A Phase I clinical trial to assess the safety and immunogenicity of three HIV CN54gp140 immunisations administered through the intramuscular, intranasal and intravaginal routes in healthy female volunteers
Is the CN54gp140 HIV vaccine safe to use, and does the way it is given influence how it triggers the immune system?
What is this study about?
An HIV vaccine is widely considered to be one of the most effective and sustainable ways of reducing the rate of new infections. At present, it isn’t clear which route of giving an HIV vaccine is best at being able to stimulate the immune system and prevent the virus from being acquired through sex.
The vaccine we are testing (CN54gp140) has previously been shown to be safe when given to a small number of women intravaginally. This study will look at giving the same potential HIV vaccine in four different combinations using three different routes – intramuscularly, intranasally and intravaginally - and in three different concentrations.
As well as assessing the safety of a new potential HIV vaccine we will also assess how well the vaccine stimulates the body’s immune system by testing blood in the laboratory.
Type of study
Who is funding the study?
The Wellcome Trust under Grand Challenges in Global Health Initiative and the UK HIV Vaccine Consortium (UKHVC).
When is it taking place?
From November 2011 until November 2012.
Where is it taking place?
St Georges Hospital, London and York Hospital, York.
Who is included?
Females aged 18 to 45 years.