ICOX PB001
A two-centre, randomised, double-blinded phase I study to evaluate the safety and immunogenicity of 2 doses of candidate HIV-1 Clade A DN/A vaccine or placebo followed by a candidate HIV-1 Clade A MVA vaccine or placebo in healthy volunteers at low risk of HIV infections
A trial to test the safety of two vaccines that might be used to protect against HIV
What was this study about?
This trial aimed to look at the safety of two types of vaccine which might be used as a vaccine to protect against HIV. It also looked at the ability of these drugs to stimulate an immune response. People who took part in this study were divided at random into two groups. People in one group were given a vaccine called clade A DNA vaccine twice, and then a vaccine called clade A MVA. (Clades are a way of classifying HIV based on the genetic make up of the HIV virus – clade A is most common in Africa.) People in the second group were given injections that contained a placebo.
What difference did this study make?
This study set the basis for later clinical trials and demonstrated the safety of these vaccines.
Type of study
Randomised trial
Contact details
Who funded the study?
This trial was funded by the International AIDS Vaccine Initiative (IAVI). IAVI is a global not-for-profit, public-private partnership working to accelerate the development of a vaccine to prevent HIV infection and AIDS.
When did it take place?
This study began recruiting people in 2002 and closed in 2004. The results were published in 2008.
Where did it take place?
People who took part in this study were recruited in two centres - St Mary’s Hospital, London and the Churchill Hospital, Oxford.
Who was included?
119 healthy HIV-negative volunteers took part in this study.