A phase I trial to assess the safety of 4 ml DNA C (intramuscular [IM]), and the safety and immunogenicity of DNA C followed by NYVAC C (IM) in an open, randomised comparison to NYVAC C alone in healthy volunteers at low risk of human immunodeficiency virus (HIV) infection
A trial to test the safety of a possible vaccine to prevent HIV
What was this study about?
Around the world, about 11,000 people are infected with the HIV virus every day, and AIDS is now the fourth commonest cause of death worldwide. Even though effective treatment is available, over 90% of HIV infections occur in developing countries, where governments find it hard to treat everyone who is infected with the virus. But even in populations where treatment is widely available, such as homosexual men in developed countries, the epidemic persists. So researchers want to develop a vaccine to prevent the HIV virus from spreading.
EV02 was a phase I trial. It aimed to test whether a vaccine called DNAC could safely be used alongside a drug called NYVAC C.
What difference did this study make?
This trial found that it was safe to give the DNAC vaccine to humans. These results enabled researchers to plan a phase II trial of the vaccine.
Type of study
Who funded the study?
The Eurovacc Foundation, a not-for profit organisation which aims to develop safe and effective vaccines to prevent HIV/AIDS.
When did it take place?
This trial recruited volunteers in 2005. The results of the trial were published in 2008.
Where did it take place?
St Mary’s Hospital, London, and Centre Hospitalier Universitaire Vaudois (CHUV) in Switzerland.
Who was included?
40 healthy people who were HIV negative.