A Phase I clinical trial to assess the safety and immunogenicity of three HIV GTU® MultiHIV DNA immunisations administered via the Intramuscular, Intradermal and Transcutaneous routes in healthy male and female volunteers.

CUTHIVAC 001 will look whether the DNA vaccine is safe and whether the way it is administered influences the way it stimulates the immune system.

What was this study about?

There is currently no cure for HIV and although treatment is available, it is inaccessible to many, has to be taken for life and can be associated with side effects. It is widely accepted that a vaccine for HIV would be the best way to prevent infection and although there has been one encouraging trial in Thailand, there is currently no vaccine available.

This study will assess the DNA GTU®-multiHIV B vaccine which has previously been administered via the conventional intramuscular route in untreated HIV-positive people in South Africa and shown to reduce the amount of circulating HIV virus in the blood. . We are interested in whether we can improve vaccination efficiency and/or tailor immune responses by administering the vaccine via other routes. At present, it isn’t clear which route of giving the vaccine is best at stimulating the immune system to target HIV.

All healthy volunteers will be given the vaccine Intramuscularly (into a leg muscle) and will then have an equal chance of receiving additional vaccine via one of the following:

(i) Transcutaneously - a novel needle free method which delivers the vaccine via hair follicles or
(ii) With Electroporation – using a device which delivers a small pulse of electrical current to the muscle or
(iii) Intradermally – another commonly used route in which vaccine is injected in the top layer of skin.
We are primarily interested in T-cell responses as the vaccine was designed to target these responses, which have been shown to play a role in killing HIV infected cells.

What difference did this study make?

We showed that administering the vaccine intramuscularly with electoporation resulted in the highest proportion of participants responding, and potent inhibition of HIV in the laboratory. However, the transcutaneous route modified the response, shifting it towards a pattern associated with protection in the mucosal tissues.

The full publication can be found here.

Type of study

Randomised trial

Contact details

Who funded the study?

European Commission under the 7th Framework Programme

When did it take place?


Where did it take place?

St Mary’s Hospital, Paddington, London

Who was included?

27 healthy adult men and women aged 18-45 years, at low risk of HIV completed all 3 vaccinations.