UK HVC Spoke 003

• Research type

  Research Study

• Full title

  A Phase I clinical trial investigating immunisation strategies using DNA, MVA and rgp140 adjuvanted with GLA-AF to maximise antibody responses.

• IRAS ID

  111852

• Contact name

  Sheena McCormack

• Eudract number

  2012-003277-26

• ISRCTN Number

  n.a

• Research summary

  This is a phase I study exploring the safety and potency of five HIV vaccines in healthy volunteers. The main aim is to see whether three of the five vaccines can be given together rather than one after the other, in five rather than seven sets of vaccinations and a course shortened by eight weeks. All volunteers will receive three injections of the first two vaccines (DNA plasmids) and half will be randomly assigned to receive two injections each of the second (MVA-C) and subsequent vaccines (CN54rgp140 mixed with GLA-AF) during the same visit or two injections of the MVA-C followed by two of CN54rgp140 mixed with GLA-AF. We are interested in ensuring that the vaccines are safe and also that the immune responses in the two groups of volunteers are similar. The three vaccines have all been shown to stimulate the immune response to specific parts of the HIV virus and none are infectious. The first vaccine consists of two DNA plasmids. When injected into muscle cells small parts of the HIV virus which are encoded by the DNA are produced and these are then recognised by the immune system. The second vaccine MVA-C, is derived from vaccinia virus which has been modified so that it cannot divide. The virus (MVA) actually expresses the same portions of HIV as the DNA and results in amplification of the responses seen. The third vaccine's a synthetically produced component of the HIV viral outer coat and it will be administered with an additive which has been shown to greatly enhance particular types of immune response which have recently been shown to play a role in protection against infection.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  13/LO/0115

• Date of REC Opinion

  21 Mar 2013

• REC opinion

  Further Information Favourable Opinion