Reference number: | 01KA1202 |
Funding amount: | 779.815 EUR |
Funding Period: | 2012 - 2017 |
Project leader: | Prof. Dr. Michael Hölscher |
Address: |
Klinikum der Universität München, Abt. für Infektions- und Tropenmedizin Leopoldstr. 5 80802 München |
The project is part of a multicentric Afro-European clinical trial (Phase IIa) for the development of an HIV vaccine under the European and Developing Countries Clinical Trials Partnership (EDCTP). It involves the vaccination of a total of 200 volunteers with a DNA/MVA/gp140 HIV vaccine under the EDCTP programme. This project involves a trial with 80 volunteer subjects from Mbeya, Tanzania conducted by the NIMR in Mbeya, a partner institution of LMU University of Munich. The vaccine is an innovative DNA vaccine consisting of seven plasmids which correspond to parts of certain HIV genes (env, rev and gag). The vaccine is applied a total of three times (weeks 0, 4 and 8) followed by an examination of immune response. The additional effect of an electroporation (short electric pulses at the site of immunization) is tested for improved immune response in a further 100 volunteer test persons. A so-called boost vaccination is also tested to try to improve immune response. The MVA vaccine used for this purpose (also a DNA vaccine) contains env, gag and pol. MVA is applied a total of two times (weeks 16 and 34) as a booster. The study protocol was submitted to the ethics commissions in Mozambique and Tanzania at the end of 2011. Approval for the trial was expected for August 2012. The clinical database and the SOPs were to be established by this time so that the study centres could start recruiting patients by the start of 2013.