CUTHIVAC 001 - safety and immunogenicity of an HIV vaccine; version 1

• Research type

  Research Study

• Full title

  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

• IRAS ID

  81718

• Sponsor organisation

  Imperial Joint Research Compliance Office

• Eudract number

  2011-003171-11

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Our research is part of the global effort to develop a vaccine against HIV. We aim to develop a non-invasive, needle-free 'transcutaneous' vaccine. It will be a water-based solution which is placed on the surface of the skin of the upper arm, after the hairs have been stripped away. The active component of the vaccine - DNA which contains genes derived from the virus - will enter through the hair follicles from which the hair has been stripped. The DNA will get into cells, which will use the HIV genes to make copies of virus proteins. These proteins will stimulate the body's immune system and, we hope, make it able to protect against HIV infection. The research is to assess the safety of this approach, and how good it is at stimulating the immune system. We will combine the 'transcutaneous' vaccine with an 'intramuscular' version which is injected into the muscle of the thigh, and compare this combination with: intramuscular plus 'intradermal' (injection into the skin); and intramuscular with added 'electroporation' - use of a pulse of electricity to increase uptake of DNA vaccines.We will invite healthy men and women to take part in this research. Volunteers will first be assessed to ensure they are eligible to participate. A total of 30 will be enrolled and each will receive three vaccinations over the course of 12 weeks. We will assess the effects of the vaccinations by recording any symptoms experienced by the volunteers, and by analysing samples of their blood. The research will take place at the St Mary's Hospital campus of Imperial College London, UK. The DNA component of the vaccine is an experimental substance, so we will monitor very closely the wellbeing of the men and women who participate in the research.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  13/EE/0010

• Date of REC Opinion

  21 Feb 2013

• REC opinion

  Further Information Favourable Opinion