CUT*HIVTHER 001
Research type
Research Study
Full title
A randomized phase I/II study to assess the safety and immunogenicity of the DNA-GTU vaccine administered by two novel routes compared to placebo in HIV-infected patients on antiretroviral therapy
IRAS ID
146534
Contact name
Sheena McCormack
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Eudract number
2013-004023-37
Duration of Study in the UK
1 years, 9 months, days
Research summary
CUT*HIVTHER 001 is a randomised Phase I/II study comparing the safety and immunogenicity of different ways of delivering an HIV vaccine to volunteers infected with HIV. HIV-infected male and female volunteers aged 18 to 45 years old (n=30), infected with HIV and treated for HIV for at least 6 months will be invited to join the trial. The participants will be divided into 2 groups.
Group 1 (one) will have the vaccine (N=10) or sodium chloride BP placebo (N=5)injected into the muscle of the upper thighs with added ‘electroporation'–the use of a small pulse of electricity to increase the amount of vaccine that goes into the cells.
Group 2 (two) will receive the vaccine (N=10) or sodium chloride BP placebo (N=5) into the skin ‘transcutaneous’ as well as into the muscle, but without the ‘electroporation’ for the latter route.
The 'transcutaneous' administration involves application of a water-based solution onto the surface of the skin of the upper arm, after the hairs in a small area have been removed. The product enters the body through the hair follicles.
The vaccine is a DNA copy of key HIV genes which we hope will stimulate a strong immune response to the HIV. The study will look at how good the vaccine is at stimulating the immune response and assess if these methods of administering the vaccine are safe.
Participants will receive 3 vaccinations over 12 weeks. Side-effects will be recorded and diary cards and following interviews and examination in the clinics, and through routine blood tests. The DNA is an experimental substance so the participants will be monitored very carefully. The trial will take place at St Mary’s Hospital, London.
Immune responses will be assessed in the research laboratories at St Mary's Hospital and in collaborating laboratories worldwide.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/1246
Date of REC Opinion
20 Jan 2015
REC opinion
Further Information Favourable Opinion