HIV-CORE002

• Research type

  Research Study

• Full title

  A randomized single-blind placebo-controlled study to evaluate the safety and immunogenicity of three candidate HIV-1 vaccines, pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv, administered in combination to healthy, HIV-1-uninfected adults.

• IRAS ID

  48061

• Contact name

  TomÇ­­ Hanke

• Eudract number

  2010-018439-16

• ISRCTN Number

  not issued

• Research summary

  HIV-1, the virus that causes AIDS, continues to spread in a virtually uncontrolled manner. The most efficient and possibly only way to change this alarming situation is to develop a safe, effective and accessible preventive vaccine. Arguably the biggest challenge in developing such a vaccine is the enormous variability of HIV-1, which dwarfs almost any other infection. However, there are regions within proteins of HIV-1 which do not vary. These conserved viral parts seem to be essential for the virus to remain infectious. We have taken advantage of this and developed a vaccine strategy designed specifically to overcome HIV-1 variability by focusing the body??s immune defences on the conserved viral parts. A series of three vaccines are used in combination: they consist of the same HIV-1-derived component, which is totally synthetic and inserted into three different carriers (??vectors??). Using three different vaccines in this way is called ??prime-boost?? and is thought to be the most effective way to stimulate a strong immune response. We shall test this approach in a small phase I/IIa study in 32 healthy, HIV-1-negative adult volunteers in Oxford. We will assess the safety of the vaccination strategy and its capacity to stimulate effective immune responses against HIV-1. The participants will attend between eight and eleven visits when they will receive between one and five vaccinations or placebos and will give a total of no more than 600 ml of blood. The visits will continue for a period of up to 28 weeks. If the results from this study are encouraging, we plan to carry out further testing of the vaccination strategy in larger clinical trials. The study is funded by the Medical Research Council, UK.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/52

• Date of REC Opinion

  30 Jul 2010

• REC opinion

  Further Information Favourable Opinion