EuroVacc 03/ANRS vac20
A trial to compare the immune responses and safety of two versus three DNA HIV vaccine primes in combination regimens with a pox vector boost in healthy volunteers
Testing people’s immune responses to two courses of vaccinations to prevent HIV
What is 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 treating all infected individuals is beyond the scope of the public health services.
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 protect people from the HIV virus. But despite considerable effort, there still is no HIV vaccine which has been proved to protect people from the HIV virus. Nevertheless, research teams continue to develop new products and approaches.
EV03 is a trial of two different courses of vaccinations which may prevent HIV. Both of these use different types of DNA: HIV-C and NYVAC HIV-C. NYVAC is based on the virus which was used as a vaccine to prevent smallpox. DNA HIV-C consists of two pieces of DNA. Both of these products have been tested in humans before.
Those who take part in this trial will be randomised into two groups. Both groups will be given both vaccines, but in different combinations: half will receive 3 DNA HIV-C and 1 NYVAC HIV-C and half will receive 2 DNA HIV-C and 2 NYVAC HIV-C.
In a previous trial, the immune cells of most people who were given 2 DNA HIV-C and 2 NYVAC HIV-C showed a good response in laboratory tests. We now want to see if using 3 DNA HIV-C primes can further improve these immune responses. We also want to confirm the results of previous trials which suggest these products are safe to give to people.
Type of study
Who is funding the study?
1. European Commission. Ref: QLK2-CT-2002-01431; 2. French National Agency for AIDS Research (Agence Nationale de Recherches sur le SIDA [ANRS]).
When is it taking place?
This trial opened to recruitment in August 2007. Enrolment was completed in June 2008 and final follow up took place in early November 2009.
Where is it taking place?
Three EuroVacc sites co-ordinated by the MRC CTU - Imperial College, St Mary's Hospital, London, UK; Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland and Klinikum Universität Regensburg, Germany.
Five ANRS sites co-ordinated by INSERM U897 – Cochin, Mondor, Tenon, Toulouse and Marseille.
Who is included?
A total of 147 healthy volunteers at low risk of HIV infection have been included.