THERAVAC

Evaluation of a Therapeutic Vaccination Strategy for HIV-1 Infection TheraVac

Framework programme:

5

Project number:

QLK2-CT-2002-01299

EC contribution:

€ 3 000 000

Duration:

48 months

Type:

RS

Starting date:

October 2002

Keywords: HIV-Vaccines; antiretroviral therapy; CD4 T cells to HIV CD8 T cell to HIV; reccombinant attenuated pox virus; NYVAC- MVA – ELISPOT

Summary:

Highly active antiretroviral therapy (HAART) dramatically decreases in HIV-related morbidity but does not eradicate HIV and is associated with severe toxicities. Lifelong therapy with antiretroviral agents in HIV infection is not possible for reasons of toxicity. Therapy interruptions are common but are limited by virus relapses. A strategy that would significantly prolong therapy interruptions is the only option for long-term management of HIV infection.

Expected results:

A principal deliverable of TheraVac is to show that the combination of the two new vaccines produced in Europe with antiretrovirals can limit time on therapy. Such a strategy should decrease the antiretroviral drug toxicity and cost for the European community.

Aims:

The objectives of TheraVac are to demonstrate the following in phase I/II clinical trials on HIV-infected patients successfully treated with HAART:

1) the safety of new highly attenuated NYVAC and MVA HIV-recombinant vaccines produced in clinical grade conditions by  EuroVac
2) their ability to restore the immune control of HIV and to increase numbers and breadth of HIV-specific T cells measured by using a European standard ELIspot assay for monitoring T-cell responses
3) the vaccine efficacy based on their ability to allow HAART interruptions for prolonged periods of time by controlling virus replication and protecting against CD4 cell depletion.