7. Phase I clinical trials

So far, candidate vaccines that have either been completely (DNA-C) or partially (NYVAC-C; Aventis-Sanofi: NYVAC technology and GMP production) developed in our lab have been tested in two phase 1 clinical trials in London (Imperial College; Prof. J. Weber) and Lausanne (CHUV; Prof. Guiseppe Pantaleo), respectively. In preparation of the clinical trials, our lab prepared the data on vaccine immunogenicity, and was involved in the design of the toxicological analysis as well as in the preparation of the regulaory files (investigators brochure, CTX, clincal trial agreement etc.)

Study EV01 focussed on safety and immunogenicity of NYVAC-C in HIV-negative volunteers with no risk for HIV infection. 20 individuals received two intramuscular administrations of ~ 107 TCID50 NYVAC-C, 4 individuals were injected with saline only. The vaccine was well tolerated with no or very mild side effects. About 50% of the vaccinated individuals developed - according to a rigorous ELISPOT readout - significant levels of ╬│IFN producing T cells at one or several time points. T cell resonses to Env were unexpectedly more pronounced than those to Gag, Pol or Nef, and were primarily MHC class II-restricted.
EV02 determined the impact of two priming immunizations with DNA-C (4 mg each, i.m., 2 sites, 4 wks intervals) on the outcome of two NYVAC-C booster immunizations at week 20 and 24. This study is still ongoing, first results are expected this year. However, a primate trial which exactly followed the clinical trial protocoll, indicated that the prime / boost regimen is by fare more efficient compared to the "NYVAC-only" protocol in terms of (i) number of responders, (ii) number of recognized epitopes, (iii) breadth of cytokine responses and (iv) magnitude of cytokine producing T cells.


Upcoming Meetings
> more


We permanently offer several opportunities for students to conduct research projects in the context of `Forschungs- und Schwerpunktpraktika┬┤.
> more