What is the purpose of this study?
The purpose of this research study is to test the safety of the VSV-Ebola vaccine and its ability to trigger an immune response against Ebola virus, at 2 different doses.
How is the study designed?
Participants will be randomly selected to receive either of two doses (10 or 50 million vaccine particles) of the VSV-Ebola vaccine OR placebo as a one-time injection. (Participants who are healthcare workers (HCW) that may deploy to Ebola-affected countries will not receive placebo.) Neither the participant nor study investigators will know which treatment the participant receives. All participants will be followed closely during the first 2 weeks and then periodically for six months to assess the vaccine’s safety and ability to trigger immune responses against Ebola virus.
Who may consider participating in this study?
To maximize safety, the study is only open to adult volunteers aged 18 to 65 years. Females of childbearing potential should be neither pregnant nor nursing. All volunteers will have to be free of significant and active health problems (as determined by the information you provide, a physical exam and laboratory tests for “screening”). Those with a history of severe allergic reactions (including after vaccination), active hepatitis B or hepatitis C or HIV infection, or confirmed or suspected immunodeficient conditions (e.g., cancer, immunosuppressive therapy) will not be eligible to participate. If you have received an inactivated (or “killed”) vaccine (including seasonal influenza!) in the 14 days, or a live vaccine within 30 days before screening, participation will have to be postponed. Thus if you wish to participate, you are advised to complete your vaccinations without delay. Other exclusion criteria will apply to minimize the risk of poor outcomes.
As a precautionary measure common to all studies testing new vaccines or medications, to minimize potential risks, volunteers will be asked to use effective methods of contraception for 28 days following injection (men) or throughout the course of the study (women of childbearing age). In addition, volunteers will be asked to use barrier methods (latex condoms) during penetrative sexual intercourse, to avoid the sharing of needles, razors, or toothbrushes and to avoid open-mouth kissing in the 7 days after injection. Participation is not open to volunteers who live with someone immunodeficient, HIV-positive, pregnant or with an unstable medical condition.
What will be required to participate in this study?
The first step will be to be thoroughly informed of the study, to take sufficient time to decide whether to participate, and, should participation be granted, to provide written consent.
The study includes 9 visits at the Clinical Trials Unit of the University Hospitals of Geneva (HUG) over a 6-month study period. The first visit will be an information and screening visit. If participation is granted, an interview and a physical exam will be performed and urine and blood will be collected.
This will take 1 to 1 and a half hours. On the second visit, there will be a brief interview and blood samples will be taken. The vaccine (at 10 or 50 million vaccine particles) or the placebo (non-deployable volunteers only) will be injected into the arm. The participant will then be observed closely for 1.5 hours; the visit will take 2 hours total. In the 7 days following the injection, participants will be asked to record any symptoms into a diary. Study participation entails remaining in the Geneva area for 14 days following the injection.
This clinical trial is now full of volunteers.