DNAVAC 001
Research type
Research Study
Full title
DNAVAC001: A Phase 1 open-labelled trial to optimise DNA vaccination for antibody induction
IRAS ID
161934
Contact name
Robin Shattock
Contact email
Sponsor organisation
Joint Research Office
Eudract number
2014-001997-33
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
We are testing a vaccine, which consists of DNA that directs human cells to produce a protein that stimulates the body’s immune system to generate protective antibodies against the Human Immunodeficiency Virus (HIV). In this study we wish to work out the best conditions for using this DNA. Previous animal and human studies have shown that antibody responses to DNA vaccines can be influenced by the dose (amount of DNA), route of injection (into the muscle or skin), and use of electroporation (EP), which consists of mild millisecond electrical pulses at the site of injection. This greatly increases the amount of vaccine getting into cells, playing an important role in how well a vaccine works. Combining this vaccine with another type of DNA that promotes production of a natural human protein (recombinant IL-12) may further improve the way the vaccine works. Similar DNA vaccines have been tested in a number of clinical trials and found to be safe. In this study the vaccine will be administered by injection into the muscle (intramuscularly), skin (intradermally) or both (in thigh and/or upper arm) with and without DNA for recombinant interleukin 12, together with electroporation. We will invite healthy men and women to take part in this research. A total of 40-48 will be enrolled and each will receive four vaccinations over the course of 4-6 months. We will assess the effects of the vaccinations by recording any symptoms and by analysing blood samples over 6-9 months depending on vaccination schedule. The vaccine is already being studied in a small numbers of men and women by the IM route and to date has not caused any serious adverse events. However it has not previously been administered by electroporation with or without DNA for IL-12. Safety and efficacy will therefore be monitored extremely closely.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1968
Date of REC Opinion
2 Mar 2015
REC opinion
Further Information Favourable Opinion