is instant and the whole procedure is completed within a similar time to a normal vaccination.

Transcutaneous - a needle free method. The vaccine is spread onto a small area of skin after removal of the hairs (like waxing). The skin is then covered with a plaster for 24 hours. This group will also receive an ordinary intramuscular injection of the vaccine into the upper thigh.

Type of study

Randomised trial

Contact details

mrcctu.ctuenquiries@ucl.ac.uk

Who is funding the study?

European Commission under the 7th Framework Programme – CUT’HIVAC Grant Agreement.

When is it taking place?

23rd Dec 2009 to 31st Dec 2015

Where is it taking place?

St Mary’s Hospital, Paddington, London

Who is included?

30 HIV-infected male and female volunteers aged 18-45 years, with a BMI of between 19-30, who have been on treatment for HIV for at least 6 months and no virus is detectable in the blood.