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 was 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 tested (CN54gp140) had previously been shown to be well-tolerated when given to a small number of women intravaginally. This study looked 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 assessed how well the vaccine stimulated the body’s immune system by testing blood in the laboratory.

What difference did this study make?

We found that three intramuscular injections produced significantly stronger immune responses than intravaginal or intranasal administration. However, after a single intramuscular boost participants primed by three intranasal vaccinations had a robust response, and interestingly the strongest cellular immune responses. We looked at two different intramuscular doses – a standard one of 100mcg and a lower one of 20mcg - and found the lower dose to be similarly good at eliciting immune responses.

Type of study

Randomised trial

Contact details

Who funded the study?

The Wellcome Trust under Grand Challenges in Global Health Initiative and the UK HIV Vaccine Consortium (UKHVC).

When did it take place?

From November 2011 until November 2012.

Where did it take place?

St Georges Hospital, London and York Hospital, York.

Who was included?

Females aged 18 to 45 years at low risk of acquiring HIV.