In collaboration with the World Health Organization, the University Hospitals of Geneva (HUG) are conducting a phase 1 trial to test the safety of the Ebola vaccine VSV-ZEBOV and its ability to trigger an immune response in healthy adult volunteers.
- The VSV-Ebola vaccine contains a recombinant (modified) form of the vesicular stomatitis virus (VSV). The VSV envelope has been replaced with the envelope from the Zaire strain of the Ebola virus in order to trigger the production of antibodies against Ebola. Because the vaccine is made from the VSV virus, there is no risk of contamination with Ebola virus.
- VSV-ZEBOV protected non-human primates exposed to lethal doses of Ebola virus after vaccination. It is only just beginning to be tested in humans. A few frontline workers were immunized in a post-exposure setting. The potential adverse events are thus yet unknown.
- The trial will compare 2 different doses of the vaccine to each other and to a placebo to determine whether they differ in the adverse reactions and immune responses they trigger.
- The participation of volunteers who could potentially deploy to Ebola-affected countries (“deployable”) will be prioritized. Deployable volunteers will not be randomized to placebo.
- The vaccine is still experimental in humans and no protection against Ebolavirus can be assumed, thus no direct benefit to participating in this study can be inferred. Should you be exposed to Ebola virus, an enhanced risk of infection or of a more severe infection cannot yet be formally excluded.
- The trial will consist of 9 visits (including a pre-enrollment screening) at the Clinical Trials Unit of HUG over 24 weeks. The first 2 visits will last 1.5 – 2.0 hours, the remaining visits 20-30 minutes each.
- For deployable subjects some visits may be conducted remotely, but a minimum 14-day stay in the Geneva area is required after vaccination to allow prompt evaluation, if needed.
- Participation will be anonymous and all data will be handled in a confidential manner.
- Remuneration for study participation is 810 CHF (roughly $845).